Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial
Phase: NA
Conditions: Menopause
Sponsor: University of South Wales

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Cover Page: 
 
Title: Symptom Monitoring benefits physical and emotional 
outcomes during Menopause  
 
Date submitted for review: October 2020 
 
Date accepted: January 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PART A 
N.B. All questions should be addressed (e.g. provide an answer or state why not 
applicable).  
 
 
1. RESEARCH STUDY TITLE: 
 
A randomised controlled trial of the effects of monitoring physical and emotional symptoms among 
menopausal women. 
 
 
2. NAME OF PRINCIPAL INVESTIGATOR:  
Robin Andrews 
QUALIFICATIONS:  
BSc Psychology  
JOB TITLE: PhD student 
EMAIL: robin.andrews@southwales.ac.uk 
 
ADDRESS (IF NOT STAFF OF USW): N/A 
 
 
3. CO-INVESTIGATOR(S):  
 
Director of Studies and academic supervisor: Dr Deborah Lancastle 
 
Second supervisor: Professor Bev John 
 
 
4. IMPERATIVE: Please provide the EFAS number for this project (available from the Research Governance 
Officer): 
21059 
 
5. i) DOES THIS PROPOSAL REPRESENT PART OF AN EDUCATION/TRAINING PROGRAMME?  
     (If you answer YES to this question, please complete part ii below)   
 
 
YES                             
 
ii) IF YES, WHAT QUALIFICATION WILL THIS THE PROJECT LEAD TOWARDS? 
 
 
This research is part of a KESS-2 funded PhD project  
 
 
6. BACKGROUND AND CONTEXT / RATIONALE 
 

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Evidence suggests that up to 90% women in the UK will experience severe menopausal symptoms (Hunter 
et al., 2001). Despite this, it has been reported that few women will seek medical help, and most will not 
access treatment until their symptoms have become extremely bothersome (Constantine et al., 2016). 
Unfortunately, those that do seek treatment for menopause are likely to face barriers to effective 
healthcare, with some reports suggesting that many women struggle to adequately communicate the 
totality of their menopausal symptoms to health professionals (Ismail et al., 2016; Woods et al., 2015). 
 
Robin Andrews recently conducted a systematic review (submitted for publication) which demonstrated 
that symptom monitoring reduced women’s reports of menopausal symptoms, such as hot flushes, urinary 
incontinence, headaches, reduced libido, and depressed mood. The systematic review also demonstrated 
that symptom monitoring increased health awareness and facilitated patient-doctor communication, 
decision-making, and treatment goal setting, all of which are antecedents for improved medical treatment 
outcomes (Ha & Longnecker, 2010). In the randomised trials included in this review, however, symptom 
monitoring was used as a control intervention against which another intervention (e.g., paced respiration) 
was compared, and the findings of benefits in the symptom monitoring control group were largely under 
recognised and rarely discussed (Sternfeld et al., 2014; Carpenter et al., 2012).  
 
7. AIMS AND OBJECTIVE(S) OF THE RESEARCH STUDY:  
 
It is important to further our understanding of the extent to which symptom monitoring alone could be a 
useful intervention to support menopausal women. Should monitoring be beneficial, it has the potential to 
offer women a useful and economical way of improving their wellbeing when waiting for treatment, or for 
women who choose not to receive treatment for menopausal symptoms, or for whom medical treatment 
is contra-indicated. Thus, a randomised controlled trial (RCT) will be conducted in the proposed research 
because symptom monitoring as a stand-alone intervention for the menopause has not yet been evaluated 
experimentally.  
 
The primary objective of the proposed study is to experimentally investigate symptom monitoring among 
menopausal women. The key outcome of interest will be whether daily symptom monitoring influences 
physical and emotional menopause symptoms, help-seeking, health and symptom awareness, willingness 
to engage in patient-doctor communication, and perceptions of efficacy in treatment decision-making and 
goal setting, compared to women who are not asked to monitor their symptoms.   
To explore whether daily symptom monitoring can influence physical and emotional menopausal 
symptoms, this trial will employ the Daily Record Keeping form. The DRK was developed to assess women’s 
daily reactions to IVF treatment (Boivin, 1997; Boivin & Takefman, 1995, 1996) and has since been employed 
in a number of fertility studies which have charted daily symptom changes (Lancastle, 2006; Ockhuijsen et 
al., 2014; Bailey et al., 2015). These studies have demonstrated symptom improvements following 2-weeks 
of using the DRK. The DRK was adapted for the present study to include physical and emotional menopause 
symptoms, based on the British Menopause Society's index of the most-commonly experienced menopausal 
symptoms (2016). 
Care will be taken when interpreting the results of the DRK, because a number of factors influence symptom 
reports. For example, individuals who live alone are more likely to report a greater number of physical 
symptoms and succumb to physical illnesses than those who live with others (Pennebaker, 2012). Likewise, 
single, unemployed people are more likely to report a greater number of symptoms than individuals in a 
relationship and employment (Pennebaker, 2012). Because these factors interact with symptom reports, 
they will be relevant when assessing for covariates during this research (Pennebaker, 2012). 
Evidence from the systematic review also indicated that symptom monitoring might induce health-related 
behavioural changes. Thus, help-seeking intentions will be explored as prior evidence suggests that 
symptom monitoring can lead to an increased intention to seek medical help (Shafran et al., 2019). 
Furthermore, difficulties in communicating symptoms can act as a barrier to help-seeking, and findings from 
the systematic review suggest that symptom monitoring may increase willingness to communicate with 
health providers (Salaheddin & Mason, 2016; Ismail et al., 2016; Woods et al., 2015). Decision-making 

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efficacy will also be explored as the systematic review demonstrated that symptom monitoring is related to 
improved efficacy in making medical decisions. This evidence also suggested that symptom monitoring may 
improve an individual's ability to identify which health improvements they would like to see in the future, 
therefore goal-setting efficacy will be assessed. Lastly, health awareness will be explored following evidence 
from the systematic review which suggested that symptom monitoring increased awareness of symptoms, 
which was subsequently associated with symptom improvements (Stensland & Malterud, 2001).  
 
A secondary objective is to explore the potential moderators of the impact of symptom monitoring on 
physical or emotional symptoms.  For example, the dispositional characteristic neuroticism has been shown 
in numerous studies to lead to reports of more frequent and/or severe symptoms (Ormel, Rosmalen, & 
Farmer, 2004; Lagoe & Atkin, 2015). Trait neuroticism is important to explore in this research as it has 
empirically been associated with increased reports of health anxiety. Increasing evidence suggests that the 
relationship between trait neuroticism and health anxiety is mediated by health information seeking (Lagoe 
& Atkin, 2015). Therefore, it’s important to assess whether health information, as supplied by symptom 
monitoring, could instigate heightened health anxiety in individuals with high neuroticism scores. Moreover, 
neuroticism has been related to increased reports of physical symptoms in terms of both severity and 
frequency, even when comparing objectively healthy populations (Pennebaker, 2012). This suggests that 
individuals scoring high on trait neuroticism may tend to report an increased number of symptoms, and this 
effect will be important to explore in regard to evaluating the symptom monitoring intervention. 
Monitoring and blunting coping tendencies have also been shown to influence the extent to which 
individuals prefer to pay close attention to their wellbeing or avoid thinking about it (Murris & Van Zuuren, 
1992; Miller, 1987). Those who employ monitoring to cope with health problems will actively seek out health 
information, whereas those who employ blunting will adopt distraction strategies in order to actively avoid 
health information (Miller, 1995). This information seeking preference is important as evidence suggests 
that acquisition of health information can lead to increased health anxiety in individuals who exhibit 
monitoring coping preferences (Miller, 1995). In the case of menopausal symptom monitoring, women’s 
attention is drawn to information about their menopausal wellbeing, which may be anxiety provoking.  
Therefore, this measure will help us understand whether symptom monitoring is more or less effective as 
an intervention for women, depending on their health information-seeking preferences.  
It is important to establish for whom symptom monitoring might be most helpful, or conversely taxing or 
even harmful should it challenge a dispositional tendency to avoid focusing on wellbeing. Indeed, coping 
style and neuroticism have both been associated with increased health anxiety following the procurement 
of health information (Lagoe & Atkin, 2015; Miller, 1987). Therefore, health anxiety will also be measured 
during this research to explore whether symptom monitoring influences it, and whether this effect is related 
to neuroticism or coping preferences.  
 
A third objective is to investigate whether participants attribute the act of monitoring to any perceived 
improvements, or whether participants attribute other elements of research participation to their improved 
health (i.e. increased menopausal awareness), or whether participants do not perceive any improvements 
whatsoever. Studies which have included symptom monitoring as a control intervention often speculate 
that involvement in research is responsible for the positive outcomes found in the control group, rather 
than symptom monitoring in itself (Borud et al., 2010). However, these studies rarely provide data on this 
assumption. Therefore, the present study aims to establish whether participation in menopausal research 
per se improves wellbeing, regardless of what that participation entails.  
 
Summary of objectives:  
 
• 
Investigate whether daily symptom monitoring influences psychological, physical and behavioural 
health outcomes compared to a non-monitoring control group.   
 
• 
Assess whether personality and coping style moderate the impact of symptom monitoring on 
physical or emotional health outcomes during the menopause.   

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• 
Identify whether participants attribute any health improvements to symptom monitoring, or other 
elements of their research participation.   
 
8. STATEMENT OF STUDY DESIGN (E.g. RCT, Crossover, Cohort studies, Case control, Action research, etc.  
Max 700 words) 
 
This study will employ a 2-arm randomised controlled trial, including 1 symptom monitoring intervention 
group and 1 non-monitoring control group. The main analysis will be a 2 by 2 mixed between/ within-
subjects ANOVA. The between-subjects component will compare symptom differences between the 
symptom monitoring intervention group and the usual care control group. The within-subjects component 
will compare symptom changes between baseline and after 2-weeks of daily symptom symptom 
monitoring, and between baseline and after an interval of 2 weeks without monitoring, in the control group. 
The interaction will establish whether symptom changes differ over time according to whether women are 
in the symptom monitoring or control group. It is expected that improvements in well-being will occur over 
time in the symptom monitoring group, in comparison to the control group e.g., positive reactions will 
increase from baseline, whereas negative reactions will decrease. Symptom reports will be collected using 
the DRK (Boivin & Takefman, 1995). The intervention group will record their symptoms at baseline and every 
day for 2-weeks (although only baseline to follow up changes will be subject to analysis), the control group 
will record their symptoms at baseline and after an interval of 2-weeks with no daily monitoring.  The DRK 
has been used previously in randomised trials of women’s reproductive health (e.g., Boivin & Takefman, 
1995; Ockhuijsen et al., 2014) to establish the effects of symptom monitoring. This research will take place 
electronically, questionnaires will be presented to participants in the form of JISC Online Surveys and 
accompanying information will be attached to emails as Word documents. This study has been designed in 
this way in response to the ongoing 2020 COVID-19 pandemic. The study admin will be managed by Robin 
via a dedicated USW email address: theresearchteam@southwales.ac.uk. 
 
Research design figure: 
 
All participants: 
 
Both groups will complete a number of measures at baseline and at 2-week follow up, using surveys 
presented via JISC Online Surveys. Baseline measures will be: demographics, coping style, and trait 
neuroticism, as well as physical and emotional menopause symptoms (as measured using the DRK), health 
anxiety, help-seeking intentions, health and symptom awareness, willingness to engage in patient-doctor 
communication, and perceptions of efficacy in treatment decision-making and goal setting. Participants will 
be asked on the baseline questionnaire whether they would like to be sent text message reminders to help 
them remember to complete the surveys. Those who answer “Yes” will be asked to supply their mobile 
phone number. Participants will also be given the option of opting out of being sent text reminders 
throughout the duration of the study. This is in case participants find receiving daily text messages invasive, 
annoying, or not useful. Therefore, allowing participants to opt out gives them the option to change their 

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mind. See Appendix 1 to view the baseline survey in Word document format. Prior to being presented 
with the information sheet, consent form, and baseline survey questions, participants will be asked three 
screening questions which will assess study eligibility. See Appendix 2 to view the screening questions. The 
screening questions with the information sheet and consent form and main baseline survey questions, as 
presented 
on 
JISC 
Online 
Surveys, 
can 
be 
viewed 
via 
this 
link: 
https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-preview  
 
After 2 weeks, outcome questionnaires will be administered again (on the 15th day after the 14-day 
monitoring period) alongside a measure which will assess whether participants believe their research 
participation is related to any improvements in their health or wellbeing, and a single-qualitative item which 
will assess participant experiences of dealing with the menopause during the Covid-19 pandemic. The 
measures to be administered again include: the General help seeking questionnaire (GHSQ) which will 
assess help-seeking, health anxiety will be assessed using the Health Anxiety subscale extracted from The 
Health Orientation Scale (HOS), patient-doctor communication will be assessed using The Willingness to 
Communicate about Health (WTCH) Measure, decision-making will be assessed using the Decision Self-
Efficacy Scale (DSE), goal-setting efficacy will be assessed using the General Self Efficacy Scale (GSE), health 
awareness will be assessed using the Health Consciousness (HC) subscale extracted from HOS, changes in 
physical symptoms after 2 weeks will be evaluated using the DRK, and 3 qualitative items will assess 
perceived effects of research engagement.  A final qualitative item will also be used to assess participants’ 
experiences in dealing with the menopause during the Covid-19 pandemic. Trait neuroticism and 
monitoring/ blunting coping styles will not be reassessed at follow-up as it is not expected that these 
dispositional variables will alter as a result of the intervention after 2 weeks. See Appendix 3 to view the 
follow-up survey in Word document format. The follow-up survey as presented on JISC Online Surveys 
can be accessed via this link: https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-preview 
 
Intervention group: 
 
Participants in the intervention group will be invited to monitor their physical and emotional symptoms 
every day for 14-days using the Daily Record Keeping form (DRK; Boivin & Takefman, 1995), administered 
via JISC Online Surveys. See Appendix 4 to view the daily DRK survey in Word document format. The online 
DRK survey can be viewed as it’s presented on JISC Online Surveys via this link: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-form-preview. At 10am each day of the 
intervention period, participants in the intervention group will be sent an email asking them to complete 
the DRK survey by the end of the day- they will also receive text message reminders to complete the DRK at 
5pm each day, unless they opt out of reminders. Both the email and text reminders will include a link to the 
online DRK. Participants can opt out of text message reminders at any time by emailing Robin requesting to 
opt out. Once participants have returned DRK surveys every day for 14 days, on the 15th day they will be 
asked to complete the follow-up survey within 24 hours. Once they have returned the follow-up survey they 
will be sent their £20 gift voucher via email. See Appendix 5, page 1 to view a template of the daily DRK 
email reminders, see Appendix 5, page 2 to view a template of the text message reminders. See Appendix 
6, page 1 to view the email template advising intervention group participants of their group allocation, 
and instructing them to complete the DRK survey each day for 14 days. The online text messaging platform 
ClickSend will be used to manage the scheduling of daily text message (www.clicksend.com) See the section 
below titled “Data collection tools” for a more detailed explanation of the measures used in this study.   
 
Control group: 
 
Participants in the control group will not monitor their symptoms daily for 14-days and will instead be 
instructed to carry on as usual during the 2-week period, while the intervention group are monitoring. This 
group will complete all measures (including the DRK) at baseline and at follow-up on the 15th day only. See 
Appendix 6, page 2 to view the email template advising control participants of their group allocation, and 
instructing them to carry on as usual for 14 days. If they indicated on the baseline survey that they are 

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interested in receiving text message reminders, participants in the control group will also be sent a 
reminder text message to complete the follow-up survey.  
 
Hypotheses: 
 
• 
Symptom monitoring will lead to significant improvements in symptoms after 2 weeks, in comparison 
to the non-monitoring control group.   
• 
The monitoring group will report increased self-efficacy at follow up in patient-doctor communication, 
shared decision making, goal orientated behaviour, help-seeking intentions, and heightened health 
awareness, compared to the control group. 
• 
Women in the intervention group who are monitors according to their scores on the blunting and 
monitoring scale will report higher negative emotions and physical symptoms than blunters at follow 
up.  
• 
Greater Health anxiety at follow up will be predicted by symptom changes, demographics (living alone, 
employment, and marital status), coping style, neuroticism, and symptom monitoring. 
 
9. MATERIALS AND METHODS 
 
This study will use electronic means (online survey, email) and participants will receive a £20 Amazon voucher 
for completed participation. No face to face contact will occur between the research team and research 
participants.  Participants will predominantly be recruited using JISC’s online platform for connecting researchers 
with study participants (www.callforparticipants.com), as well as social media sites including Facebook and 
Instagram. Using these platforms, a research poster will be used to attract participants to the study and provide 
interested participants with a link to the screening questions, information sheet, consent form, and baseline 
survey. See Appendix 7 to view the recruitment poster as it will be presented on www.callforpartcipants.com, 
and shared on social media sites.  
 
The baseline survey (see Appendix 1) will collect the email addresses of interested participants. After submitting 
the baseline questionnaire, participants will be contacted via email with details about their group allocation and 
further instructions i.e. intervention participants will be instructed to complete 5-minute daily surveys each day 
for 14 days (see Appendix 6, page 1 for instruction email template for intervention participants), whereas 
control group participants will be asked to continue as usual for 14 days (see Appendix 6, page 2 for instruction 
email template for control participants). After the 14-day period both groups will be asked via email to complete 
the follow-up survey (see Appendix 6, page 3). The information sheet (see Appendix 8) and consent form (see 
Appendix 9) will precede the baseline survey and will provide full information about the nature of the study and 
details about what the participants in each group will be asked to do, including eligibility for he £20 incentive for 
taking part. The methodology for supplying participants with vouchers via email has been used in a previously 
approved study with no problems raised (ethics reference: 200401HR).  
To avoid participants being burdened unnecessarily by reading information about a study for which they are not 
eligible (e.g., too young or not experiencing the menopause) participants will answer screening questions which 
will assess their age, the number of hot flushes they experience per day, and their self-reported menopausal 
status. Participants will be screened out of the survey if they indicate that they are under 18, or report fewer 
than 2 hot flushes per day, and do not self-report peri- or post-menopausal status. See Appendix 1, page 1 to 
view how the screening questions will be presented on the baseline survey. See Appendix 2 to view the 
screening questions.  
 
NICE guidance recommends clinicians diagnose menopause (without the use of laboratory testing) based on 
whether a woman is not using hormonal contraception and has gone over 12 months without a period. NICE 
advises that perimenopause be diagnosed based on the presence of irregular periods and vasomotor symptoms, 
in women without a uterus perimenopause is diagnosed based on symptoms alone. Therefore, it was decided 
to use presence of vasomotor symptoms as criteria for assessing symptomatic menopausal status as this 

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encompassed both symptomatic peri and postmenopausal women, as well as women who have undergone 
surgical menopause. Furthermore, numerous RCTs which have compared variances in symptom reports 
between intervention and control groups have used 2 hot flushes per day as a criterion for assessing menopausal 
symptomology and status, and for ensuring that groups are equal in terms of menopausal symptom burden 
(Carpenter et al., 2012; Otte et al., 2013; Fraser et al., 2005).   
 
All questionnaires will be presented using the JISC online surveys platform: www.onlinesurveys.com. After 
completing the baseline questionnaire, and providing their email address, participants will be emailed within 24 
hours of completion of the baseline survey with details of their group allocation and a unique username. See 
Appendix 6, page 1 for the instruction email to intervention participants, and Appendix 6, page 2 for the 
instruction email to control participants. Participants will be asked to confirm their username at the beginning 
of each subsequent survey they complete (i.e. the DRK or follow-up survey) and in any email contact with the 
researcher.  
 
Materials: 
 
Baseline measures: 
 
Demographics and medical history (baseline only): Demographic variables to be measured are: age, 
town/country of residence, menopausal status, employment status, relationship status, living arrangements (i.e. 
are they living alone or with others?), date of last menstrual period, current medications being used (both for 
menopause and other conditions), and any current medical conditions. See Appendix 1, page 2 to view how the 
demographic and medical history questions will be presented on the baseline survey.  
 
Blunting and monitoring coping preferences as measured using the Miller Behavioural Style Scale (MBSS; at 
baseline only): this will be used to assess dispositional monitor/blunter coping preferences, which might affect 
the extent to which women benefit from or feel uncomfortable with symptom monitoring. The MBSS asks the 
recipient to vividly imagine 4 different scenarios, and then choose how they would respond to each one from a 
list of statements. These statements give an indication of whether the respondent would react to the imagined 
situation by using a Monitoring or Blunting coping strategy. Three scores can be derived from the MBSS 
questionnaire. They are: (1) the total Monitoring score; (2) the total Blunting score; or (3) the total difference 
score- Monitoring minus Blunting. To create the total Monitoring and Blunting scores simply sum the Monitoring 
items (marked “M”) and the number of Blunting items (marked “B”) respectively. Once these individual scale 
scores are created, you can simply put them into the M-B equation to create the total difference score. See 
Appendix 10, page 1 to view a copy of the original MBSS, see Appendix 1, page 13 to view how the MBSS will 
be presented on the baseline survey. 
 
Neuroticism as measured using the neuroticism scale (10 items; α = .86) from the International Personality 
Item Pool scales (NEO-IPIP-10; baseline only): this measure was chosen because it has a high reliability 
statistic, is freely available to use, is based on Costa and McCrae’s NEO Personality Inventory (NEO-PI-R) of 
which it is highly correlated (α = .82), and has been used in numerous psychological articles, all of which are 
listed on the IPIP website (https://ipip.ori.org/newPublications.htm). The IPIP is a public domain collection of 
personality measures which are based on the 16PF Questionnaire and the Big Five personality traits. See 
Appendix 10, page 3 to view a copy of the original NEO-IPIP-10, see Appendix 1, page 3 to view how the 
NEO-IPIP-10 will be presented on the baseline survey. 
 
Outcome measures: 
 
Help-seeking intentions as assessed using The General Help Seeking Questionnaire (GHSQ; α = .85): help-
seeking intentions will be assessed because prior evidence suggests that symptom monitoring can lead to an 
increased intention to seek medical help (Shafran et al., 2019). Furthermore, difficulties in identifying and 
communicating symptoms can act as a barrier to help-seeking and findings from our systematic review suggest 

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symptom monitoring may increase willingness to communicate with health providers (Salaheddin & Mason, 
2016). Therefore, we endeavour to test whether help-seeking intentions can increase following symptom 
monitoring, as mediated by heightened willingness to communicate. The GHSQ has been designed to be adapted 
to the target population under assessment, therefore the following help-seeking source was added: “Internet 
sources including health websites, online forums (I.e. Mumsnet Quora Reddit), and social media accounts (I.e. 
Twitter, Instagram, Facebook)”. “Parents" was removed as a help source, as the target population for this study 
might no longer be able to turn to their parents for help. Therefore “Other relative/ family member” was 
amended to: “Relative/ family member”.  See Appendix 10, page 4 to view a copy of the original GHSQ, see 
Appendix 1, page 4 to view how the GHSQ will be presented on the baseline survey. See Appendix 3, page 1 
to see how to GHSQ will be presented on the follow-up survey. On the baseline and follow-up surveys the 
GHSQ is titled “help-seeking questionnaire”.  
 
Health anxiety subscale extracted from The Health Orientation Scale, α = .82 (HOS; to be assessed at baseline 
and follow-up): health anxiety will be assessed to explore whether symptom monitoring influences it, and 
whether this effect is related to neuroticism or coping preferences. The HOS was developed by William E. Snell, 
and includes 10 health-oriented subscales each containing five items. The items on the health anxiety subscale 
assesses anxious feelings associated with the status of one's health. More specifically, these 
items were designed to tap people's feelings of tension, discomfort and anxiety about their physical health. 
People who endorse these items are those who experience chronic anxiety as a result of thinking about their 
physical health (Snell et al., 1991). The 5-item health anxiety subscale has good reliability, and has been used in 
numerous studies as a measure of health anxiety (Adejumo et al., 2017; Gordon et al., 2005; Snebby & Snell, 
2002). See Appendix 10, page 4 to view a copy of the original HOS including the Health Anxiety subscale, see 
Appendix 1, page 5 to view how the Health Anxiety subscale will be presented on the baseline survey. See 
Appendix 3, page 2 to see how to Health Anxiety subscale will be presented on the follow-up survey. On the 
baseline and follow-up surveys the health anxiety subscale is presented together with the health 
consciousness subscale and titled “Thoughts about health questionnaire”.  
 
Patient-doctor communication will be assessed using the Willingness to Communicate about Health (WTCH) 
Measure, α = .70: this variable will be explored following evidence from the systematic review which suggested 
that willingness to communicate about one’s health might increase following symptom monitoring. This was 
because individuals felt better able to describe the totality of their symptoms after summarising them using a 
symptom monitoring instrument (Ismail et al., 2016; Woods et al., 2015).  
The 10-item WTCH measure uses a 5-point Likert scale which asks the responder to indicate how strongly they 
agree with each statement. These statements aim to capture how comfortable the respondent feels discussing 
their health and symptoms with others. The WTCH was chosen for this study because it has been found to have 
good reliability (α = .70) as well as convergent and discriminant validity (Wright et al., 2007). See Appendix 10, 
page 6 to view a copy of the original WTCH, see Appendix 1, page 7 to view how the WTCH will be presented 
on the baseline survey. See Appendix 3, page 4 to see how to WTCH will be presented on the follow-up survey. 
On the baseline and follow-up surveys the WTCH is titled “health communication scale”. 
 
Decision-making efficacy will be assessed using The Decision Self-Efficacy (DSE) Scale, α = 0.85: This variable 
will be explored following evidence from the systematic review which suggested that symptom monitoring is 
related to improved efficacy in medical decision making. This measure includes 11 items which assess self-
confidence or belief in one’s abilities in decision making, including shared decision making, in medical contexts. 
This instrument has been used in numerous studies which have explored whether certain health interventions 
have led to improvements in decision self-efficacy within health contexts (Minneci et al., 2019; Smith et al., 
2019; Cuypers et al., 2018). Furthermore, this measure has been found to have good scale reliability (α = 0.85; 
Cuypers et al., 2018). See Appendix 10, page 8 to view a copy of the original DSE, see Appendix 1, page 8 to 
view how the DSE will be presented on the baseline survey. See Appendix 3, page 5 to see how to DSE will be 
presented on the follow-up survey. On the baseline and follow-up surveys the Decision-making self-efficacy 
scale is titled the “decision making scale”.  
 

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Goal setting efficacy will be assessed using the General Self Efficacy Scale (GSE, α = 0.76 to 0.90): This variable 
will be explored following evidence from the systematic review which found that symptom monitoring may 
improve an individual's ability to identify which health improvements they would like to see in the future.  
The GSE is a 10-item scale with a score for each question ranging from 1 to 4. The scale was created to assess a 
general sense of perceived self-efficacy. The construct of perceived self-efficacy reflects an optimistic self-belief 
that one can perform novel or difficult tasks, or cope with adversity in various domains of human functioning 
(Schwarzer, 1992). The 10 items on the GSE are designed to tap into the construct of perceived self-efficacy 
which has been positively related to goal-setting and health-related behavioural changes (Schwarzer, & Fuchs, 
1996; Schwarzer & Jerusalem, 1995). Furthermore, several studies have shown that the GSE has high reliability, 
stability, and construct validity. See Appendix 10, page 10 to view a copy of the original GSE, see Appendix 1, 
page 9 to view how the GSE will be presented on the baseline survey. See Appendix 3, page 6 to see how to 
GSE will be presented on the follow-up survey. On the baseline and follow-up surveys the GSW is titled the 
“self-efficacy scale”.  
  
Health awareness was assessed using the Health Consciousness subscale extracted from The Health 
Orientation Scale (HOS, α = 0.82): This variable will be explored following evidence from the systematic review 
which suggested that symptom monitoring could increase health awareness. The items on the Health 
Consciousness subscale refer to an awareness of one's health. These items were designed to measure people's 
tendency to think about and to reflect about their health. People who endorse these items are those who think 
about that status of their physical health, and who in general are reflective about the nature of the health and 
wellness of their body (Snell et al., 1991). This measure was chosen for its simplicity, high reliability coefficient 
(α = 0.82) and because it has been employed in a number of studies (Adejumo et al., 2017; Gordon et al., 2005; 
Snebby & Snell, 2002). See Appendix 10, page 5 to view a copy of the original HOS including the Health 
Consciousness subscale, see Appendix 1, page 5 to view how the Health Consciousness subscale will be 
presented on the baseline survey. See Appendix 3, page 2 to see how to Health Consciousness subscale will 
be presented on the follow-up survey. On the baseline and follow-up surveys the health consciousness 
subscale is presented together with the health anxiety subscale and titled “Thoughts about health 
questionnaire”. 
 
The Daily record keeping form (DRK): participants in both groups will complete the DRK at baseline and at follow 
–up. Only the intervention group will complete the DRK every day of the 2-week period.  
 
An RCT conducted by Lancastle compared outcomes of implementing a positive reappraisal coping intervention, 
with a positive mood induction control, and a daily monitoring control as measured using the DRK  (Lancastle, 
2006). This study evaluated emotional reactions and physical symptoms among women experiencing 14-day IVF 
waiting periods. This research found significant improvements in physical symptoms within the daily monitoring 
group across the 2-week waiting period which suggests that 2 weeks is an adequate amount of time to generate 
observable effects of an intervention, using daily symptom monitoring.   
 
For the present study, the DRK will be amended to include a comprehensive list of 32 menopausal symptoms, 
as indexed by the British Menopause Society (2016), as well as emotional reactions. The original DRK was 
developed to measure emotional distress of women undergoing IVF waiting periods, thus valid and statistically 
reliable facets of the DRK have been shown to effectively track changes in emotions related to depression, 
anxiety, anger, uncertainty, and positive affect (Boivin, 1997). Whilst the majority of these emotions are highly 
relevant to midlife women, the present study also includes emotions associated with loneliness. This is because 
feelings of loneliness have frequently been reported among menopausal women (Bingol et al., 2019). The 
menopause is considered by some to be a taboo subject, leading many to undertake the burden of their 
symptoms alone; this stoic resolve can make many women feel isolated and disconnected from friends, family 
members, and their partners. Research has explored the influence loneliness has on menopausal symptoms, and 
these studies have reported strong, negative associations, suggesting that loneliness can worsen the felt 
experience of physical symptoms (Thurston et al., 2008; Fernández et al., 2012; Hu et al., 2017; Bingol et al., 
2019).   

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Therefore, the present study will include items from previously validated measures of loneliness. The following 
emotional facets of loneliness will be included on the DRK: Isolated (as included in the UCLA loneliness scale), 
Rejected (as included in the De Jong Gierveld Scale), Lonely (as included in the direct measure of loneliness), 
Left out (as included UCLA loneliness scale). Cronbach’s analyses will be conducted on these emotional facets 
to evaluate their reliability as a brief, daily, measure of loneliness.  
 
In September 2020, the study was piloted by one woman who met eligibility criteria, completed the research 
materials and engaged in the 2- week symptom monitoring intervention. The DRK asks respondents to rate 
their emotions and symptoms from 0= Not at all (you have not experienced this symptom in the past 24 
hours), 1= Mild (you have experienced this symptom but it does not interfere with you daily activities), 2= 
Moderate (you have experienced this symptom and it interferes with your daily activities to some degree), 3= 
Severe (you have experienced this symptom and it has had a markedly negative affect on how well you have 
performed your daily tasks). The pilot participant advised that they were not sure what to do when rating 
positive emotions such as happy or content as the instructions seemed inappropriate. Therefore, the wording 
on the DRK was amended to: 0= Not at all (you have not experienced this symptom or emotion at all in the 
past 24 hours) , 1= Mild (you’ve experienced this symptom or emotion but it has not impacted your daily 
activities or made you feel any different than usual) , 2= Moderate (you’ve experienced this symptom or 
emotion and it has impacted your daily activities to some degree or made you feel somewhat different than 
usual) , 3= Severe (you’ve experienced this symptom or emotion and it has heavily impacted your daily 
activities or made you feel extremely different than usual). 
See Appendix 4 to view the daily monitoring survey which will be administered to intervention group 
participants for 14 days. See Appendix 1, page 10 to view the DRK as it will be presented on the baseline 
survey. See Appendix 3, page 7 to view the DRK as it will be presented on the follow-up survey.  See 
Appendix 10, page 11 to view an original copy of the DRK.  
 
Follow up: 
 
The measures described above will be completed again at follow-up: 
 
• 
The General help seeking questionnaire (GHSQ) 
 
• 
Health anxiety (HA) subscale extracted from The Health Orientation Scale (HOS) 
 
• 
The Willingness to Communicate about Health (WTCH) Measure 
 
• 
The Decision Self-Efficacy Scale (DSE) 
 
• 
The General Self Efficacy Scale (GSE) 
 
• 
Health Consciousness (HC) subscale extracted from The Health Orientation Scale (HOS) 
 
• 
The Daily record Keeping form (DRK) 
 
• 
Perceived effects of research engagement: Three items (to be completed after the 2-week research 
period) will assess whether research participation has led to any perceived improvements in emotional 
and physical well-being: “Since your engagement in this research, what changes have you noticed in 
your physical or emotional well-being? “If you have experienced any changes, why do you think these 
changes occurred?” and “what impact has participating in this research had on your physical or 
emotional well-being?”. These items will allow for more specific assumptions to be made about 
whether the use of symptom monitoring in research is attributed to perceived improvements, and 
whether researchers employing symptom monitoring as a control intervention should be wary of this 
occurrence. To view how the research engagement questions will be presented on the follow-up 

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survey, see Appendix 3, page 8.  
 
• 
Covid-19 experience question: A final qualitative item will also be used to assess participants’ 
experiences in dealing with the menopause during the Covid-19 pandemic: “Experiencing the 
menopause during the Covid-19 pandemic might be especially challenging for some women. Please use 
this space to tell us more about this experience if you wish. E.g., did you feel able to consult a GP when 
you needed to? Did any changes due to work restrictions or changes in home circumstances feel 
different because of the menopause? Did the menopause make you feel more or less able to cope?”. 
This item was included in order to gain perspective on the wider context in which this research is taking 
place, in order to understand how the 2020 pandemic has impacted research findings. To view the 
Covid-19 experience question as it will be presented on the follow-up survey, see Appendix 3, page 
8.  
 
 
10. PARTICIPANTS 
Discuss the number of participants required, from where the participants will be recruited, and the exclusion 
and inclusion criteria. Please include power calculations where applicable. 
 
Participants will be recruited using a research poster which will be presented both on JISC’s research 
participant finder service: www.callforparticipants.com and social media sites: Facebook, Instagram and 
Twitter. See Appendix 7 to view the recruitment poster as presented on www.callforparticipants.com, 
and shared on social media sites. All participants who meet eligibility criteria and research terms will be 
provided with a £20 Amazon voucher after completing the study to thank them for their time.  
Participants will be randomised using online resource: www.randomizer.org. Randomizer is a free resource 
for researchers in need of a quick way to generate random numbers or assign participants to experimental 
conditions. This site can be used for a variety of purposes, including psychology experiments, medical trials, 
and survey research. Randomizer works by generating a series of random unique numbers, therefore to 
allocate participants into the intervention group 1 set of 39 random numbers were generated using values 
ranging from 1-78. These figures were chosen following insights from the power analysis (see below).  
Random number generation will be used to allocate participants into groups. Participants will be assigned 
a number when they join the study by submitting the baseline survey- this number will reflect the order in 
which they joined the study i.e. the first person to join will be assigned as number 1, the second will be 
assigned as number 2. This number will determine whether they are in the control or intervention group by 
using random numbers generated by randomizer.com. Randomizer works by generating a series of random 
unique numbers, therefore, to allocate participants into the intervention group, 1 set of 39 random numbers 
will be generated using values ranging from 1-78. If the participant’s assigned number matches one of the 
39 random numbers generated, they will be allocated into the intervention group. If their number is not on 
the random number list, they will be allocated into the control group.  
 
Inclusion criteria: this study will involve adult females, who report at least 2 hot flushes per day, with self-
reported peri- or post-menopausal status. Women taking menopause-specific treatments (e.g. HRT or anti-
depressants) are included in this study provided they reach the criteria for hot flushes and are otherwise 
healthy.   
 
Exclusion criteria: participants will be screened out of the survey if they answer no to the following 
questions, which will be presented before the information sheet, consent form and main survey: “Are you 
over the age of 18?”, “Are you experiencing at least 2 hot flushes per day?”, and “Are you experiencing 
either perimenopause or menopause?”.  
 
Additionally, care will be taken to identify and exclude outliers from analyses, especially when considering 
the data of those who say they have been diagnosed with chronic or severe conditions with symptoms 
overlapping with menopausal symptoms, including chronic fatigue syndrome, fibromyalgia, cancer, heart 

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disease, thyroid disorders, depression and other mental illnesses. As the research team is not medically 
trained, we are not able to ascertain definitively if women do have any medical conditions. However, 
women will be informed in the information sheet that they should not participate if they have these 
conditions for the reason stated above, and those who report such conditions in the demographic and 
medical history will be statistically assessed with caution using univariate and multivariate analyses, and 
data from these individuals will be excluded where necessary. Participants who do not complete all study 
materials or comply fully with the experimental protocol will also be excluded from analyses. Participants 
who report demographic characteristics that have been related to poorer health will also be assessed as 
covariates. Differences in symptoms between groups according to employment status, living status and 
relationship status will be analysed to understand variances in health between these groups. This is because 
unemployed, or single, or individuals who live alone are more likely to report poorer health than others.  
 
Power analysis: 
 
An a priori power analysis was conducted using G*Power 3 (Faul, Erdfelder, Lang, & Buchner, 2007) to test 
the difference between two independent group means (accounting for special, main effects, and 
interactions) using a two-tailed test, a medium effect size (d = .40) and an alpha of .05. Results suggested 
that a total sample of 52 participants with two equal sized groups of 26 was required to achieve a power of 
.80.  
 
Medium effect sizes were estimated based on Cohen’s (1962) conventional values because these values 
were derived from studies specific to psychological research (Aguinis, & Harden, 2009). Furthermore, 
medium effect estimates, rather than small estimates, were used for this research because this study is 
exploratory and small effects on symptom frequency might not be noticeable to participants. Small effects 
might imply that symptom monitoring as an intervention to help reduce menopausal symptoms may lack 
meaningful benefit.  
 
Hoerger (2010) found evidence that at least 10% of participants will drop out of internet mediated research 
and such studies have high attrition rates. Furthermore, several studies have provided data on attrition 
rates of studies which employ a 2-week intervention period. Lancastle and Boivin’s (2008) feasibility study 
aimed to establish whether a brief coping intervention (positive reappraisal coping intervention; PRCI) was 
acceptable and practical when evaluated in the context of a randomised trial. Of the 84 women who agreed 
to participate in the study 55 (65.5%) completed all measures, suggesting an attrition rate of 34.5%. 
Moreover, Lancastle’s (2006) study also evaluated the PRCI alongside a positive mood inductive 
intervention, and a daily monitoring control group; this research reported a 31% attrition rate.  
 
Therefore, taking into account average attrition rates from internet mediated research (10%), as well as 
studies which have utilised a 2-week intervention period (33%), it was decided that the proposed study will 
use a total sample of 78 participants with two equal groups of 39.  
 
11. HAVE NATIONALLY APPROVED / REGULATORY BODY GUIDELINES BEEN FOLLOWED IN PREPARING THIS 
PROTOCOL?  
(E.g. Association of the British Pharmaceutical Industry Guidelines (1983), Royal College of Physicians 
Guidelines, The Declaration of Helsinki, British Psychological Society guidelines, BERA, etc.). If so, please 
specify. 
 
• 
Faculty of Life Sciences and Education Ethics Committee  
 
• 
GDPR regulations (2018) and the Data Protection Act (2018) 
 
• 
USW postgraduate researchers (PGR) code of practice  
 

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• 
British Psychology Society Code of Ethics for Research with Human Participants 
 
 
12. HAVE POTENTIAL PARTICIPANTS BEEN INVOLVED IN, PLEASE INDICATE. IF NO, PLEASE INDICATE WHY.  
 
 
YES 
THE DESIGN OF THIS STUDY 
 
One individual who matches the eligibility criteria has piloted this study, 
including completing all of the research materials and engaging in the 2- 
week symptom monitoring intervention. This was done to assess the 
practicality of delivering research materials and research interventions 
online, in order to highlight potential issues and identify best ways of 
working. These were the steps taken to pilot this study: 
  
1. The baseline survey link was sent to the pilot participant. 
2. Once the baseline survey was returned completed, emails were 
scheduled in advance to be sent out at set times and dates. 
3. The first email was scheduled to be sent 24 hours after the 
baseline survey had been completed- it included the pilot’s 
designated username, the pilot’s group allocation (intervention 
group), full study instructions, the link to the first daily DRK 
survey (with the instruction that it is to be completed within 24 
hours), terms and conditions for claiming the £20 voucher, and 
details on how to withdraw or opt out of receiving daily text 
message reminders. See Appendix 6, page 1 for the email 
template.  
4. The daily DRK reminder emails were scheduled to be sent each 
day for the next 13 days exactly 24 hours after the first email 
was sent. These emails included the pilot’s designated 
username, a link to the DRK survey (with the instruction that it 
is to be completed within 24 hours), terms and conditions for 
claiming the £20 voucher, and details on how to withdraw or 
opt out of receiving text message reminders. See Appendix 5, 
page 1 for the daily DRK email reminders. Because a text 
message management system was not purchased during the 
pilot study period, text message reminders were sent from 
Robin’s personal phone to the pilot participant each day (this 
individual is a close personal friend of Robin’s who already has 
her telephone number). These reminders included a link to the 
survey and advice on how to opt out of text message 
reminders (by emailing Robin). See Appendix 5, page 2 to view 
the text message reminder template.  
5. On the 15th day, scheduled exactly 24 hours after the final daily 
DRK email was sent, the follow-up survey email was sent. This 
email included the pilot’s designated username, the link to the 
follow-up survey (with the instructions that it must be 
completed within 24 hours), and advice that the £20 Amazon 
voucher will be sent once the completed follow-up survey is 
received and all other terms and conditions have been met (I.e. 
all surveys have been completed within the specified time 
frames). See Appendix 6, page 3 to view the follow-up survey 
template. 
 

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Once this user had piloted the research materials, they were asked to 
provide their opinion on the design of the study, the consent form 
items, the delivery of the data collection tools and information, as well 
as their thoughts on the data collection surveys. They confirmed that 
the surveys and the accompanying materials (i.e. the information sheet, 
debrief forms, and consent form) were easy to comprehend and 
complete. However, this participant advised that they were not sure 
what to do when rating positive emotions using the DRK, such as happy 
or content. This individual stated they did not have any problems with 
the length of time the surveys took to complete, with the baseline and 
follow-up surveys taking them “no more than half an hour each” and 
the daily DRK taking them “no more than 5 minutes each day”. The DRK 
was amended in light of these comments (for more information (see 
above and Appendix 4 to view the amended daily record keeping form).  
This individual also stated that they did not find completing the DRK 
each day for 14 days intrusive and in fact found it beneficial, and that 
the daily text reminders were especially useful for keeping track of 
when surveys needed to be completed. This individual recommended 
that text message reminders be sent out later in the day rather than at 
the same time as the survey emails, as people may be settling down 
towards the end of the day and therefore may benefit more from a later 
reminder to complete the survey. They also recommended it be made 
clear from the text messages when the surveys need to be completed 
by (i.e. “please complete the survey by 10am tomorrow morning). 
These suggestions were incorporated into the design of this study. This 
participant will be compensated with a £20 Amazon voucher for their 
time. 
 
 
INFORMED CONSENT 
DOCUMENTS 
 
As above. 
DATA COLLECTION TOOLS 
 
As above.  
 
13. DATA COLLECTION TOOLS  
Have you tested the data collection tool(s) for face validity? Where more than one tool is being utilised 
please fill in the table. 
 
 
 
 
YES, NO  
 
NA (ALL tools are already validated) 
 
Title of DCT  
Validated by you? (Y / N 
/ NA - already validated) 
Is permission 
necessary? 
Do you have permission? 
(Supply permission 
separately) 
Demographics and 
medical history (to 
be assessed at 
baseline only).   
Y 
NA 
NA 
Miller Behavioural 
Style Scale (MBSS; to 
be assessed at 
baseline only).  
NA 
Y 
Y (see Appendix 
11, page 1) 

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The neuroticism 
scale (10 items; α = 
.86) compiled from 
the International 
Personality Item 
Pool (to be assessed 
at baseline only). 
NA 
N 
NA 
General help seeking 
questionnaire 
(GHSQ; to be 
assessed at baseline 
and follow-up).  
NA 
Y 
Y (see Appendix 
11, page 3) 
Health anxiety 
subscale adapted 
from The Health 
Orientation Scale 
(HOS; to be assessed 
at baseline and 
follow-up).   
NA 
N 
NA 
Patient-doctor 
communication will 
be assessed using 
the Willingness to 
Communicate about 
Health Measure 
(WTCH; to be 
assessed at baseline 
and follow-up). 
NA 
Y 
        Y (See Appendix 11, 
page 4) 
The Decision Self-
Efficacy Scale (to be 
assessed at baseline 
and follow-up).  
NA 
N 
NA 
The General Self 
Efficacy Scale (GSE; 
to be assessed at 
baseline and follow-
up). 
NA 
NA 
NA 
Health 
Consciousness 
subscale adapted 
from The Health 
Orientation Scale 
(HOS; to be assessed 
at baseline and 
follow-up). 
NA 
N 
NA 
Two qualitative 
items (to be 
assessed at 2 weeks 
only) will assess 
whether research 
participation has led 
to improvements in 
Y 
NA 
NA 

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emotional and 
physical well-being: 
“Since your 
engagement in this 
research, what 
changes have you 
noticed in your 
physical or 
emotional well-
being? “If you have 
experienced any 
changes, why do you 
think these changes 
occurred?” 
  
  
Daily record keeping 
form (DRK). For 
participants in the 
intervention group, 
they will continually 
fill out the DRK each 
day throughout the 
2-week research 
period- whereas the 
control group will 
complete this form 
at baseline and at 2 
weeks only.  
  
NA 
Y 
Y (see Appendix 
11, page 5) 
 
 
 
PART B 
N.B. All questions should be addressed (e.g. provide an answer or state why not 
applicable). 
 
 
14. POTENTIAL RISKS AND BURDENS 
Describe potential risks and burdens for your participants. Include any potential for distress, discomfort, 
with an explanation of why it is necessary. For any risk stated here please state what will be done to 
minimise such effects. 
 
No physical risks from completing this research are anticipated, although participants may be alerted to 
issues with their physical or mental health through reflecting on their symptoms. Potential participants will 
be advised on the information sheet (see Appendix 8) that no diagnosis of physical or mental health 
problems can be made by the research team so that if they are concerned about their physical health or 
psychological well-being through taking part in the study, they should contact their GP or contact sources 
of advice and support provided on the information sheet (Appendix 8) and debrief sheets, see Appendix 
12, page 1 for debrief sheet presented at the end of the baseline survey, see Appendix 12, page 5 to see 
the debrief sheet presented at the end of the daily DRK survey, see Appendix 12, page 9 to see the debrief 

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sheet presented at the end of the follow-up survey.  Should data suggest that the DRK has a negative 
impact on some individuals, Robin’s supervisors: Dr Deborah Lancastle and Professor Bev John, will be 
consulted in the first instance, and a joint decision will be made about the best way to solve the problem, 
with escalation to the USW research governance officer, Mr Jonathan Sinfield, if this isn't solved 
satisfactorily. 
 
Although research participation will not be anonymous, as interested participants will provide their email 
addresses to the lead researcher via the baseline survey (which will be advertised on 
www.callforparticipants.com) participants will be assured that their responses to the research materials will 
be kept entirely confidential. Participants will be made aware that they cannot be identified in any write up, 
presentation or publication of results of the study. If participants are uncomfortable with sharing such 
information, they will be reassured that they do not have to take part, and that if they change their mind 
about their participation, they can close down the survey at any point before submission and any 
information collected will be deleted or destroyed. This information will be reiterated on the information 
(Appendix 8) and debrief sheets provided at the beginning and end of the research surveys (see Appendix 
12).  
 
Survey participants will be asked to provide sensitive data (i.e. email addresses, menopausal status, 
menopausal symptoms, date of last menstrual period), and they will be advised of this via the information 
sheet (See Appendix 8) that sensitive information (and the type of sensitive information) will be asked of 
them prior to taking part in the study. Participants will be advised that they can withdraw their data from 
the study at any point up until they receive their £20 Amazon incentive.  
 
To withdraw, participants will be instructed to email Robin with confirmation that they wish to withdraw 
their data. This information will be included in the information sheet (Appendix 8) and repeated in the 
debrief sheets (see Appendix 12). On the consent form (Appendix 9) participants will be asked to confirm 
that they understand they can withdraw their data up until they receive their incentive.  
 
The information sheet will also state that if participants drop out of the study, the information they have 
submitted up until that point will be retained unless the participant withdraws prior to data analyses. 
Potential participants will be notified of their rights to withdraw their data, and that data will be retained if 
they do not give notice of their withdrawal, using this using the following statement:  
 
“If you change your mind about taking part while you are still completing the survey, close down the survey 
by clicking the x in the corner of the screen and all information provided by you will be removed and 
destroyed.  To withdraw after submitting the survey, email Robin Andrews. You do not have to give a reason 
for withdrawing your data, and all your responses to every survey you have completed will be deleted. 
Please bear in mind, if you do withdraw your data it will no longer be possible for us to provide you with a 
£20 Amazon voucher and that once you have received your voucher it is no longer possible to withdraw. If 
you don’t notify Robin Andrews that you wish to withdraw, all your data will be retained in the study, so it 
is important to let Robin know if you have chosen to withdraw”. 
 
 
15. DISCLOSURE OF INFORMATION FROM INTERVIEW/QUESTIONNAIRE 
Where research might lead to unexpected disclosure of information by participants that could require 
notification or other follow up action by the researcher, how will this be handled? This provision should also 
be explained clearly within the participant information sheet. This must be handled in accordance with the 
Data Protection Acts 1998 and 2018 (DPA), as well as the new General Data Protection Regulations (GDPR). 
 
This study requires the lead researcher (RA) to contact participants regularly via email. Contact details of 
interested participants will be provided by www.callforparticipants.com.  
 

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There is a small risk that participants may use this mode of communication to consult Robin for help for 
physical or mental health problems, or they may disclose information which may require notification or follow 
up. To mitigate these risks, Robin will use a separate email address (theresearchteam@southwales.ac.uk) 
from her professional one to contact recruited participants, as agreed with USW IT. All emails sent from this 
email address will include a note at the end stating the following: “Please do not reply to this email.  If you 
would like to withdraw, please email robin.andrews@southwales.ac.uk. You can also email 
robin.andrews@southwales.ac.uk if you would like to opt out of text message reminders. If you have any 
questions or concerns about this study, please email: XXXXXXXX” It is anticipated that this instruction and 
the use of a study email address will minimise any chance of instantaneous nuisance replies to Robin. 
However, please note that Robin has not experienced any negative emails from participants in a recent 
menopause survey, so this is not anticipated in this study. The study email address will be used to advise 
recruited participants of their group allocation, their unique username, and provide further instructions (see 
Appendix 6). This email address will also be used to email a link to the DRK intervention to intervention group 
participants each day of the intervention period (see Appendix 5 to view DRK link email template), as well as 
a link to the follow-up survey to all participants (see Appendix 6).  
Robin’s personal USW email address will be provided on the information sheet (Appendix 8) and debrief forms 
(see Appendix 12) should participants have questions about the mechanics of completing the survey, it will be 
made clear on both forms that participants should only contact Robin’s email address for this purpose. If 
participants have any questions about anything else related to the survey such as the menopause, or concerns 
about the study, they will be directed to the Director of Studies (Dr Deborah Lancastle) in the first instance. If 
participants have concerns or complaints that cannot be answered satisfactorily by Deborah on consultation 
with the wider research team then the issue will be referred to the research governance officer: Jon Sinfield. 
These contact details will be provided on the information and debrief sheets. It will also clearly be stated in the 
information sheet that the research team cannot provide medical advice and that any respondents who are 
concerned should contact their GP, and examples of help sources are made available to participants on the 
information and debrief sheets:  
 
“Please note that we are not able to diagnose any physical or mental health problem from your responses to 
this survey. If you are at all concerned about your physical or mental health you should contact your own General 
Practitioner (GP) and/or other sources of help. We have provided some examples of help sources below.   
 
“You may find the following sites helpful for information about the menopause and mental health problems:  
NHS website: https://www.nhs.uk/conditions/menopause/  
British Menopause Society: https://thebms.org.uk/    
Samaritans: https://www.samaritans.org/.”                                                                                                               
 
If a participant does disclose information that requires follow-up, then Robin will consult with her supervisors 
DL and BJ who will decide on what action should be taken. Any information shared with Robin will be kept 
confidential and will be handled in accordance with the Data Protection Act 2018, as well as the new General 
Data Protection Regulations (GDPR, 2018). See Appendix 8 information sheet for the following statement: “All 
personal data (sensitive and standard) will be collected, retained and stored in accordance with the Data 
Protection Act (2018) and the General Data Protection Regulations (GDPR, 2018).”  See Appendices 13 and 14 
to view the researcher safety protocol and the risk assessment table to view more information on how 
potential risks to the researcher and research participants are being mitigated.                          
 
 
16. POTENTIAL RISKS TO THE RESEARCHER 
Describe any potential risks to the safety and wellbeing of the researcher, such as lone working. Describe 
the measures proposed to address such concerns. Have the procedures been risk assessed in accordance 
with USW guidance? 
 
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contact recruited participants. All emails sent from this address will include a note at the end stating the 
following: “Please do not reply to this email.  If you would like to withdraw, please email 
robin.andrews@southwales.ac.uk. You can also email robin.andrews@southwales.ac.uk if you would like 
to opt out of text message reminders. If you have any questions or concerns about this study, please email: 
XXXXXX”. These methods will mitigate risks of a dialogue emerging between Robin and the participants, as 
replies to the no reply email address will not reach Robin. Participants will have to make active efforts to 
communicate with Robin by composing an email to a new address, which may discourage them from 
contacting her instantly without consideration. Because participants are directed to DL and BJ for any 
queries or concerns, the chance of Robin receiving distressing emails are reduced.  
Robin will provide her official USW email address (robin.andrews@southwales.ac.uk) on the information 
and debrief sheets for participants to contact her for more information about the study, should they wish. 
This could mean that Robin may be approached by participants wishing to complain and pressurise her into 
providing remuneration for which they are not eligible, and she could be asked for advice she is not qualified 
to give. Such challenging communications put Robin at risk of worry and distress. The information sheet will 
direct participants to only contact Robin with questions about the mechanics of completing the survey. If 
participants have any questions about anything else related to the survey such as the menopause, or 
concerns about the study, they will be directed to the Director of Studies (Dr Deborah Lancastle) in the first 
instance. If participants have concerns or complaints that cannot be answered satisfactorily by Deborah on 
consultation with the wider research team then the issue will be referred to Jon Sinfield.  
 
It will also be clearly stated in the information sheet that the research team cannot provide medical advice 
and that any respondents who are concerned should contact their GP.  
 
In terms of complaints about eligibility for claiming the voucher, eligibility criteria will be clearly stated and 
repeated on the recruitment poster (see Appendix 7) presented by www.callforparticipants.com and on 
social media sites, and the information sheet (Appendix 8), minimising the likelihood that participants could 
state that they didn’t know they had to satisfy certain criteria to be eligible for study participation and thus 
remuneration. Together, these controls should minimise any chance of Robin experiencing negative 
consequences from any potential issues an individual might have with the research. See Appendix 13 for 
the researcher safety protocol, which provides detailed procedures for action, should problems arise. See 
Appendix 14 for the risk assessment table, which summarises all potential risks to the research team and 
participants, including current practices in place to reduce said risks.  
 
17. SCREENING OF IDENTIFIABLE PERSONAL INFORMATION 
Give details of the sources (e.g. patient notes) of identifiable personal information that will be used to 
identify potential participants.  
 
A recruitment poster (see Appendix 7) will be hosted on the JISC platform www.callforparticipants.com and 
social media accounts on Facebook, Twitter and Instagram. This poster will aim to attract potential 
participants and it will describe the nature of the study, including the eligibility criteria and details of what 
might be required of participants. The research team will not have direct contact with potential participants, 
as this will be facilitated by the JISC platform www.callforparticipants.com or verified USW/ KESS social 
media accounts. Once JISC has identified potential participants from their participant pool (which 
encompasses individuals who have given permission to be contacted about research participation by 
researchers), JISC will send these participants the baseline survey which will also encompass screening 
questions, the information sheet, and consent form. These individuals will be asked to provide their email 
address on the baseline survey (see Appendix 1). Those who complete baseline questionnaires will be 
emailed by the research team with details of their group allocation and further instruction.  
 
18. ADVERTISEMENTS 
All advertising material intended to recruit research participants must be reviewed by the Faculty ethics sub 
group. This includes but is not limited to: posters, letters, web pages and radio/TV broadcasts. 

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Are you intending to use any advertisements?    
            YES                   
 
If yes, please list the documents appended to this application. 
 
Appendix 7: Online recruitment poster as presented by JISC platform www.callforparticipants.com and 
social media accounts on Facebook, Twitter and Instagram. 
 
19. APPROACHING PARTICIPANTS 
Describe how potential participants will be approached and who will be involved. 
In a clinical context, patients should be initially approached by a member of their clinical care team. 
 
Copies of documentation used to approach potential participants should be enclosed with this application, 
such as a copy of the participant information sheet. 
 
A recruitment poster (see Appendix 7) will be hosted on the JISC platform www.callforparticipants.com to 
attract potential participants and it will describe the nature of the study, including the eligibility criteria and 
a brief outline of the tasks to be completed. The research team will not have direct contact with potential 
participants, as this will be facilitated by the JISC platform www.callforparticipants.com. Once JISC has 
identified potential participants from their participant pool (which encompasses individuals who have given 
permission to be contacted about research participation by researchers), JISC will send these participants 
the baseline survey which will also encompass screening questions, the information sheet, and consent 
form. These individuals will be asked to provide their email address on the baseline survey (see Appendix 
1). Those who complete baseline questionnaires will be emailed by the research team with details of their 
group allocation, their unique username, and further instruction (see Appendix 6 to view instruction email 
templates). This study will recruit participants on a rolling basis; therefore, participants will continuously be 
recruited until the required sample size has been reached. Therefore the 15-day study period will begin 
once the individual participant has submitted their baseline survey, which will be accessed via the research 
poster which will be advertised to potential participants from the point of obtaining ethical approval up 
until the required sample size has been recruited.  
 
Participants who have confirmed their interest by completing the baseline measures and the accompanying 
consent form will be emailed from the USW email address (theresearchteam@southwales.ac.uk) specific to 
this study with further instructions. Individuals allocated into the intervention group will be advised that 
they will be emailed links to complete the DRK each day for 14 days and receive text reminders (should they 
have opted in to this and provided their mobile number in the baseline survey), those allocated into the 
control group will be advised that they will be contacted by in 14 days' time, when they will be asked to 
complete a follow-up questionnaire. See Appendix 6, page 1 to view intervention group instruction email 
template, see Appendix 6, page 2 to view control group instruction email template. 
 
 
20. INFORMED CONSENT 
Describe the arrangements for taking consent from research participants prior to their participation in the 
research study. Describe the time allowed to decide to take part. Please include a copy of a written consent 
sheet (where used) with this application. 
 
For consent to be ethical and valid in law participants must be ‘capable’ of giving consent. Please ensure you 
have adhered to current guidance on the attributes of a capable person and adhered to such guidance in 
your recruitment strategy. 
 
The consent form will be included in the baseline survey (view the consent form as it will be presented on 
the online baseline survey via this link: https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-

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preview, see Appendix 9 for the consent form only). This consent form will ask participants to confirm that 
they understand the information sheet provided to them, that they are aware of what the study involves 
and that they consent to take part in the online study. Participants will be advised to take as long as they 
wish to decide, with the proviso that data analyses will commence in December 2020, so after this date the 
survey will be closed.  
 
21. INFORMED CONSENT TOOLS  
Please confirm the information sheet and consent form have been considered as appropriate for the target 
audience? 
 
 
 
 
YES             
 
The information sheet and consent form have been piloted by someone known personally to RA who meets 
the criteria for this study. They have confirmed that all aspects of the survey (including the information 
sheet and consent items) are easy to understand and interpret. Additionally, these items have been 
rigorously reviewed by supervisors DL and BJ who have extensive experience developing research studies. 
The other measures have been used in several previous peer-reviewed and published studies.  
See Appendix 8 for the survey information sheet. See Appendix 9 to view the informed consent items. 
Use this link: https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-preview to view the full 
baseline survey, which also includes the information sheet and consent form and initial screening 
questions.  
 
 
22. DATA ANALYSIS / STATISTICS 
Please describe the arrangements for analysing your data (qualitative and quantitative). Where appropriate 
discuss what data/statistical analysis will be completed. Where used, please remember to discuss sample 
size and how the sample size was decided upon.  
 
2 x 2 mixed between-within ANOVA: 
 
The main analysis will include a 2x2 mixed between-within ANOVA to assess differences in symptoms among 
the symptom monitoring and control groups before and after the 2-week research period. The between-
subjects component will encompass the differences in symptoms between the control and intervention 
groups; the within-subjects variable refers to differences in symptoms before and after the 2-week study 
period. It is expected that after 2 weeks of symptom monitoring the intervention group will exhibit a greater 
reduction in symptoms in comparison to the control group (I.e., a significant group x time interaction). As 
discussed, a power analysis was calculated to identify the minimum sample size needed to detect moderate 
effects, resulting in the decision to recruit 78 participants, with 39 participants being randomised into each 
group. 
 
Regressions:  
 
Multiple regressions will explore whether help-seeking intentions as continuous variables as predicted by 
symptom monitoring group (dummy coded), self-efficacy in patient-doctor communication, self-efficacy in 
shared decision making, health and symptom awareness, and self-efficacy in goal orientated behaviour, 
health anxiety, and menopausal symptom changes.  
 
Logistic regressions will establish whether control or intervention group membership (as measured as a 
dichotomous “Invention/Control” variable) is predicted by health anxiety, variances in emotions and 
symptoms, help-seeking intentions, self-efficacy in patient-doctor communication, self-efficacy in shared 
decision making, health and symptom awareness, and self-efficacy in goal orientated behaviour. 
 
Correlations: 

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Correlations will also be computed to assess for associations between certain variables. For example, higher 
neuroticism X higher negative emotions.  
 
  
23. DATA CUSTODIAN 
Please identify the person who is responsible for overall data security. 
 
Dr Deborah Lancastle  
 
24. DATA MANAGEMENT  
Please describe how research data will be stored, including the location and arrangements for data storage. 
Describe where/how your data will be securely stored during, and after the research study has completed. 
Describe how long data will be retained, and at what point will data be anonymised. Personal data should 
be discarded as soon as it is no longer needed.  
 
All online data provided, and databases compiled, will be kept on password protected computers which 
only the researchers and supervisors can access. The email addresses of interested participants will be 
collected on the baseline survey. All email addresses will be stored separately from survey responses on 
password protected Excel documents, and will only be accessible to Robin and her supervisors. 
 
To enable participants to withdraw their data should they wish, and ensure that personally identifiable 
information is not stored alongside responses to the intervention and follow-up materials, recruited 
participants will be provided with a unique username by email (i.e. ’Your username is: Participant1 please 
retain this information as you will be asked to confirm it on all surveys you complete’) which they will be 
asked to confirm at the beginning of each research material they complete (i.e. the DRK surveys and the 
follow-up survey).  
 
Should participants wish to withdraw their data from the study (before the data gets analysed) they will be 
instructed to email Robin confirming their decision to withdraw their data. The information sheet, consent 
from, and debrief sheets will all advise participants that their data can be removed provided they email 
Robin with confirmation of their desire to withdraw. Reminders on how to withdraw will be included on all 
emails sent to participants (see Appendix 6 to view the instruction email templates and the follow-up 
survey email template, see Appendix 5 to view daily DRK reminder email template). Withdrawal 
information will be provided on the information sheet (see Appendix 8) and confirmed on the debrief sheets 
which will be provided at the end of each survey (see Appendix 12).  
 
Dr Deborah Lancastle will be the custodian of the data. The data will not be passed on to anyone outside of 
the research team and will be kept for five years and then destroyed. Should the data be required for further 
studies other than described here, approval will be sought from the appropriate ethics panel at the 
University of South Wales. See Appendices 13 (researcher safety protocol) and 14 (risk assessment) for 
further information on steps being taken to reduce risks to the participant’s privacy.  
 
 
Are the data being collected regulated by the Data Protection Act as well as the new General Data Protection 
Regulations (GDPR)? 
 
 
 
 
YES- please see Appendix 8: Information sheet which includes the following statement to participants: “All 
responses to this survey will be confidential and secure. All personal data (sensitive and standard) will be 
collected, retained and stored in accordance with the Data Protection Act and the General Data Protection 
Regulations (GDPR, 2018).  All data provided will be kept on password protected computers which only the 
research team can access. Dr Deborah Lancastle will be the custodian of the data. The data will not be 

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passed on to anyone outside of the research team and will be kept for 5 years and then destroyed. Analysis 
of anonymised data will be carried out by members of the research team. Should the data be required for 
future studies, other than that described here, approval will be sought from the appropriate ethics panel at 
the University of South Wales.”   
 
Please see Appendix 9: Consent form to view an item assessing participants consent to their data being 
processed in accordance with DPA and GDPR regulations: “I consent to the processing of my personal 
information for the purposes of this research study. I understand that such information will be treated as 
confidential and will be handled in accordance with the Data Protection Act and the General Data Protection 
Regulations (GDPR) 2018 and will be destroyed after 5 years.”                       
 
 
If YES, please confirm that the data will be retained and stored in accordance with the General Data 
Protection Regulation (2018) by initialling below.  
 
Principal Investigator Initials: RA 
 
 
25. CONFIDENTIALITY OF DATA 
Describe the provision for ensuring that the confidentiality of personal data is preserved, such as a strategy 
for anonymity. 
 
Participants are not anonymous in this survey as their responses can be linked to their identity when they 
provide their email addresses on the baseline survey and cannot be anonymous because it is essential to 
link participants’ responses throughout the study. However, participants’ contributions are confidential as 
they cannot be identified in any publication or presentation of the results. Any potentially identifiable 
information provided in free text responses on the survey will be redacted.  
 
All online data provided, and databases compiled, will be kept on password protected computers which 
only the researchers and supervisors can access. All saved records of email addresses will be kept on 
password protected Excel documents which only the lead researcher and her supervisors can access.  
 
To enable participants to withdraw their data should they wish, and ensure that personally identifiable 
information is not stored alongside responses to the DRK and follow-up measures, recruited participants 
will be provided with a unique username which will be sent to them over email, and repeated in each 
subsequent email sent. At the beginning of the DRK intervention surveys and follow-up survey, participants 
will be asked to confirm the username they were provided with via email. If they forget their unique 
username, they are asked to contact Robin who will remind them of this.  
 
Dr Deborah Lancastle will be the custodian of the data. The data will not be passed on to anyone outside of 
the research team and will be kept for five years and then destroyed. Should the data be required for further 
studies other than described here, approval will be sought from the appropriate ethics panel at the 
University of South Wales. See Appendices 13 (researcher safety protocol) and 14 (risk assessment) for 
further information on steps being taken to reduce risks to the participant’s privacy.  
 
 
26. Please confirm that all participants being asked to provide personal data (sensitive and standard) will 
be told which legal basis is being cited for collecting and processing their personal information – this 
should be conveyed on the consent form and information sheet. In accordance with the new General 
Data Protection Regulations (GDPR)’ 
 

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Yes see Appendix 8 for the information sheet, and Appendix 9 for the consent form.  
 
 
27. PAYMENT TO RESEARCH PARTICIPANTS 
Please note, participants should not be paid for taking risks. Payment should not be set to a level that would 
unduly influence potential participants. Information pertaining to participant payment should be included 
on the Participant Information Sheet.  
 
Will participants be paid?                            YES                            
 
If yes, please give details. 
 
All 78 participants will receive a £20 Amazon gift voucher. The £20 Amazon voucher will be emailed to 
respondents at the end of the 2-week research period pending they fully adhere to the instructions provided 
and do not withdraw. To adhere to the research instructions, all participants must fully complete the 
baseline and follow-up measures, and intervention participants must complete the DRK monitoring form 
each day for 14 days within 24 hours of receiving the links via email. All participants must complete the 
follow-up survey within 24 hours of receiving the link via email. This information will be provided on the 
information sheet, and the consent form will include items which will obtain confirmation that participants 
are aware that they must complete the requirements of the study in order to claim their Amazon voucher.  
 
Some participants allocated into the control group may feel they would like to try the symptom monitoring 
intervention themselves. While it would be impractical to offer the exact intervention to control participants 
after the research period, a list of online symptom monitoring tools and mobile apps (e.g., Health and Her’s 
online symptom tool, Clue’s mobile app for period tracking) will be provided on the final debrief sheet which 
will be provided after the follow-up questionnaire is completed (see Appendix 12, page 9 to view the 
follow-up debrief sheet, see this link: https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-
preview to the follow-up survey which also presents the debrief sheet).  
 
28. PAYMENT TO RESEARCHER 
Describe any payment that the research team is receiving as part of carrying out this research study. 
Researcher payment should be recorded in the participant information sheet. 
 
This research is part of a KESS-2 funded PhD. 
 
 
29. CONFLICT OF INTEREST 
Describe any conflict of interest that anyone in the research team might have. 
  
 
No known conflicts of interest.  
 
 
30. ENSURING ANONYMITY OF IDENTIFIABLE DATA IN PUBLICATIONS 
Describe the provision for ensuring anonymity in any publication or publicly available output produced from 
this research study. 
 
 
The results of this study could lead to conference presentations and academic publications, and possibly to 
reports that could be used to improve information provision or access to medical care in the NHS or private 
care. No individual will be able to be identified in any dissemination of the results of the study. Any 
potentially identifiable information provided in free text responses on the survey will be redacted.  

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Because this study is part of a KESS-2 studentship, the results will be available to the company to use to 
improve their provision; however, data will be summarised as results of analyses, anonymous, and 
participants cannot be identified. Participants will be informed in the information sheet that the results may 
be used by Health & Her to improve their services.  The data will not be passed on to anyone outside of the 
research team and will be kept for five years and then destroyed. Should the data be required for further 
studies other than described here, approval will be sought from the appropriate ethics panel at the 
University of South Wales. See Appendices 13 (researcher safety protocol) and 14 (risk assessment) for 
further information on steps being taken to reduce risks to the participant’s privacy. 
 
31. SCIENTIFIC SCRUTINY AND RESOURCING 
 
Has this research study been peer reviewed?  
 
NO 
 
If YES, please provide information about the review, including the reviewing body and date of 
review/approval. 
 
NA 
 
 
32. INSURANCE INDEMNITY 
i. 
Does this research study require indemnity/insurance cover from the University of South Wales? 
 
Yes 
 
ii. 
Will the research take place on University of South Wales’ premises? 
 
 NO 
 
If NO, give details of any offsite locations: 
 
All data will be collected digitally online, analyses of data will take place off premises due to COVID-19 
restrictions.  
 
iii. DOES THE RESEARCH UTILISE ANY OF THE FOLLOWING (PLEASE INDICATE ALL THAT APPLY): No 
 
Investigating or participating in methods of contraception? 
Assisting with or altering the process of conception? 
The use of drugs? 
The use of surgery? (other than biopsy) 
Genetic engineering? 
Participants under 5 years of age? (other than activities above) 
Participants known to be pregnant? (other than activities above) 
Pharmaceutical product/appliance designed or manufactured by host institution? 
Work outside of United Kingdom? 
 
If YES to any of the above please contact the Research Governance Manager – 
jonathan.sinfield@southwales.ac.uk 
 
N/A 

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33.  
 
Security Sensitive Material 
Will your 
project involve 
any of these? 
  
NA to all 
    Ministry of Defence-commissioned work on military equipment or policy 
EU security research including policy development 
    All work related to extremist groups (e.g. related to animal rights 
campaigners) 
    IT encryption design for public bodies or businesses 
    All work related to terrorism 
 
If you respond YES to any of the above please ensure your complete and attach the USW 
PREVENT for RESEARCH registration forms to this application 
 
I have read and agree to abide by the latest version of the document:  
Research Ethics Policy, Terms of Reference and Operating Procedures for University Ethics Sub 
Group and Faculty Research Ethics Committees  
This can be found at https://www.southwales.ac.uk/research/research-expertise/research-
governance/ 
Research Governance | University of South Wales 
The University is committed to the following principles of good 
research practice. These are laid out in our USW Research Good 
Practice Code of Conduct which stipulates: That our research is 
underpinned with common values of rigour and integrity 
www.southwales.ac.uk 
 
 
• At the time of signing this application, I consider it to be complete and accurate 
 
• I will notify the faculty ethics sub group immediately if i subsequently consider the application requires any 
correction or qualification, or if there is any revision to the proposal. 
 
• I understand that I may be invited to discuss my proposal with the faculty ethics sub group. 
 
SIGNATURE OF INVESTIGATOR  
Robin Andrews 
 
 
SIGNATURE OF SUPERVISOR  
Deborah Lancastle  
DATE OF SUBMISSION 
 
 
 
 
 
 
SIGNATURE OF APPROVAL 
 
…………………………………………………... 
(Chair/Secretary – FESG) 
 
DATE OF APPROVAL 
  
.............................................................................. 
 

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Appendices 
 
Appendix 1: The baseline survey in Word document format (visit 
https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-preview to preview the 
survey on JISC Online Surveys). Page 29 
 
Appendix 2: The initial screening questions, which will be presented on Online Surveys at 
the beginning of the baseline survey before the information sheet, consent items, and 
main baseline questions. Page 41 
 
Appendix 3: The follow-up survey in Word document format (visit: 
https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-preview to preview the 
survey on JISC Online Surveys). Page 43 
 
Appendix 4: The daily DRK survey in Word document format (visit: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-form-preview to preview 
the daily DRK as it will be presented on JISC Online Surveys). Page 52 
 
Appendix 5: Templates of the text message reminders and daily DRK email reminders. 
Page 55 
 
Appendix 6: Participant information email templates. Page 56 
 
Appendix 7: The recruitment poster (as presented on www.callforparticipants.com). Page 
59 
 
Appendix 8: Information sheet. Page 60 
 
Appendix 9: Consent form. Page 68  
 
Appendix 10: Original copies of validated questionnaires. Page 69 
 
Appendix 11: Permission to use the MBSS, GHSQ, WTCH, and the DRK from lead authors. 
Page 78  
 
Appendix 12: The 3 debrief sheets. Page 83 
 
Appendix 13: The researcher safety protocol. Page 93 
 
Appendix 14: The risk assessment table. Page 98 
 
Appendix 1: The baseline survey in Word document format: 

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Baseline questionnaire 
 
Demographics: 
 
4. Please type your email address (this is required to continue with this study) 
 
………………… 
 
5. How would you describe your physical and mental health in general? 
 
❑ Good 
❑ Okay 
❑ Poor  
 
6. What is your living status? 
 
❑ I live alone 
❑ I live with my family 
❑ I live with friends 
❑ I live with my partner 
❑ I live in shared housing 
❑ I live in a residential home 
 
7. What is your relationship status? 
 
❑ In a relationship 
❑ In a relationship and living together 
❑ Married 
❑ Divorced or separated 
❑ Widowed 
❑ Single 
 
8. What is your current occupation? Tick as many as apply: 
 
❑ Working full-time 
❑ Working part-time 
❑ Student 
❑ Military 
❑ Volunteer 
❑ Looking for work 
❑ Homemaker 
❑ Retired 

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❑ Unable to work due to illness or disability 
❑ Full-time carer for a family member/ loved one 
❑ Other 
 
8b. If you selected Other, please specify: 
 
……………… 
 
9. What is your ethnicity? 
 
❑ White  
❑ Asian  
❑ Black  
❑ Mixed ethnicity  
❑ Other  
 
9a. If you selected Other, please specify: 
 
……………… 
 
10. What was the date of your last menstrual period? If you can't remember exactly please 
give your best estimate: 
 
……………… 
 
11. Please type the name of the country and the town/city you live in: 
 
……………… 
 
12. Are you currently using any medication or treatments for your menopause symptoms? 
 
❑ No  
❑ Yes 
 
12a. If you selected Yes, please specify which medication or treatments you are using. 
Examples can include HRT, antidepressants, psychological treatments, counselling, or 
supplements. 
 
……………… 
 
13. Please describe any health conditions that you are currently being treated for: 
 
……………… 

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14. Please describe any non-menopause-related medications or treatments you are 
currently using: 
 
……………… 
 
 
 
 
You are now going to be asked some questions about your health and you as a person, 
please work through them, giving the answer that best applies to you for each question. 
 
Mood questionnaire: 
 
15. Describe yourself as you generally are now, not as you wish to be in the future. Describe 
yourself as you honestly see yourself, in relation to other women of your age. Indicate for 
each statement whether it is:  
 
1= Very Inaccurate, 2= Moderately Inaccurate, 3= Neither Accurate nor Inaccurate, 4= 
Moderately Accurate, or 5= Very Accurate, as a description of you. 
 
  
1. Very 
Inaccurate 
2. Moderately 
Inaccurate 
3. Neither 
Accurate nor 
Inaccurate 
4. Moderately 
Accurate 
5. Very 
Accurate 
I often feel blue.  
 
  
  
  
I dislike myself.  
  
  
  
  
I am often down 
in the dumps. 
  
  
  
  
  
I have frequent 
mood swings. 
 
  
  
  
  
I panic easily. 
 
  
  
  
  
I rarely get 
irritated. 
  
  
  
  
  
I seldom feel 
blue. 
  
  
  
  
  
I feel 
comfortable with 
myself. 
  
  
  
  
  
I am not easily 
bothered by 
  
  
  
  
  

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things. 
I am very 
pleased with 
myself. 
  
  
  
  
 
 
 
Help Seeking questionnaire: 
 
16. If you were having a personal or emotional problem, how likely is it that you would seek 
help from the following people? Please indicate your response by selecting the number that 
best describes your intention to seek help from each help source that is listed. Use this scale 
to indicate your response: 1 = Extremely Unlikely, 3 = Unlikely, 5 = Likely, 7 = Extremely 
Likely. 
 
  
1 2 3 4 5 6 7 
Intimate partner (e.g., girlfriend, boyfriend, husband, wife etc.) 
        
  
  
  
Friend (not related to you) 
        
  
  
  
Relative/family member 
        
  
  
  
Mental health professional (e.g. psychologist, social worker, 
counsellor) 
        
  
  
  
Internet sources including health websites, online forums (i.e. 
Mumsnet, Reddit, Quora) or social media (i.e. Facebook groups, 
Twitter, Instagram)  
        
  
  
  
Phone helpline 
 
 
 
 
 
 
 
Doctor/GP  
        
  
  
  
Minister or religious leader (e.g. Priest, Rabbi, Chaplain) 
        
  
  
  
I would not seek help from anyone 
        
  
  
  
I would seek help from another not listed above 
        
  
  
 
 
16b. Who else would seek help from? Type N/A if all of your help sources have been listed 
above. 
 
……………… 
 
 
Thoughts about health questionnaire: 
 
17. Please read each item carefully and decide to what extent it is characteristic of you. Give 
each item a rating of how much it applies to you by marking your response by using the 

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following scale: 1 = Not at all characteristic of me, 2 = Slightly characteristic of me, 3 = 
Somewhat characteristic of me, 4 = Moderately characteristic of me, 5 = Very characteristic 
of me 
 
 
  
1 = Not at all 
characteristic of 
me 
2 = Slightly 
characteristic 
of me 
3 = Somewhat 
characteristic of 
me 
4 = Moderately 
characteristic of 
me 
5 = Very 
characteristic 
of me 
I feel 
anxious 
when I think 
about my 
health. 
  
  
  
  
  
I'm worried 
about how 
healthy my 
body is. 
  
  
  
  
  
Thinking 
about my 
physical 
health 
leaves me 
with an 
uneasy 
feeling. 
  
  
  
  
  
I usually 
worry about 
whether I 
am in good 
health. 
  
  
  
  
  
I feel 
nervous 
when I think 
about the 
status of my 
physical 
health. 
  
  
  
  
  
I am very 
aware of 
how healthy 
my body 
  
  
  
  
  

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feels. 
I notice 
immediately 
when my 
body 
doesn't feel 
healthy. 
  
  
  
  
  
I'm sensitive 
to internal 
bodily cues 
about my 
physical 
health. 
  
  
  
  
  
I know 
immediately 
when I'm 
not feeling 
physically 
well. 
  
  
  
  
  
I'm very 
aware of 
changes in 
my physical 
health. 
  
  
  
  
 
 
 
Health communication scale: 
 
18. Please read through the following statements and indicate how strongly you agree with 
them. 
 
  
1 = Strongly 
Disagree 
2 = Mildly 
Disagree 
3 = 
Undecided 
4 = Mildly 
Agree 
5 = Strongly 
Agree 
In general, I feel comfortable 
talking with physicians about my 
health. 
  
  
  
  
  
I usually feel relaxed when talking 
about my health problems with 
my family. 
  
  
  
  
  
I typically feel comfortable giving 
others information about my 
  
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
35 
health status. 
In general, I don’t mind discussing 
my health status with friends. 
  
  
  
  
  
I typically discuss emotional 
concerns I have about my health 
status with health providers. 
  
  
  
  
  
I usually feel awkward talking 
about my health problems with 
others. 
  
  
  
  
  
I would not have a problem talking 
to nurses about my health status.   
  
  
  
  
In general, I would not mind 
discussing my health with other 
people who have a similar health 
history. 
  
  
  
  
  
I am generally willing to engage in 
a conversation about information 
related to my health status if 
someone asks me a question 
about my condition. 
  
  
  
  
  
I would not be willing to discuss 
my fears about my health 
condition with others. 
  
  
  
  
 
 
 
Decision-making scale: 
 
19. Below are listed some things involved in making an informed choice. Please show how 
confident you feel in doing these things by circling the number from 0 (not at all confident) 
to 4 (very confident) for each item listed below. 
 
  
0 (Not at all 
confident) 
1 
2 
3 
4 (Very 
confident) 
I feel confident that I can get the facts about the 
medication choices available to me 
  
  
  
  
  
I feel confident that I can get the facts about the 
benefits of each choice 
  
  
  
  
  
I feel confident that I can get the facts about the 
risks and side effects of each choice 
  
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
36 
I feel confident that I can understand the 
information enough to be able to make a choice   
  
  
  
  
I feel confident that I can ask questions without 
feeling dumb 
  
  
  
  
  
I feel confident that I can express my concerns 
about each choice 
  
  
  
  
  
I feel confident that I can ask for advice 
  
  
  
  
  
I feel confident that I can figure out the choice 
that best suits me 
  
  
  
  
  
I feel confident that I can handle unwanted 
pressure from others in making my choice 
  
  
  
  
  
I feel confident that I can let the clinic team know 
what’s best for me 
  
  
  
  
  
I feel confident that I can delay my decision if I feel 
I need more time 
  
  
  
  
 
 
 
 
Self-efficacy scale: 
 
20. Please read through the following statements and indicate how accurately they apply to 
you: 
 
  
1 = Not at 
all true 
2 = Hardly 
true 
3 = Moderately 
true 
4 = Exactly 
true 
I can always manage to solve difficult 
problems if I try hard enough 
  
  
  
  
If someone opposes me, I can find the 
means and ways to get what I want. 
  
  
  
  
It is easy for me to stick to my aims and 
accomplish my goals. 
  
  
  
  
I am confident that I could deal efficiently 
with unexpected events. 
  
  
  
  
Thanks to my resourcefulness, I know 
how to handle unforeseen situations. 
  
  
  
  
I can solve most problems if I invest the 
necessary effort. 
  
  
  
  
I can remain calm when facing difficulties 
because I can rely on my coping abilities.   
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
37 
When I am confronted with a problem, I 
can usually find several solutions. 
  
  
  
  
If I am in trouble, I can usually think of a 
solution. 
  
  
  
  
I can usually handle whatever comes my 
way. 
  
  
  
 
 
 
 
The Daily Record Keeping Form: 
 
21. Please read through the following emotions and menopausal symptoms and indicate 
whether you have experienced them in the past 24 hours using this scale: 0= Not at all (you 
have not experienced this symptom or emotion at all in the past 24 hours) , 1= Mild 
(you’ve experienced this symptom or emotion but it has not impacted your daily activities 
or made you feel any different than usual) , 2= Moderate (you’ve experienced this 
symptom or emotion and it has impacted your daily activities to some degree or made 
you feel somewhat different than usual) , 3= Severe (you’ve experienced this symptom or 
emotion and it has heavily impacted your daily activities or made you feel extremely 
different than usual). 
 
  
0= Not at all 
1= Mild  
2= Moderate  
3= Severe  
Nervous 
 
  
  
  
Positive 
 
  
  
  
Relieved 
 
  
  
  
Sad 
 
  
  
  
Hopeful 
 
  
  
  
Confident 
 
  
  
  
Disappointed 
 
  
  
  
Hesitant 
 
 
 
 
Happy 
 
  
  
  
Doubtful 
 
 
 
 
Discouraged 
 
  
  
  
Anxious 
 
  
  
  
Isolated 
 
  
  
  
Content 
 
  
  
  
Tense 
 
  
  
  
Rejected 
 
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
38 
Fulfilled 
 
  
  
  
 Uncertain 
 
 
 
 
Left out 
 
  
  
  
Lonely 
 
  
  
  
Encouraged 
 
  
  
  
Angry 
 
  
  
  
Worried 
 
  
  
  
Unsure 
 
  
  
  
Sleeping 
problems 
 
  
  
  
Weight gain 
 
  
  
  
Joint aches 
 
  
  
  
Low energy 
 
  
  
  
Hot flushes 
 
  
  
  
Stress/ anxiety  
  
  
  
Night sweats 
 
  
  
  
Low mood 
 
  
  
  
Brain fog 
 
  
  
  
Loss of sex drive  
  
  
  
Headaches 
 
  
  
  
Period changes  
  
  
  
Skin changes 
 
  
  
  
Vaginal dryness  
  
  
  
Urinary changes  
  
  
  
Painful sex 
 
  
  
  
Bloating 
 
  
  
  
Poor 
concentration 
 
  
  
  
Itchy skin 
 
  
  
  
Digestive issues  
  
  
  
Memory loss 
 
  
  
  
Irregular 
heartbeat 
 
  
  
  
Breast pain 
 
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
39 
Brittle nails 
 
  
  
  
Hair loss 
 
  
  
  
Electric shock 
sensations 
 
  
  
  
Muscle tension  
  
  
  
Body odour 
 
  
  
  
Allergies 
 
  
  
  
Burning tongue  
  
  
  
Other 
 
  
  
 
 
21b. If you selected "other" in the question above, please type what it was (type N/A if this 
does not apply to you): 
 
……………… 
 
Health behaviour questionnaire: 
 
22. Vividly imagine that you are afraid of the dentist and have to get some dental work 
done. Which of the following would you do? Check all of the statements that might apply to 
you. 
 
❑ I would ask the dentist exactly what work was going to be done. 
❑ I would take a tranquilizer or have a drink before going. 
❑ I would try to think about pleasant memories. 
❑ I would want the dentist to tell me when I would feel pain. 
❑ I would try to sleep. 
❑ I would watch all the dentist's movements and listen for the sound of the drill. 
❑ I would watch the flow of water from my mouth to see if it contained blood. 
❑ I would do mental puzzles in my mind. 
 
23. Vividly imagine that you are being held hostage by a group of armed terrorists in a public 
building. Which of the following would you do? Check all of the statements that might apply 
to you. 
 
❑ I would sit by myself and have as many daydreams and fantasies as I could. 
❑ I would stay alert and try to keep myself from falling asleep. 
❑ I would exchange life stories with the other hostages. 
❑ If there was a radio present, I would stay near it and listen to the bulletins about 
what the 
❑ police were doing. 
❑ I would watch every movement of my captors and keep an eye on their weapons. 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
40 
❑ I would try to sleep as much as possible. 
❑ I would think about how nice it's going to be when I get home. 
❑ I would make sure I knew where every possible exit was. 
 
24. Vividly imagine that, due to a large drop in sales, it is rumoured that several people in 
your department at work will be laid off. Your supervisor has turned in an evaluation of your 
work for the past year. The decision about lay-offs has been made and will be announced in 
several days. Check all of the statements that might apply to you. 
 
❑ I would talk to my fellow workers to see if they knew anything about what the 
❑ supervisor evaluation of me said. 
❑ I would review the list of duties for my present job and try to figure out if I had 
fulfilled them 
❑ all. 
❑ I would go to the movies to take my mind off things. 
❑ I would try to remember any arguments or disagreements I might have had that 
would 
❑ have resulted in the supervisor having a lower opinion of me. 
❑ I would push all thoughts of being laid off out of my mind. 
❑ I would tell my spouse that I'd rather not discuss my chances of being laid off. 
❑ I would try to think which employees in my department the supervisor might have 
❑ thought had done the worst job. 
❑ I would continue doing my work as if nothing special was happening. 
 
25. Vividly imagine that you are on an airplane, thirty minutes from your destination, when 
the plane unexpectedly goes into a deep dive and then suddenly levels off. After a short 
time, the pilot announces that nothing is wrong, although the rest of the ride may be rough. 
You, however, are not convinced that all is well. Check all of the statements that might 
apply to you. 
 
❑ I would carefully read the information provided about safety features in the plane 
and 
❑ make sure I knew where the emergency exits were. 
❑ I would make small talk with the passenger beside me. 
❑ I would watch the end of the movie, even if I had seen it before. 
❑ I would call for the flight attendant and ask what exactly the problem was. 
❑ I would order a drink from the flight attendant or take a tranquilizer. 
❑ I would listen carefully to the engines for unusual noises and would watch the crew 
to 
❑ see if their behaviour was out of the ordinary. 
❑ I would talk to the passenger beside me about what might be wrong. 
❑ I would settle down and read a book or magazine or write a letter. 
 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
41 
26. If you are randomly assigned to the daily monitoring group, do you wish to receive text 
reminders to complete the questionnaire?  
 
❑ Yes  
❑ No 
 
26b. Please type your mobile phone number: 
 
………………… 
 
To view the baseline survey as it will be presented on JISC Online Surveys (including the 
initial screening questions, information sheet, and consent items) please use this link: 
https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-preview  
 
 
Appendix 2: The initial screening questions, which will be presented on Online Surveys at 
the beginning of the baseline survey before the information sheet, consent items, and 
main baseline questions.  
 
Appendix 2: Initial screening questions: 
 
1. Are you over the age of 18?  
 
❑ Yes  
❑ No (respondents who select this answer will be screened out of the survey)  
 
1b. If you selected yes, please type your age:   
………………  
 
2. On average, how many hot flushes and/or night sweats are you currently experiencing 
every 24 hours? Tick the answer that most applies to you.  
 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
42 
❑ I am not currently experiencing any hot flushes or night sweats (respondents 
who select this answer will be screened out of the survey).  
❑ I am experiencing fewer than 2 hot flushes and/or night sweats per day 
(respondents who select this answer will be screened out of the survey)  
❑ I am experiencing 2 hot flushes and/or night sweats per day.  
❑ I am experiencing more than 2 hot flushes and/or night sweats per day. (say 
how many)  
 
3. Which stage of the menopause best matches your current experience? Tick the answer 
which most applies to you:  
 
❑ Premenopause: I do not have menopausal symptoms yet, and I continue to 
have my periods as usual (respondents who select this answer will be 
screened out of the survey).  
❑ Perimenopause – Early Phase: I am currently experiencing menopausal 
symptoms. I have regular monthly periods, but the length or flow of each 
period varies.  
❑ Perimenopause – Late Phase: I am experiencing menopausal symptoms and 
have not gone 12 months in a row without a period, but I sometimes have 
more than 2months between periods.  
❑ Postmenopause – Symptomatic: I haven’t had my period in over 12 months, 
and continue to have menopausal symptoms.  
❑ Postmenopause – Asymptomatic: I haven’t had my period in over 12 months, 
and I no longer have (or never had) menopausal symptoms (respondents 
who select this answer will be screened out of the survey).  
 
Link to screening questions as presented at the beginning of the baseline survey (before the 
information sheet, consent form, and main survey questions): 
https://southwales.onlinesurveys.ac.uk/baseline-questionnaire-preview  
Appendix 3: The follow-up survey in Word document format (visit: 
https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-preview to preview the 
survey on JISC Online Surveys).  
Follow-up questionnaire 
 
1. Please confirm the username you were provided with by the 
research team, you will find it on the email you received 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
43 
which included the link to this survey. Please note that if 
you do not include this word, your response won’t be valid 
because we can’t match it with your earlier questionnaire 
response. This will affect your eligibility for your voucher. 
Therefore, if you are not sure of your username, please 
contact Robin Andrews at robin.andrews@southwales.ac.uk:  
 
………………… 
 
Help Seeking questionnaire: 
 
2. If you were having a personal or emotional problem, how 
likely is it that you would seek help from the following 
sources? Please indicate your response by selecting the number 
that best describes your intention to seek help from each help 
source that is listed. Use this scale to indicate your 
response: 1 = Extremely Unlikely, 3 = Unlikely, 5 = Likely, 7 
= Extremely Likely. 
 
  
1 2 3 4 5 6 7 
Intimate partner (e.g., girlfriend, boyfriend, husband, wife etc.) 
              
Friend (not related to you) 
             
Relative/family member 
       
Mental health professional (e.g. psychologist, social worker, 
counsellor) 
       
Phone helpline 
       
Internet sources including health websites, online forums 
(Mumsnet, Quora, Reddit) and social media (I.e. Facebook groups, 
Twitter, Instagram) 
       
Doctor/GP 
       
Minister or religious leader (e.g. Priest, Rabbi, Chaplain) 
       
I would not seek help from anyone 
       
I would seek help from another not listed above 
       
 
2b. Who else would seek help from? Type N/A if all of your 
help sources have been listed above. 
 
………………… 
 
Thoughts about health questionnaire: 
 
3. Please read each item carefully and decide to what extent 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
44 
it is characteristic of you. Give each item a rating of how 
much it applies to you by marking your response by using the 
following scale: 1 = Not at all characteristic of me, 2 = 
Slightly characteristic of me, 3 = Somewhat characteristic of 
me, 4 = Moderately characteristic of me, 5 = Very 
characteristic of me 
 
 
  
1 = Not at all 
characteristic 
of me 
2 = Slightly 
characteristic 
of me 
3 = Somewhat 
characteristic 
of me 
4 = Moderately 
characteristic 
of me 
cha
I feel 
anxious 
when I 
think about 
my health. 
  
  
  
  
  
I'm worried 
about how 
healthy my 
body is. 
  
  
  
  
  
Thinking 
about my 
physical 
health 
leaves me 
with an 
uneasy 
feeling. 
  
  
  
  
  
I usually 
worry about 
whether I 
am in good 
health. 
  
  
  
  
  
I feel 
nervous 
when I 
think about 
the status 
of my 
physical 
health. 
  
  
  
  
  
I am very 
aware of 
how healthy 
  
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
45 
my body 
feels. 
I notice 
immediately 
when my 
body 
doesn't 
feel 
healthy. 
  
  
  
  
  
I'm 
sensitive 
to internal 
bodily cues 
about my 
physical 
health. 
  
  
  
  
  
I know 
immediately 
when I'm 
not feeling 
physically 
well. 
  
  
  
  
  
I'm very 
aware of 
changes in 
my physical 
health. 
  
  
  
  
 
 
 
Health communication scale: 
 
4. Please read through the following statements and indicate 
how strongly you agree with them. 
 
  
1 = 
Strongly 
Disagree 
2 = 
Mildly 
Disagree 
3 = 
Undecided 
4 = 
Mildly 
Agree 
5 = 
Strongly 
Agree 
In general, I 
feel 
comfortable 
talking with 
physicians 
about my 
health. 
  
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
46 
I usually feel 
relaxed when 
talking about 
my health 
problems with 
my family. 
  
  
  
  
  
I typically 
feel 
comfortable 
giving others 
information 
about my health 
status. 
  
  
  
  
  
In general, I 
don’t mind 
discussing my 
health status 
with friends. 
  
  
  
  
  
I typically 
discuss 
emotional 
concerns I have 
about my health 
status with 
health 
providers. 
  
  
  
  
  
I usually feel 
awkward talking 
about my health 
problems with 
others. 
  
  
  
  
  
I would not 
have a problem 
talking to 
nurses about my 
health status. 
  
  
  
  
  
In general, I 
would not mind 
discussing my 
health with 
other patients 
who have a 
similar health 
history. 
  
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
47 
I am generally 
willing to 
engage in a 
conversation 
about 
information 
related to my 
health status 
if someone asks 
me a question 
about my 
condition. 
  
  
  
  
  
I would not be 
willing to 
discuss my 
fears about my 
health 
condition with 
others. 
  
  
  
  
 
 
 
Decision-making scale: 
 
5. Below are listed some things involved in making an informed 
choice. Please show how confident you feel in doing these 
things by circling the number from 0 (not at all confident) to 
4 (very confident) for each item listed below. 
 
  
0 (Not at all 
confident) 1 2 3 
4 (Very 
confident) 
I feel confident that I can 
get the facts about the 
medication choices available 
to me 
  
        
I feel confident that I can 
get the facts about the 
benefits of each choice 
  
        
I feel confident that I can 
get the facts about the risks 
and side effects of each 
choice 
  
        
I feel confident that I can 
understand the information 
enough to be able to make a 
  
        

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
48 
choice 
I feel confident that I can 
ask questions without feeling 
dumb 
  
        
I feel confident that I can 
express my concerns about each 
choice 
  
        
I feel confident that I can 
ask for advice 
  
        
I feel confident that I can 
figure out the choice that 
best suits me 
  
        
I feel confident that I can 
handle unwanted pressure from 
others in making my choice 
  
        
I feel confident that I can 
let the clinic team know 
what’s best for me 
  
        
I feel confident that I can 
delay my decision if I feel I 
need more time 
  
       
 
Self-efficacy scale: 
 
6. Please read through the following statements and indicate 
how accurately they apply to you: 
 
  
1 = Not 
at all 
true 
2 = 
Hardly 
true 
3 = 
Moderately 
true 
4 = 
Exactly 
true 
I can always manage to solve 
difficult problems if I try 
hard enough 
  
  
  
  
If someone opposes me, I can 
find the means and ways to 
get what I want. 
  
  
  
  
It is easy for me to stick 
to my aims and accomplish my 
goals. 
  
  
  
  
I am confident that I could 
deal efficiently with 
unexpected events. 
  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
49 
Thanks to my 
resourcefulness, I know how 
to handle unforeseen 
situations. 
  
  
  
  
I can solve most problems if 
I invest the necessary 
effort. 
  
  
  
  
I can remain calm when 
facing difficulties because 
I can rely on my coping 
abilities. 
  
  
  
  
When I am confronted with a 
problem, I can usually find 
several solutions. 
  
  
  
  
If I am in trouble, I can 
usually think of a solution.   
  
  
  
I can usually handle 
whatever comes my way. 
  
  
  
 
 
The Daily Record Keeping Form: 
 
7. Please read through the following emotions and menopausal 
symptoms and indicate whether you have experienced them in the 
past 24 hours using this scale: 0= Not at all (you have not experienced this 
symptom or emotion at all in the past 24 hours) , 1= Mild (you’ve experienced this 
symptom or emotion but it has not impacted your daily activities or made you feel any 
different than usual) , 2= Moderate (you’ve experienced this symptom or emotion and it 
has impacted your daily activities to some degree or made you feel somewhat different 
than usual) , 3= Severe (you’ve experienced this symptom or emotion and it has heavily 
impacted your daily activities or made you feel extremely different than usual). 
 
  
0= Not at all  
1= Mild  
2= Moderate 
3= Severe 
Nervous 
 
  
  
  
Positive 
 
  
  
  
Relieved 
 
  
  
  
Sad 
 
  
  
  
Hopeful 
 
  
  
  
Doubtful 
 
 
 
 
Confident 
 
  
  
  
Disappointed  
  
  
  
Happy 
 
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
50 
Discouraged  
  
  
  
Unsure 
 
 
 
 
Anxious 
 
  
  
  
Isolated 
 
  
  
  
Content 
 
  
  
  
Tense 
 
  
  
  
Rejected 
 
  
  
  
Fulfilled 
 
  
  
  
Hesitant 
 
 
 
 
Left out 
 
  
  
  
Lonely 
 
  
  
  
Encouraged  
  
  
  
Uncertain 
 
 
 
 
Angry 
 
  
  
  
Worried 
 
  
  
  
Sleeping 
problems 
 
  
  
  
Weight gain  
  
  
  
Joint aches  
  
  
  
Low energy  
  
  
  
Hot flushes  
  
  
  
Stress/ 
anxiety 
 
  
  
  
Night sweats  
  
  
  
Low mood 
 
  
  
  
Brain fog 
 
  
  
  
Loss of sex 
drive 
 
  
  
  
Headaches 
 
  
  
  
Period 
changes 
 
  
  
  
Skin changes  
  
  
  
Vaginal 
dryness 
 
  
  
  
Urinary 
changes 
 
  
  
  
Painful sex  
  
  
  

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
51 
Bloating 
 
  
  
  
Poor 
concentration  
  
  
  
Itchy skin  
  
  
  
Digestive 
issues 
 
  
  
  
Memory loss  
  
  
  
Irregular 
heartbeat 
 
  
  
  
Breast pain  
  
  
  
Brittle nails  
  
  
  
Hair loss 
 
  
  
  
Electric 
shock 
sensations 
 
  
  
  
Muscle 
tension 
 
  
  
  
Body odour  
  
  
  
Allergies 
 
  
  
  
Burning 
tongue 
 
  
  
  
Other 
 
  
  
 
 
7b. If you selected "other" in the question above, please type 
what it was (type n/a if this does not apply to you): 
 
………………… 
 
8. Since your engagement in this research, what changes have 
you noticed in your physical or emotional well-being? 
 
………………… 
 
8b. If you have experienced any changes, why do you think 
these changes occurred? 
 
………………… 
 
8c. What impact has participating in this research had on your 
physical or emotional well-being? 
 
………………… 

FACULTY OF LIFE SCIENCES AND EDUCATION 
FACULTY ETHICS SUB GROUP APPLICATION FORM 
 
R10 Ethics V1 
 
52 
 
9. Experiencing the menopause during the Covid-19 pandemic 
might be especially challenging for some women. Please use 
this space to tell us more about this experience if you wish. 
E.g., did you feel able to consult a GP when you needed to? 
Did any changes due to work restrictions or changes in home 
circumstances feel different because of the menopause? Did the 
menopause make you feel more or less able to cope? 
 
………………… 
 
 
To view this survey as it will be presented on JISC Online 
Surveys, please follow this link: 
https://southwales.onlinesurveys.ac.uk/follow-up-
questionnaire-preview  
 
Appendix 4: The daily DRK survey in Word document format 
 
The Daily Record Keeping Form 
 
Main DRK survey 
 
1. Please confirm the username you were provided with by the 
research team, you will find it on the email you received 
which included the link to this survey Please note that if you 
do not include this word, your response won’t be valid because 
we can’t match it with your earlier questionnaire response. 
This will affect your eligibility for your voucher. Therefore, 
if you are not sure of your username, please contact Robin 
Andrews at robin.andrews@southwales.ac.uk:  
 
………………… 
 
The Daily Record Keeping Form: 
 
3. Please read through the following emotions and menopausal 
symptoms and indicate whether you have experienced them in the 
past 24 hours using this scale: 0= Not at all (you have not 
experienced this symptom or emotion at all in the past 24 
hours) , 1= Mild (you’ve experienced this symptom or emotion 
but it has not impacted your daily activities or made you feel 
any different than usual) , 2= Moderate (you’ve experienced 
this symptom or emotion and it has impacted your daily 
activities to some degree or made you feel somewhat different 
than usual), 3= Severe (you’ve experienced this symptom or 
emotion and it has heavily impacted your daily activities or 

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made you feel extremely different than usual). 
 
  
0= Not at 
all  
1= Mild  
2= Moderate  
3= Severe  
Nervous 
 
  
  
  
Positive 
 
  
  
  
Relieved 
 
  
  
  
Sad 
 
  
  
  
Hopeful 
 
  
  
  
Confident 
 
  
  
  
Disappointed  
  
  
  
Doubtful 
 
 
 
 
Happy 
 
  
  
  
Discouraged  
  
  
  
Anxious 
 
  
  
  
Hesitant 
 
 
 
 
Isolated 
 
  
  
  
Content 
 
  
  
  
Tense 
 
  
  
  
Rejected 
 
  
  
  
Fulfilled 
 
  
  
  
Uncertain 
 
 
 
 
Left out 
 
  
  
  
Lonely 
 
  
  
  
Unsure 
 
 
 
 
Encouraged 
 
  
  
  
Angry 
 
  
  
  
Worried 
 
  
  
  
Sleeping 
problems 
 
  
  
  
Weight gain  
  
  
  
Joint aches  
  
  
  
Low energy 
 
  
  
  
Hot flushes  
  
  
  
Stress/ 
anxiety 
 
  
  
  
Night sweats  
  
  
  

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Low mood 
 
  
  
  
Brain fog 
 
  
  
  
Loss of sex 
drive 
 
  
  
  
Headaches 
 
  
  
  
Period 
changes 
 
  
  
  
Skin changes  
  
  
  
Vaginal 
dryness 
 
  
  
  
Urinary 
changes 
 
  
  
  
Painful sex  
  
  
  
Bloating 
 
  
  
  
Poor 
concentration 
 
  
  
  
Itchy skin 
 
  
  
  
Digestive 
issues 
 
  
  
  
Memory loss  
  
  
  
Irregular 
heartbeat 
 
  
  
  
Breast pain  
  
  
  
Brittle nails  
  
  
  
Hair loss 
 
  
  
  
Electric 
shock 
sensations 
 
  
  
  
Muscle 
tension 
 
  
  
  
Body odour 
 
  
  
  
Allergies 
 
  
  
  
Burning 
tongue 
 
  
  
  
Other 
 
  
  
 
 
3b. If you selected "other" in the question above, please type 
what it was (type n/a if this does not apply to you): 
 

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………………… 
 
 
Page 2/2: DRK debrief sheet (see Appendix 29) 
 
 
To preview the DRK as it will be presented via JISC Online 
Surveys, please visit this link: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-preview  
 
 
Appendix 5: Templates of the text message reminders and daily DRK email reminders 
 
Appendix 5: Templates of the daily DRK email reminders and 
text message reminders  
Daily DRK email reminder template: 
Hi,  
Welcome to Day 2 of the monitoring study. 
Your username is: pilot1 
Please remember this username as it will be used to provide 
you with your £20 voucher, you can 
contact robin.andrews@southwales.ac.uk if you forget it.  
You may open the Day 2 survey in your web browser by clicking 
the link below: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-pilot-copy 
If the link above does not work, try copying this link into 
your web browser:   
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-pilot-copy 
This link is unique to you and should not be forwarded to 
others. 
To claim your £20 Amazon voucher, you must complete all 14 of 
the 5-minute surveys within 24 hours of receiving the links 
via email, and you must complete the final follow-up survey 
within 24 hours of receiving the link via email.  
Please do not reply to this email.  If you would like to 
withdraw your data, please 
email robin.andrews@southwales.ac.uk. You can also 
email robin.andrews@southwales.ac.uk if you would like to opt 
out of receiving text message reminders.  
If you have any questions or concerns about this study, please 
email: xxxxxxxx  
We thank you again for your participation, 
The Research Team 
 

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Daily text message reminder template: 
Today’s survey has been sent to the email address you have 
provided. You can complete this survey now via this link: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-pilot-copy. Please make sure you complete and return this 
survey by 10am tomorrow morning to be eligible for the 
voucher. We thank you for your participation in this research. 
To opt out of text message reminders please email: 
robin.andrews@southwales.ac.uk 
 
     
 
Appendix 6: Participant information email templates 
 
Appendix 6: Participant information email templates 
Email template advising intervention group participants of 
their group allocation, and instructing them to complete the 
DRK survey each day for 14 days: 
Hi, 
Thank you for participating in our study. 
You have been allocated into the intervention group. 
Your username is: pilot1 
Please remember this username as it will be used to provide 
you with your £20 Amazon voucher, you can contact 
robin.andrews@southwales.ac.uk if you forget it. 
Starting from today, you will be asked to complete a 5-minute 
survey each day for the next 14 days. You must complete and 
return each survey within 24 hours of receiving the link via 
email. There will be a different link each day You may open 
the Day 1 survey in your web browser now by clicking the link 
below: 
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-preview 
If the link above does not work, try copying this link into 
your web browser:  
https://southwales.onlinesurveys.ac.uk/daily-record-keeping-
form-preview 
This link is unique to you and should not be forwarded to 
others 
Please do not reply to this email.  If you would like to 
withdraw your data, please email 
robin.andrews@southwales.ac.uk. You can also email 
robin.andrews@southwales.ac.uk if you would like to opt out of 
receiving text message reminders. 
If you have any questions or concerns about this study, please 
email: XXXXXXXX 
We thank you again for your participation, 

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The Research Team 
 
The email template advising control participants of their 
group allocation, and instructing them to carry on as usual 
for 14 days: 
Thank you for participating in our study.  
You have been allocated into the control group.  
Your username is: pilot1 
Please remember this username as it will be used to provide 
you with your £20 Amazon voucher, you can 
contact robin.andrews@southwales.ac.uk if you forget it.  
For the next 14 days, please continue with your life as usual. 
Once the 14-day period has passed you will receive a link to a 
follow-up survey via email.  
Once you have completed the follow-up survey you will be 
provided with your £20 Amazon gift voucher via email, provided 
you have completed it within the allocated time frame and have 
met the terms and conditions (see the information sheet 
attached for further guidance). 
To be eligible for the £20 Amazon voucher, you must complete the 
follow-up survey within 24 hours of receiving the link via 
email.  
Please do not reply to this email.  If you would like to 
withdraw your data, please 
email robin.andrews@southwales.ac.uk. You can also 
email robin.andrews@southwales.ac.uk if you would like to opt 
out of receiving text message reminders. If you have any 
questions or concerns about this study, please email: XXXXXXXX  
 We thank you again for your participation, 
The Research Team  
 
 
The follow-up email template sent to participants after 14 
days of either usual care or completing daily DRK surveys: 
Hi,  
  
You have now reached the end of the study; all you need to do now is complete the final 
follow-up survey (see the link below). 
  
Your username is: pilot1 
  
Please remember this username as it will be used to provide you with your £20 voucher, you 
can contact robin.andrews@southwales.ac.uk if you forget it.  
  
You may open the follow-up survey in your web browser by clicking the link below: 

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https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-
preview  
 
If the link above does not work, try copying this link into your web 
browser:  https://southwales.onlinesurveys.ac.uk/follow-up-questionnaire-preview 
  
This link is unique to you and should not be forwarded to others. 
  
Once you have completed the follow-up survey you will be sent your £20 Amazon gift 
voucher via email, provided you have completed all surveys within the allocated time 
frames and have met the terms and conditions (see the information sheet attached for 
more information).  
  
To be eligible for your £20 Amazon voucher, you must complete the follow-up survey 
within 24 hours of receiving it.  
 
Please do not reply to this email.  If you would like to withdraw your data, please 
email robin.andrews@southwales.ac.uk. You can also 
email robin.andrews@southwales.ac.uk if you would like to opt out of receiving text 
message reminders.  
  
If you have any questions or concerns about this study, please email: XXXXXXXXX  
  
We thank you again for your participation, 
  
The Research Team 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 7: The recruitment poster as presented on www.callforpartcipants.com 
 
Poster preview link: 
https://www.callforparticipants.com/study/get-feedback/OXR4U 
 
Page 1: 
 
 
 
 
 

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Page 2: 
     
 
 
 
Appendix 8: Information sheet 
 
 

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Information sheet 
Study Title: A randomised controlled trial of the effects of 
monitoring physical and emotional symptoms among 
menopausal women.  
 
You have been invited to take part in a research study about 
how a daily monitoring intervention could help women 
experiencing menopause-related symptoms. As part of this 
study, you may be asked to complete a brief, 5-minute survey 
about physical and emotional symptoms of the menopause 
each day for 14 days, which will be emailed to you at 10am 
every day. 
Before deciding whether you wish to take part in this study, 
please read the following information about the research and 
what we would like you to do. If any of the information is not 
clear please feel free to contact the lead researcher Ms. Robin 
Andrews, or her supervisor Dr Deborah Lancastle, using the 
contact details provided. Please take your time to decide 
whether or not you would like to take part.  
 
What is the purpose of the study? 
This research is being carried out as part of a PhD thesis, with 
the goal of evaluating whether a daily monitoring intervention 
could influence menopause-related health outcomes.  
This study is being carried out by Robin Andrews, who is a 
KESS-2 funded PhD student at the University of South Wales. 
This study is supervised by Dr Deborah Lancastle and Professor 
Bev John, who are both registered Health and Care Professions 
Council psychologists. Dr Lancastle has expertise in the 
psychological aspects of women’s reproductive health, and 
Professor John is experienced in developing and evaluating 
complex health interventions.  
As part of her PhD research, Robin Andrews is working with 
Health & Her, a UK-based company which provides advice and 
support for women with menopausal symptoms. The 
anonymised results of this study might be used by Health & 
Her to develop their provision for menopausal women. 

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Why have I been invited? 
You have been invited to take part in this study because you 
are an adult female who is experiencing menopause symptoms, 
and are currently experiencing at least 2 menopausal hot 
flushes per day.  
This study will involve comparing the health of two participant 
groups; therefore, we need all participants to be in good health 
and free from chronic physical or psychological conditions. 
Please do not take part if you have chronic or severe medical 
conditions including chronic fatigue syndrome, fibromyalgia, 
cancer, heart disease, thyroid disease, depression and other 
mental illnesses, or if you are not experiencing at least 2 
menopausal hot flushes per day, or are under the age of 18.  
 
 
Do I have to take part? 
It is up to you to decide whether to take part. If you do, you 
will be asked to complete an online consent form to show that 
you understand what we would like you to do. Completing this 
survey confirms that you have consented to take part and are 
happy for us to use your data.  
 
What will happen to me if I take part? 
This research involves an online study which will investigate 
whether a daily monitoring intervention could improve health 
outcomes for menopausal women. You will be randomly 
assigned to one of two groups. Group 1 will be complete the 
daily monitoring intervention (the intervention group) for 14 
days as well as a survey at the beginning and end of this 
period. Group 2 will complete the survey at the beginning and 
end of 14 days.  
After you have read this information and have completed the 
consent form on the next page, we would like you to complete 
an online survey, this will take approximately 10-minutes. You 
will be asked multiple-choice questions about your health; your 
information will be kept confidential and you cannot be 

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identified from any publication of the results. If you are 
uncomfortable with the idea of sharing such information you do 
not have to take part. 
When you have completed the online survey, you will receive 
an email from the research team. This email will explain to you 
which group you have been allocated into. You will be allocated 
at random into the intervention group, or the control group, as 
described above.  
The intervention group: 
If you are allocated into the intervention group, you will be 
asked to complete a brief, 5-minute survey each day for 14 
days, which will be sent to you via email. After the 14 days 
have passed you will be asked to complete another 10-minute 
survey, sent to you via email. Once you have returned this 
survey you will be compensated with a £20 Amazon gift 
voucher if you have met all the terms and conditions (i.e. 
you have completed all surveys and returned them within 24 
hours). If you choose, you may also be sent text message 
reminders to help you remember to complete the surveys. This 
is up to you and you can opt out of receiving reminders at any 
time. 
The control group: 
If you are allocated into the control group, you will simply 
complete the 10-minute surveys at the beginning and end of 
14 days.  Once you have completed this survey you will be 
compensated with a £20 Amazon gift voucher if you have 
met all the terms and conditions (i.e. you completed both 
surveys and returned them within 24 hours).  
 
Expenses and payments 
Respondents who fully complete this study will be eligible for a 
£20 Amazon voucher, which they will receive when they 
return the final survey. 
 
Terms and Conditions: 
To be eligible for the voucher you must satisfy the following 
criteria:   

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• You must not withdraw or drop-out from this study  
• Regardless of the group you are in, you must complete 
and submit all surveys in the links that are sent to you 
within 24 hours of receiving them.  
• You will be provided with a unique username to identify 
your responses. You must accurately confirm your 
username on each survey you complete so we can link 
your survey responses together.   
 
What will I have to do? 
If you decide to take part, please:  
1. Complete the consent form on the following page and 
proceed to the survey.  
2. Complete all questions on the survey, this will take you 
approximately 10 minutes.  
3. You will receive an email from the research team within 24 
hours, this will tell you your group allocation and provide 
instructions for the next steps of the study.    
4. If you are allocated into the intervention group: 
You will be asked to complete a brief, 5-minute survey about 
physical and emotional symptoms of the menopause each day 
for 14 days, which will be emailed to you at 10am every day. 
After 14 days have passed day you will be asked to complete a 
10-minute follow-up survey. Once you have completed this 
survey, you will be sent your £20 Amazon gift voucher. 
5. If you are allocated into the control group: 
You will not be asked to complete any daily surveys. You will 
be asked to complete a 10-minute follow-up survey around 2 
weeks from the day you received the email advising you of 
your group allocation. You will have 24 hours to complete this 
survey. Once you have completed this survey, you will be sent 
your £20 Amazon gift voucher. 
 
It can help to complete surveys in a calm environment without 
time pressure or distraction. We are interested in your own 
opinions, so we would be grateful if you could complete this 

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survey without assistance from others.  
What are the possible risks and disadvantages of taking 
part? 
The menopause is a sensitive subject, and you might feel 
uncomfortable thinking about your health and symptoms.  
Please be reassured that you cannot be identified in the thesis 
or any presentations or publications of the study results. 
However, if you are uncomfortable with the idea of sharing 
such information you do not have to take part. You might feel 
you have a physical or psychological problem after reflecting on 
your symptoms. Please note that we cannot diagnose physical 
or mental health problems from your survey responses. If you 
are concerned about your health after taking part, please 
contact your GP. We have also provided some contact and 
information sources below. If you are allocated into the control 
group you may be disappointed in not being offered to take 
part in the symptom monitoring intervention. While we are not 
currently able to offer the intervention to control participants 
once the study period has finished we will supply a list of 
symptom monitoring resources, should you be interested in 
monitoring your symptoms after taking part in this study.  
 
What are the possible benefits of taking part? 
We cannot promise that the outcome of this research will help 
you, but we hope that the information will contribute to the 
development of ways of helping women experiencing 
menopausal symptoms to help themselves. This research could 
also improve the online support available for menopausal 
women.  
 
What if there is a problem? 
If you have questions about the study itself, please contact 
Robin Andrews. If there are any other issues, please contact Dr 
Deborah Lancastle. If you are unhappy with anything about this 
study and wish to make a formal complaint, you can contact 
Jonathan Sinfield. The contact details are below.  
All responses to this survey will be kept confidential and 

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secure. All personal data (sensitive and standard) will be 
collected, retained and stored in accordance with the 
Data Protection Act (2018) and the General Data 
Protection Regulations (GDPR, 2018).  
All data provided will be kept on password protected computers 
which only the research team can access. Dr Deborah Lancastle 
will be the custodian of the data. The data will not be passed 
on to anyone outside of the research team and will be kept for 
5 years and then destroyed. Analysis of anonymised data will 
be carried out by members of the research team. Should the 
data be required for future studies, other than that described 
here, approval will be sought from the appropriate ethics panel 
at the University of South Wales.  
 
Involvement of the General Practitioner (GP) 
We will not be collecting information about your GP or 
contacting your GP. Therefore, if you are at all concerned about 
your physical or psychological wellbeing it is up to you to 
contact your GP.  
 
What will happen if I don’t carry on with the study? 
If you change your mind about taking part while you are still 
completing the survey, close down the survey by clicking the x 
in the corner of the screen and all information provided by you 
will be removed and destroyed.  To withdraw after submitting 
the survey, email Robin Andrews. You do not have to give a 
reason for withdrawing your data, and all your responses to 
every survey you have completed will be deleted. Please bear 
in mind, if you do withdraw your data it will no longer be 
possible for us to provide you with a £20 Amazon voucher and 
that once you have received your voucher it is no longer 
possible to withdraw. If you don’t notify Robin Andrews that 
you wish to withdraw, all your data will be retained in the 
study, so it is important to let Robin know if you have chosen 
to withdraw. 
 

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What will happen to the results? 
The results will form part of a doctoral thesis by Robin, and will 
be presented at academic conferences, and will be written up in 
research publications by Robin, Dr Lancastle and Professor 
John. You cannot be identified in any presentation of the 
results of this study. If you wish to find out about the outcome 
of the study you may contact the researchers (see contact 
details below). 
 
Who is organising or sponsoring the research?  
This research is sponsored by the University of South Wales, 
and is funded by USW, KESS-2, and Health & Her. KESS-2 is a 
collaboration between the Welsh Government and the 
European Social Fund.  
 
Contact details 
 
Robin Andrews: 
Email: robin.andrews@southwales.ac.uk  
Address: Ferndale building, Room 317  
University of South Wales 
Treforest 
Pontypridd 
CF37 1DL 
 
If you are unhappy about any aspect of the study, please 
contact the University of South Wales Research 
Governance Officer, Jonathan Sinfield: 
Email: jonathan.sinfield@southwales.ac.uk  
Address: 8 Forest Grove building, Room 10 
University of South Wales 
Treforest  
Pontypridd  
CF37 1DL 
 
Thank you for taking the time to read this information 
sheet. You may find the following sites helpful for 

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information about the menopause and mental health 
problems: 
NHS website: https://www.nhs.uk/conditions/menopause/  
British Menopause Society: https://thebms.org.uk/  
Samaritans: https://www.samaritans.org/ 
 
 
Appendix 9: Consent form  
 
Title of Project: A randomised controlled trial of the effects of 
monitoring physical and emotional symptoms among 
menopausal women 
Name of Researcher: Robin Andrews 
Name of supervisor: Dr Deborah Lancastle 
 
1. I confirm that I have read and understand the information 
sheet for the above study. I have had the opportunity to 
consider the information, ask questions, and have had these 
answered satisfactorily. 
 
2. I understand that my participation is voluntary and that I 
am free to withdraw my data up I receive my £20 Amazon 
voucher, without any consequence to myself.   
 
3. I agree to my survey responses being recorded and I 
understand how this data will be stored, destroyed, 
anonymised, who will have access to it, and how long it will be 
kept. 
 
4. I consent to the processing of my personal 
information for the purposes of this research study. I 
understand that such information will be treated as 
confidential and will be handled in accordance with the 
Data Protection Act and the General Data Protection 
Regulations (GDPR) 2018 and will be destroyed after 5 
years. 
 

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5. I agree to my anonymised data being used in a PhD thesis 
and in conference presentations and articles for academic 
journals. 
 
6. I understand that by submitting all completed surveys 
implies that I consent to participate in this research. 
 
7. I understand that after I complete the first survey I will 
sent an email which will tell me whether I have been allocated 
into the intervention group, or  control group. 
 
8. I understand that to claim my £20 Amazon voucher I must 
complete and return each survey within 24 hours of receiving 
them.   
 
9. I agree to take part in the above study. 
 
 
 
 
  
Appendix 10: Original copies of validated questionnaires 
 
Appendix 10: Original copies of validated questionnaires 
Monitor/Blunter Style Scale  
1. Vividly imagine that you are afraid of the dentist and have to get some dental work done. 
Which of the  
following would you do? Check all of the statements that might apply to you.  
___ I would ask the dentist exactly what work was going to be done.  
___ I would take a tranquilizer or have a drink before going.  
___ I would try to think about pleasant memories.  
___ I would want the dentist to tell me when I would feel pain.  
___ I would try to sleep.  
___ I would watch all the dentist's movements and listen for the sound of the drill.  

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___ I would watch the flow of water from my mouth to see if it contained blood.  
___ I would do mental puzzles in my mind.  
2. Vividly imagine that you are being held hostage by a group of armed terrorists in a public 
building.  
Which of the following would you do? Check all of the statements that might apply to you.  
___ I would sit by myself and have as many daydreams and fantasies as I could.  
___ I would stay alert and try to keep myself from falling asleep.  
___ I would exchange life stories with the other hostages.  
___ If there was a radio present, I would stay near it and listen to the bulletins about what the  
police were doing.  
___ I would watch every movement of my captors and keep an eye on their weapons.  
___ I would try to sleep as much as possible.  
___ I would think about how nice it's going to be when I get home.  
___ I would make sure I knew where every possible exit was. 
3. Vividly imagine that, due to a large drop in sales, it is rumored that several people in your  
department at work will be laid off. Your supervisor has turned in an evaluation of your work for  
the past year. The decision about lay-offs has been made and will be announced in several days.  
Check all of the statements that might apply to you. 
___ I would talk to my fellow workers to see if they knew anything about what the  
supervisor evaluation of me said.  
___ I would review the list of duties for my present job and try to figure out if I had fulfilled them  
all.  
___ I would go to the movies to take my mind off things.  
___ I would try to remember any arguments or disagreements I might have had that would  

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have resulted in the supervisor having a lower opinion of me.  
___ I would push all thoughts of being laid off out of my mind.  
___ I would tell my spouse that I'd rather not discuss my chances of being laid off.  
___ I would try to think which employees in my department the supervisor might have  
thought had done the worst job.  
___ I would continue doing my work as if nothing special was happening.  
 
4. Vividly imagine that you are on an airplane, thirty minutes from your destination, when the  
plane unexpectedly goes into a deep dive and then suddenly levels off. After a short time, the  
pilot announces that nothing is wrong, although the rest of the ride may be rough. You,  
however, are not convinced that all is well. Check all of the statements that might apply to you.  
___ I would carefully read the information provided about safety features in the plane and  
make sure I knew where the emergency exits were.  
___ I would make small talk with the passenger beside me.  
___ I would watch the end of the movie, even if I had seen it before.  
___ I would call for the flight attendant and ask what exactly the problem was.  
___ I would order a drink from the flight attendant or take a tranquilizer.  
___ I would listen carefully to the engines for unusual noises and would watch the crew to  
see if their behavior was out of the ordinary.  
___ I would talk to the passenger beside me about what might be wrong.  
___ I would settle down and read a book or magazine or write a 
letter. 
 
The 10-item neuroticism scale extracted from the 
International Personality Item Pool scales (NEO-IPIP-
10) 
 

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The Items in Each of the Preliminary IPIP Scales Measuring 
Constructs Similar to Those in Costa and McCrae's (1992) five 
NEO-PI-R domains 
 
Neuroticism 10-item scale (Alpha = .86) 
 
+ keyed:  
 
Often feel blue.  
 
Dislike myself. 
 
Am often down in the dumps. 
 
Have frequent mood swings. 
 
Panic easily.  
 
– keyed:  
 
Rarely get irritated. 
 
Seldom feel blue.  
 
Feel comfortable with myself.  
 
Am not easily bothered by things.  
 
Am very pleased with myself 
 
Link to scale website and scale information: 
https://ipip.ori.org/newNEOKey.htm#Neuroticism  
 
The original General Help Seeking Questionnaire 
(GHSQ) 
Note: Help sources should be modified to match the target 
population. 

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The Health anxiety subscale extracted from The Health 
Orientation Scale (HOS) 
INSTRUCTIONS:  
The items listed below refer to people's health. Please read 
each item carefully and decide to what extent it is 
characteristic of you. Give each item a rating of how much it 
applies to you by using the following scale: A = Not at all 
characteristic of me. B = Slightly characteristic of me. C = 
Somewhat characteristic of me. D = Moderately characteristic 
of me. E = Very characteristic of me. 
Health Anxiety: 
The items on the Health Anxiety (HA) subscale refer to anxious 
feelings associated with the status of one's health. More 
specifically, these items were designed to tap people's 
feelings of tension, discomfort and anxiety about their 
physical health. People who endorse these items are those who 
experience chronic anxiety as a result of thinking about their 
physical health. 
I feel anxious when I think about my health. 
ABCDE 
I'm worried about how healthy my body is. 

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ABCDE 
Thinking about my health leaves me with an uneasy feeling. 
ABCDE 
I usually worry about whether I am in good health.  
ABCDE 
I feel nervous when I think about the status of my physical 
health. 
ABCDE 
Link to full HOS as presented online: 
https://www.midss.org/sites/default/files/hos.pdf  
 
The Health Consciousness subscale extracted from The 
Health Orientation Scale (HOS)  
INSTRUCTIONS: 
The items listed below refer to people's health. Please read 
each item carefully and decide to what extent it is 
characteristic of you. Give each item a rating of how much it 
applies to you by using the following scale: A = Not at all 
characteristic of me. B = Slightly characteristic of me. C = 
Somewhat characteristic of me. D = Moderately characteristic 
of me. E = Very characteristic of me. 
Health Consciousness: 
The items on the Personal Health Consciousness (PHC) subscale 
refer to an awareness of one's health. These items were 
designed to measure people's tendency to think about and to 
reflect about their health. People who endorse these items are 
those who think about that status of their physical health, 
and who in general are reflective about the nature of the 
health and wellness of their body. 
I am very aware of how healthy my body feels.  
ABCDE 
I notice immediately when my body doesn't feel healthy. 
ABCDE 
I'm sensitive to internal bodily cues about my health. 
ABCDE 
I know immediately when I'm not feeling in great health. 
ABCDE 
I'm very aware of changes in my physical health. 
ABCDE 
Link to full HOS as presented online: 
https://www.midss.org/sites/default/files/hos.pdf  
 
The original Willingness to Communicate about Health (WTCH) Measure 
 
Please use the following scale to answer the items 
listed below:  

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1 = Strongly Disagree 
2 = Mildly Disagree 
3 = Undecided 
4 = Mildly Agree 
5 = Strongly Agree 
 
_____   1. In general, I feel comfortable talking 
with physicians about my health. 
 
_____   2. I usually feel relaxed when talking about 
my health problems with my family. 
 
_____   3. I typically feel comfortable giving others 
information about my health status. 
 
_____   4. In general, I don’t mind discussing my 
health status with friends. 
 
_____   5. I typically discuss emotional concerns I 
have about my health status with health 
providers. 
 
_____   6. I usually feel awkward talking about my 
health problems with others. 
 
_____   7. I would not have a problem talking to 
nurses about my health status. 
 
_____   8. In general, I would not mind discussing my 
health with other patients who have a similar 
health history. 
 
_____   9. I am generally willing to engage in a 
conversation about information related to my 
health status if someone asks me a question 
about my condition. 
 
_____ 10. I would not be willing to discuss my fears 
about my health condition with others. 

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Scoring: Add the scores together, reversing the 
scores for items 6 and 10. The higher the score, the 
more willing persons are to communicate about their 
health 
 
Decision self-efficacy scale 
My confidence in making an informed choice 
Below are listed some things involved in making an 
informed choice. Please show how confident you feel 
in doing these things by circling the number from 0 
(not at all confident) to 4 (very confident) for each 
item listed below.  
I feel confident that I can:  
1. Get the facts about the medication choices 
available to me  
not at all confident 0 1 2 3 4 very confident  
2. Get the facts about the benefits of each choice  
not at all confident 0 1 2 3 4 very confident  
3. Get the facts about the risks and side effects of 
each choice  
not at all confident 0 1 2 3 4 very confident  
4. Understand the information enough to be able to 
make a choice  
not at all confident 0 1 2 3 4 very confident  
5. Ask questions without feeling dumb  
not at all confident 0 1 2 3 4 very confident  
6. Express my concerns about each choice  
not at all confident 0 1 2 3 4 very confident  
7. Ask for advice  
not at all confident 0 1 2 3 4 very confident  
8. Figure out the choice that best suits me  
not at all confident 0 1 2 3 4 very confident  
9. Handle unwanted pressure from others in making my 
choice  
not at all confident 0 1 2 3 4 very confident  
10. Let the clinic team know what’s best for me  
not at all confident 0 1 2 3 4 very confident  
11. Delay my decision if I feel I need more time  
not at all confident 0 1 2 3 4 very confident  
 

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The General self-efficacy scale: 
1 
I can always manage to solve difficult problems if I try 
hard enough.  
2 
If someone opposes me, I can find the means and ways to 
get what I want.  
3 
It is easy for me to stick to my aims and accomplish my 
goals.  
4 
I am confident that I could deal efficiently with 
unexpected events.  
5 
Thanks to my resourcefulness, I know how to handle 
unforeseen situations.  
6 
I can solve most problems if I invest the necessary 
effort.  
7 
I can remain calm when facing difficulties because I can 
rely on my coping abilities.  
8 
When I am confronted with a problem, I can usually find 
several solutions.  
9 
If I am in trouble, I can usually think of a solution.  
10 
I can usually handle whatever comes my way. 
Scoring key: 1 = Not at all true   2 = Hardly true   3 = 
Moderately true   4 = Exactly true 
 
 
The Daily Record Keeping form 
APPENDIX H 
Daily Record Keeping form used in 
Study 2 
 
Daily Monitoring Form  
 
Personal code number…………………………. 
 
Date………………………………… 
Part 1 
Day of study 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
Part 2: Emotions 
Nervous 
 
 
 
 
 
 
 
Positive 
 
 
 
 
 
 
 
Relieved 
 
 
 
 
 
 
 
Sad 
 
 
 
 
 
 
 
Hopeful 
 
 
 
 
 
 
 
Confident 
 
 
 
 
 
 
 
Disappointed 
 
 
 
 
 
 
 
Rating scale  
Happy 
 
 
 
 
 
 
 
 
 
 
Part 3 
Discouraged 
 
 
 
 
 
 
 
Anxious 
 
 
 
 
 
 
 
Unsure 
 
 
 
 
 
 
 
Content 
 
 
 
 
 
 
 
Tense 
 
 
 
 
 
 
 
Hesitant 
 
 
 
 
 
 
 
Fulfilled 
 
 
 
 
 
 
 
Doubtful 
 
 
 
 
 
 
 
Uncertain 
 
 
 
 
 
 
 
Encouraged 
 
 
 
 
 
 
 
Angry 
 
 
 
 
 
 
 
1 
2 
3 
Not at all: leave the box blank if you 
have not experienced that symptom 
Mild: if you have experienced the 
symptom but it doesn’t interfere with 
Moderate: if you have experienced the 
symptom and it interferes to some 
Severe: if the symptom has a markedly 
negative effect on how well you 

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Worried 
 
 
 
 
 
 
 
Optimistic: pregnancy  
 
 
 
 
 
 
Pessimistic: 
pregnancy 
 
 
 
 
 
 
 
Part 3: Physical symptoms 
Breast tenderness 
 
 
 
 
 
 
 
Chest pain/tightness 
 
 
 
 
 
 
 
Menstrual cramps 
 
 
 
 
 
 
 
Shortness of breath 
 
 
 
 
 
 
 
Muscle tension 
 
 
 
 
 
 
 
Sweatiness 
 
 
 
 
 
 
 
Nausea 
 
 
 
 
 
 
 
Abdominal bloating 
 
 
 
 
 
 
 
Fatigue/tiredness 
 
 
 
 
 
 
 
Cold hands/feet 
 
 
 
 
 
 
 
Racing heart 
 
 
 
 
 
 
 
Spotting / bleeding 
 
 
 
 
 
 
 
Part 4: Ways of coping with the waiting period 
I turned my attention away from treatment by thinking about other things or doing 
some activity 
 
 
 
 
 
 
 
I made a plan of action and followed it 
 
 
 
 
 
 
 
I accepted there was nothing I could do 
 
 
 
 
 
 
 
I did something with the implicit intention of relaxing 
 
 
 
 
 
 
 
I wished the situation would go away or somehow be over with 
 
 
 
 
 
 
 
I expressed my emotions 
 
 
 
 
 
 
 
I tried to make the most of the situation 
 
 
 
 
 
 
 
Part 5: Ways of thinking about the waiting period 
I perceive that the waiting period is stressful 
 
 
 
 
 
 
 
I can control what happens in the waiting period 
 
 
 
 
 
 
 
The waiting period could have a negative impact on me 
 
 
 
 
 
 
 
I have what it takes to cope with the waiting period 
 
 
 
 
 
 
 
The waiting period could have a positive impact on me 
 
 
 
 
 
 
 
Part 6: About the intervention card  
1. How many times did you read the card today? (write the total number of times each day)  
 
 
 
 
 
 
 
2. How did you feel after reading the card? (1 = felt more negative, 2 = felt the same, 3 = felt more 
positive)  
 
 
 
 
 
 
 
     
 
 
 
Appendix 12: The 3 debrief sheets: 
 
Debriefing Form 1- Baseline Survey 
 
Study Title: A randomised controlled trial of the effects of 
monitoring physical and emotional symptoms among 
menopausal women. 
1 
2 
3 
Not at all: leave the box blank if you 
have not experienced that symptom that 
Mild: if you have experienced the 
symptom but it doesn’t interfere with 
Moderate: if you have experienced the 
symptom and it interferes to some 
Severe: if the symptom has a markedly 
negative effect on how well you 

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Thank you for participating in this survey! 
 
The next steps: 
 
Keep an eye on your inbox, as you will shortly receive an email 
from the research team. This email will be sent from this 
address: theresearchteam@southwales.ac.uk. If you do not 
receive an email within the next 24 hours, please check your 
junk/spam folder. This email will explain to you which group 
you have been allocated into. You will either be allocated into 
the intervention group or the control group.  Full 
information on what you need to do next will be provided. Once 
you have completed this study you will be sent your £20 
Amazon gift voucher.  
 
Voucher eligibility details: 
 
You will be sent your £20 Amazon voucher after you return the 
final 10-minute survey, which will be emailed to you in 
approximately 2 weeks' time. Only one £20 voucher will be 
provided per participant. Amazon vouchers will be sent to those 
who have fully completed and submitted the research materials 
sent to them via email, did not withdraw or drop-out from the 
study, and had accurately confirmed their username on each 
survey they submitted. 
 
To be eligible for the voucher you must satisfy the following 
criteria:  
• You must not withdraw or drop-out from this study. 
• You must complete and submit all surveys in the links 
which are sent to you within 24 hours. 
• You must accurately confirm your username on each 
survey you complete. Your username will remain the 
same throughout the duration of this study and will be 
provided on all emails sent to you from the research 
team.   

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We would appreciate it if you do not discuss your responses to 
the survey with others, to ensure that responses aren’t 
influenced by other people’s opinions. 
 
What if I decide to withdraw? 
 
You can withdraw your data any time before you receive your 
£20 Amazon voucher. To withdraw, email Robin Andrews 
(see contact details below). Withdrawal of your data will mean 
that your survey responses will be permanently deleted and 
destroyed. Please note that if you withdraw you will not be 
eligible for a voucher.  
 
Please note that if you drop-out from this study by no longer 
completing surveys and ceasing contact with the research 
team, all data you have provided up until that point will be 
retained unless you contact Robin Andrews via email with your 
decision to withdraw your data from this study.  
 
We thank you again for your contribution to this research!  
 
What if I have questions or concerns about this 
research?  
 
If you have any questions or concerns about this survey, 
please contact the lead researcher: Robin Andrews,  
 
Email: robin.andrews@southwales.ac.uk    
 
Address: Ferndale building, room 317   
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL  
 
If you are worried about this research or concerned about how 

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it is being conducted, please contact Robin’s supervisor: Dr 
Deborah Lancastle,  
 
  
Complaints procedure:  
 
If you wish to make a formal complaint, contact the Research 
Governance Officer of the University of South Wales: Mr 
Jonathon Sinfield, 
 
Email: jonathan.sinfield@southwales.ac.uk     
 
Address: 8 Forest Grove, room 10  
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL  
 
   
Support and information services:  
 
If you are concerned about your physical or psychological well-
being, you should contact your GP or a healthcare professional. 
If you feel you require further support or information for 
menopause-related or mental health issues, please visit the 
following websites:  
 
NHS website: https://www.nhs.uk/conditions/menopause/    
 
British Menopause Society: https://thebms.org.uk/    
 
Samaritans: https://www.samaritans.org/     
 
 
 
Debriefing Form 2- Daily Record Keeping Form 
 

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Study Title: A randomised controlled trial of the effects of 
monitoring physical and emotional symptoms among 
menopausal women. 
The next steps: 
 
Keep an eye on your inbox, as you will shortly receive an email 
from the research team with a link to the next survey for you 
to complete within 24 hours. This email will be sent from this 
address: theresearchteam@southwales.ac.uk. If you do not 
receive this email within the next 24 hours please check your 
junk/spam folder, or email robin.andrews@southwales.ac.uk.   
 
If you have opted in, you will also be sent text message 
reminders to help you remember to complete the 
questionnaires. You can opt out of receiving reminders at any 
time. To opt out of receiving text reminders, just email 
robin.andrews@southwales.ac.uk requesting to stop text 
reminders.  
 
What if I decide to withdraw? 
 
You can withdraw your data any time before you receive your 
£20 Amazon voucher. To withdraw, email Robin Andrews 
(see contact details below). Withdrawal of your data will mean 
that your survey responses will be permanently deleted and 
destroyed. Please note that if you withdraw you will not be 
eligible for a voucher.   
 
If you decided to withdraw midway through completing a 
survey by clicking the X in the corner of the screen or closing 
your browser, all data you have provided on that specific 
survey up until that point will be destroyed. However, any data 
you have submitted by completing previous surveys will be 
retained. Please note that if you drop-out from this study by no 

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longer completing surveys and ceasing contact with the 
research team, all data you have provided up until that point 
will be retained unless you contact Robin Andrews via email 
with your decision to withdraw your data from this study. 
 
Thank you again for your contribution to this research!  
 
What if I have questions or concerns about this 
research?  
 
If you have any questions or concerns about this survey, 
please contact the lead researcher: Robin Andrews,  
 
Email: robin.andrews@southwales.ac.uk    
 
Address: Ferndale building, room 317   
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL  
 
If you are worried about this research or concerned about how 
it is being conducted, please contact Robin’s supervisor: Dr 
Deborah Lancastle,  
 
Complaints procedure:  
If you wish to make a formal complaint, contact the Research 
Governance Officer of the University of South Wales: Mr 
Jonathon Sinfield, 
 
Email: jonathan.sinfield@southwales.ac.uk     
 
Address: 8 Forest Grove, room 10  
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL 

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Support and information services:  
If you are concerned about your physical or psychological well-
being, you should contact your GP or a healthcare professional. 
If you feel you require further support or information for 
menopause-related or mental health issues, please visit the 
following websites:  
 
NHS website: https://www.nhs.uk/conditions/menopause/    
 
British Menopause Society: https://thebms.org.uk/    
 
Samaritans: https://www.samaritans.org/     
 
 
 
Debriefing Form 3- Follow-up Questionnaire 
 
Study Title: A randomised controlled trial of the effects of 
monitoring physical and emotional symptoms among 
menopausal women. 
Thank you for participating in this survey! 
 
The aim of this study was to explore whether daily monitoring 
of symptoms and emotions could lead to improvements in 
health or changes in behaviour. The findings from this research 
will help medical professionals understand whether a simple, 
cost-effective intervention could help women with menopausal 
symptoms get the treatment that they need. 
 
Terms and conditions: 
You will be emailed your £20 Amazon gift voucher within the 
next 24 hours. Make sure you check your junk/spam folder if 
you have not received it after 24 hours, if you have still not 
received it please email robin.andrews@southwales.ac.uk. Only 
one £20 voucher will be provided per participant. Amazon 
vouchers will be sent to those who fully completed the research 

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materials sent to them via email, did not withdraw from the 
study, and had accurately confirmed their username on each 
survey they submitted.  
 
To be eligible for the voucher you must satisfy the following 
criteria:  
• You must not withdraw or drop-out from this study 
• You must complete and submit all surveys in the links 
which are sent to you within the stated time periods. You 
will have had 24 hours to complete the follow-up survey.  
• If you were allocated into the intervention group you must 
have completed the 5-minute surveys each day (within 24 
hours of the survey being received via email) for 14 days. 
• You must have accurately confirmed your username on 
each survey you completed. Your username will remain 
the same throughout the duration of this study and will be 
provided on all emails sent to you from the research 
team. 
 
What if I decide to withdraw? 
 
You can withdraw your data any time before you receive 
your £20 Amazon voucher. To withdraw, email: 
robin.andrews@southwales.ac.uk. Withdrawal of your data will 
mean that your survey responses will be permanently deleted 
and destroyed. Please note that if you withdraw you will not be 
eligible for a voucher.   
 
Please note that if you drop-out from this study by no longer 
completing surveys and ceasing contact with the research 
team, all data you have provided up until that point will be 
retained unless you contact Robin Andrews via email with your 
decision to withdraw your data from this study. 
 
Thank you again for your contribution to this research!  
 

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What if I have questions or concerns about this 
research?  
If you have any questions or concerns about this survey, 
please contact the lead researcher: Robin Andrews,  
 
Email: robin.andrews@southwales.ac.uk    
Address: Ferndale building, room 317   
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL  
 
If you are worried about this research or concerned about how 
it is being conducted, please contact Robin’s supervisor: Dr 
Deborah Lancastle,  
 
  
Complaints procedure:  
If you wish to make a formal complaint, contact the Research 
Governance Officer of the University of South Wales: Mr 
Jonathon Sinfield, 
 
Email: jonathan.sinfield@southwales.ac.uk     
Address: 8 Forest Grove, room 10  
University of South Wales  
Treforest  
Pontypridd  
CF37 1DL  
 
   
Support and information services:  
If you are concerned about your physical or psychological well-
being, you should contact your GP or a healthcare professional. 
If you feel you require further support or information for 
menopause-related or mental health issues, please visit the 
following websites:  
 

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NHS website: https://www.nhs.uk/conditions/menopause/    
 
British Menopause Society: https://thebms.org.uk/    
 
Samaritans: https://www.samaritans.org/     
 
Symptom monitoring tools:  
 
If you were allocated into the control group and did not get an 
opportunity to engage in the symptom monitoring intervention, 
please see the following online symptom monitoring tools and 
mobile apps. If you were in the intervention group but feel you 
have benefited from monitoring your symptoms and would like 
to continue you can also use the following online tools and 
mobile apps:  
 
Health & Her online symptom tool: 
https://healthandher.com/symptom-tool/  
 
Health & Her mobile app (IOS & Googleplay): 
https://apps.apple.com/gb/app/health-her-menopause-
app/id1519199698  
 
Symptom checker from WebMD: 
https://symptoms.webmd.com/default.htm  
 
Clue (a free period tracker app on IOS only): 
https://helloclue.com/  
 
Flaredown (a free web and mobile app on Android & iOS): 
http://flaredown.com/ 
 
 
Appendix 13: The researcher safety protocol  
 
Researcher safety protocol 
 
Study name: 

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A randomised controlled trial of the effects of monitoring physical and emotional symptoms 
among menopausal women.  
 
What are the hazards? 
 
This study poses no foreseeable risks of physical harm to the research team or to the 
research participants, because all research will be carried out online. Other potential risks 
are:   
 
1. Participants with physical or mental health problems might consult Robin for help, 
and financial remuneration brings the risk that participants may complain to her if 
they do not meet the conditions for remuneration. 
2. Part of the study requires participants to provide their email address in order to 
participate in this research and claim their incentive (a £20 Amazon voucher) for 
completing the study, which means that participants’ personal contact details will be 
known to Robin. Participants who indicate that they would like to be sent text 
message reminders (which will prompt them to complete the surveys) will also be 
asked to provide their mobile phone number.  
3. Survey respondents who have been allocated into the control group might be 
disappointed that they were not given an opportunity to engage in the daily 
symptom monitoring intervention.   
Who might be harmed and how? 
 
1. Robin could be approached by participants wishing to complain and pressurise her 
into providing remuneration for which they are not eligible, and she could be asked 
for advice she is not qualified to give. Such challenging communications put Robin at 
risk of worry and distress.  
 
2. Survey respondents will be asked to provide personally identifiable information 
(email addresses and mobile phone numbers) in order to claim their remuneration 
or be sent daily reminders to complete the daily monitoring survey. Therefore, this 
presents the risk of privacy breaches that might harm them if these details became 
known to others. 
 
3. Control participants might feel disappointed that they were not given an opportunity 
to engage in the daily monitoring intervention, and they may approach Robin 
wishing to complain or pressurise her into allocating them into the intervention 
group.  
 
What is being done to control the risks? 
 

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1. There is a small risk that participants may consult Robin for help for physical or 
mental health problems, or they may disclose information which may require 
notification or follow up. To mitigate these risks, Robin will use a separate email 
address from her professional one to contact recruited participants. This is the email 
address: theresearchteam@southwales.ac.uk. All emails sent from this address will 
include a note at the end stating the following “Please do not reply to this email.  If 
you have questions or concerns about this study, or you would like to withdraw, 
please email robin.andrews@southwales.ac.uk. You can also email 
robin.andrews@southwales.ac.uk if you would like to opt out of text message 
reminders.” This email address will be used to advise recruited participants (that is 
participants who have returned the completed baseline survey, including the 
consent form) with their group allocation, their unique username, and provide 
further instructions. This email address will also be used to email the daily 
monitoring intervention to intervention group participants each day of the 
intervention period, as well as the follow-up survey to all participants. This method 
will mitigate risks of an instantaneous dialogue emerging between Robin and the 
participants, therefore reducing the chances of experimenter biases occurring should 
Robin feel the need to respond to any queries. This will also reduce the risks of 
participants disclosing information to Robin which may need further action.   
 
2. The information sheet will direct participants to only to contact Robin (via her 
personal USW email address) with questions about the mechanics of completing the 
survey. If participants have any questions about anything else related to the survey 
such as Health & Her, the menopause, or concerns about the study, they will be 
directed to the Director of Studies (Dr Deborah Lancastle) in the first instance. If 
participants have concerns or complaints that cannot be answered satisfactorily by 
Deborah on consultation with the wider research team then the issue will be 
referred to Jon Sinfield.  It is also clearly stated in the information sheet that the 
research team cannot provide medical advice and that any respondents who are 
concerned should contact their GP. In terms of complaints about eligibility 
for/claiming the voucher, the steps participants need to take to ensure they are 
eligible to claim the voucher are clearly stated on the information sheet and 
repeated in the final debrief sheet, minimising the likelihood that participants could 
claim they didn’t know they had to satisfy certain criteria to be eligible for 
remuneration. Together, these controls should minimise any chance of Robin 
experiencing negative consequences from any potential issues a participant might 
have with the research, and provide a clear protocol for action should problems 
arise.  
 

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3. All email addresses and phone numbers will be stored separately from survey 
responses on password protected Excel documents, and will only be accessible to 
Robin and her supervisors. Text messages will be sent from the online text message 
management platform ClickSend (www.clicksend.com) which will be accessed by 
Robin via a USW password protected computed, therefore participant’s phone 
numbers will not be stored on Robin’s personal telecommunications devices. To 
enable participants to withdraw their data should they wish, and to ensure that 
personally identifiable information is not stored alongside responses to the 
intervention and follow-up materials, recruited participants will be provided with a 
unique username which will be repeated in all email correspondence: “Your username 
is: Participant1 please retain this information as you will be asked to confirm it on all 
surveys you complete”. Participants will be asked to confirm their unique username 
at the beginning of each research material they complete (i.e. the daily monitoring 
surveys and the follow-up survey). The data will not be passed on to anyone outside 
of the research team and will be kept for five years and then destroyed. Should the 
data be required for further studies other than described here, approval will be sought 
from the appropriate ethics panel at the University of South Wales.  
 
4. Participants who are disappointed with their group allocation will be reminded that 
their decision to engage in the study is voluntary and they are free to withdraw their 
data from the study at any point up until they receive their £20 Amazon voucher. They 
will be directed to read the information sheet which explains the importance of 
comparing the monitoring intervention group with a non-monitoring control group. 
On the third debrief sheet, which will be presented at the end of the final follow-up 
survey, all participants are given information on online tools and mobile apps which 
they can use to monitor their symptoms, should they wish.  
 
What further action is necessary? 
 
1. The strategies above are tried and tested methods of ensuring that student 
researchers are protected from the implications of inappropriate or distressing 
communication with participants. Deborah and Bev have many years of experience 
of managing applied research and student supervision and will take appropriate 
action as and when needed.  
2. Robin has completed the necessary GDPR training so is already mindful of the 
correct way to manage data confidentially. Names and contact details for 
participants will be collected in the ways described above, to ensure that 
participants’ identities are stored separately from their survey responses.  
 
How will the actions be carried out? 

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1. Robin will use a separate email address from her professional one to contact recruited 
participants: (theresearchteam@southwales.ac.uk). All emails sent from this address will 
include a note at the end stating the following “Please do not reply to this email.  If you have 
questions or concerns about this study, or you would like to withdraw, please email 
robin.andrews@southwales.ac.uk. You can also email robin.andrews@southwales.ac.uk if 
you would like to opt out of text message reminders.” This email address will be used to 
advise recruited participants (that is participants who have returned the completed baseline 
survey, including the consent form) with their group allocation, their unique username, and 
provide further instructions. This email address will also be used to email the DRK 
intervention to intervention group participants each day of the intervention period, as well 
as the follow-up survey to all participants.  
 
2. The information sheet will direct participants to only to contact Robin (via her personal 
USW email address) with questions about the mechanics of completing the survey. If 
participants have any questions about anything else related to the survey such as Health & 
Her, the menopause, or concerns about the study, they will be directed to the Director of 
Studies (Dr Deborah Lancastle) in the first instance. If participants have concerns or 
complaints that cannot be answered satisfactorily by Deborah on consultation with the 
wider research team then the issue will be referred to Jon Sinfield. The information sheet 
will include the following disclaimer, so that it is made clear to participants that medical 
advice should be sought from a GP or other help professional, and not the research team: 
 
“Please note that we are not able to diagnose any physical or mental health problem from 
your responses to this survey. If you are at all concerned about your physical or mental 
health you should contact your own General Practitioner (GP) and/or other sources of help. 
We have provided some examples of help sources below.” 
 
3. All email addresses will be stored on password protected Excel documents separately 
from survey responses, which will only be accessible to Robin and her supervisors. To enable 
participants to withdraw their data should they wish, and ensure that personally identifiable 
information is not stored alongside responses to the intervention and follow-up materials, 
recruited participants will be provided with a unique username over email (i.e. ’Your 
username is: Participant1 please retain this information as you will be asked to confirm it on 
all surveys you complete’) which they will be asked to confirm at the beginning of each 
research material they complete (i.e. the DRK surveys and the follow-up survey).   
 
4. The third and final debrief sheet (see Appendix 30- Debrief 3 follow-up survey) will 
include the following information to all participants: 
 
“Symptom monitoring tools:   

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If you were allocated into the control group and did not get an opportunity to engage in the 
symptom monitoring intervention, please see the following online symptom monitoring 
tools and mobile apps. If you were in the intervention group but feel you have benefited 
from monitoring your symptoms and would like to continue you can also use the following 
online tools and mobile apps:   
  
Health & Her online symptom tool: https://healthandher.com/symptom-tool/   
  
Health & Her mobile app (IOS & Googleplay): https://apps.apple.com/gb/app/health-her-
menopause-app/id1519199698   
  
Symptom checker from WebMD: https://symptoms.webmd.com/default.htm   
  
Clue (a free period tracker app on IOS only): https://helloclue.com/   
  
Flaredown (a free web and mobile app on Android & iOS): http://flaredown.com/”  
 
 
When will the actions be carried out? 
Once ethics approval has been granted.   
 
This risk assessment will be  retained  for  future  reference  
and  if  there  are any  significant  changes  or  new  work  
practices  then  the  assessment will be reviewed.  
 
 
 
 
 

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Appendix 14: The risk assessment table: 
 
Risk Assessment  
 
Assessment of: A randomised controlled trial 
of the effects of monitoring physical and 
emotional symptoms among menopausal women. 
 
 
Name of Assessor: Robin Andrews 
 
Assisted by: Dr Deborah Lancastle  
Assessment 
date: 14.10.2020 
Date of 
Next review: 31/11/2020 
 
Task/Activit
y 
Hazards/Person
s at Risk 
Existing Control Measures 
Risk Evaluation 
Further Control Measures / 
Recommendations 
Date 
Action 
Completed 
Likelihoo
d (L) 
Severit
y (S) 
L 
x 
S 
Part of the 
study 
requires 
participants 
to provide 
their email 
address in 
order to 
engage in 
the study 
and receive 
their 
incentive (a 
£20 Amazon 
voucher) for 
completing 
the survey. 
Participants 
who opt in 
to being 
sent daily 
text message 
reminders 
The 
participants 
could be at 
risk of data 
protection 
breaches, 
especially if 
their email 
addresses fall 
into the wrong 
hands from 
being stored 
improperly.  
Robin will use a separate email 
address from her professional one 
to contact recruited 
participants: 
(theresearchteam@southwales.ac.uk
). All emails sent from this 
address will include a note at 
the end stating the following 
“Please do not reply to this 
email.  If you have questions or 
concerns about this study, or you 
would like to withdraw, please 
email 
robin.andrews@southwales.ac.uk. 
You can also email 
robin.andrews@southwales.ac.uk if 
you would like to opt out of text 
message reminders.”  
All email addresses will be 
stored on password protected 
Excel documents separately from 
survey responses, which will only 
be accessible to Robin and her 
2 
2 
4 This research team has conducted a 
prior study which supplied 
remuneration to participants via 
email (ethics reference: 200401HR) 
to good effect with no 
repercussions.  
An alternative method to providing 
users with the voucher anonymously 
(without need for their email 
addresses) would be by directing 
them to a website which will host 
the Amazon voucher, following input 
of a key word given to them at the 
end of the survey. However, this 
technology is not available to the 
research team at present. Therefore, 
no further control measures are 
recommended due to limited 
resources.  
On receipt 
of 
approval 
for 
methodolog
y (before 
surveys 
are made 
live) 

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will be 
asked to 
provide 
their mobile 
phone 
number.  
 
supervisors.  Text messages will 
be sent from the online text 
message management platform 
ClickSend (www.clicksend.com) 
which will be accessed by Robin 
via a USW password protected 
computed, therefore participant’s 
phone numbers will not be stored 
on Robin’s personal 
telecommunications devices. To 
enable participants to withdraw 
their data should they wish, and 
ensure that personally 
identifiable information is not 
stored alongside responses to the 
intervention and follow-up 
materials, recruited participants 
will be provided with a unique 
username over email (i.e. ’Your 
username is: Participant1 please 
retain this information as you 
will be asked to confirm it on 
all surveys you complete’) which 
they will be asked to confirm at 
the beginning of each research 
material they complete (i.e. the 
DRK surveys and the follow-up 
survey).   
 
Having an 
open 
dialogue 
with Robin 
during the 
research 
period could 
put the lead 
researcher 
in a 
position 
where 
participants 
will make 
Establishing a 
dialogue with 
survey 
participants 
over email 
could put the 
lead 
researcher in 
a position 
where she is 
uncertain on 
how best to 
approach 
requests made 
As described above, most of the 
study will be administered via a 
separate email address to Robin’s 
personal USW email. However, the 
information sheet will direct 
participants to contact Robin 
(via her personal USW email 
address) with questions about the 
mechanics of completing the 
survey. If participants have any 
questions about anything else 
related to the survey such as 
Health & Her, the menopause, or 
concerns about the study, they 
2 
2 
4 The information sheet, which will be 
provided to participants prior to 
the undertaking the survey, will 
include a disclaimer which explains 
that no medical advice could be 
sought from the research team. A 
list of medical help resources will 
also be included in this information 
sheet, should any participants feel 
worried about their health following 
completion of the survey. This 
information will be repeated within 
the debrief sheet, at the end of the 
survey.  
On receipt 
of 
approval 
for 
methodolog
y (before 
surveys 
are made 
live) 

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requests 
that she is 
unable to 
grant.  
 
For example, 
participants 
will be 
answering 
health and 
medical type 
questions 
(i.e. “have 
your 
menopause 
symptom 
become 
better or 
worse?”). 
This may 
lead some to 
mistake the 
intent of 
the survey, 
and email 
the lead 
researcher 
to ask for 
medical 
advice.  
 
Participants 
might also 
email Robin 
wishing to 
complain to 
her if they 
do not meet 
the 
conditions 
for 
remuneration
, or they 
by survey 
participants, 
for example, 
survey 
respondents 
may request 
medical 
advice. 
Therefore, 
provisions 
will be made 
in the event 
that this 
occurs.  
Robin also 
could be 
approached by 
participants 
wishing to 
complain and 
pressurise her 
into providing 
remuneration 
for which they 
are not 
eligible, and 
control 
participants 
might feel 
disappointed 
that they were 
not given an 
opportunity to 
engage in the 
daily 
monitoring 
intervention, 
and they may 
approach Robin 
wishing to 
complain or 
pressurise her 
into 
will be directed to the Director 
of Studies (Dr Deborah Lancastle) 
in the first instance. 
Participants will be asked only 
to contact Robin with questions 
about procedural points. If 
participants have any questions 
about anything related to the 
survey (i.e symptom monitoring or 
the menopause) they will be asked 
to contact the Director of 
Studies: Dr Deborah Lancastle. If 
any participants have questions 
which are not related to the 
survey or if they have 
objections, then the lead 
researcher will consult with her 
supervisors and a joint decision 
will be made about the best way 
to solve the problem, with 
escalation to the USW research 
governance officer if this isn't 
solved satisfactorily. It will be 
clearly stated in the information 
sheet that the research team 
cannot provide medical advice and 
that any respondents who are 
concerned should contact their 
GP.  
 
In terms of complaints about 
eligibility for/claiming the 
voucher, the steps participants 
need to take to ensure they are 
eligible to claim the voucher are 
clearly stated on the information 
sheet and repeated in the debrief 
sheets, minimising the likelihood 
that participants could claim 
they didn’t know they had to 
satisfy certain criteria to be 
eligible for remuneration. 
Together, these controls should 
 
The information sheet and debrief 
forms, as well as all emails sent to 
participants, will include the terms 
and conditions for voucher 
eligibility: 
 
You will be emailed your £20 Amazon 
gift voucher within the next 24 
hours. Make sure you check your 
junk/spam folder if you have not 
received it after 24 hours, if you 
have still not received it please 
email 
robin.andrews@southwales.ac.uk. Only 
one £20 voucher will be provided 
per participant. Amazon vouchers 
will be sent to those 
who fully completed the research 
materials sent to them via email, 
did not withdraw from the study, and 
had accurately confirmed their 
username on each survey they 
submitted.   
  
“To be eligible for the voucher you 
must satisfy the following criteria:  
You must not withdraw or drop-out 
from this study  
You must complete and submit all 
surveys which are sent to you within 
the stated time periods. You will 
have had 24 hours to complete the 
follow-up survey.   
If you were allocated into the 
intervention group you must have 
completed the 5-minute surveys each 
day (within 24 hours of the survey 
being received via email) for 14 
days.  
You must have accurately confirmed 
your username on each survey you 
completed. Your username will remain 

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may be 
disappointed 
in their 
group 
allocation 
and request 
to be put 
into a 
different 
group. 
 
allocating 
them into the 
intervention 
group.   
 
 
 
minimise any chance of Robin 
experiencing negative 
consequences from any potential 
issues a participant might have 
with the research, and provide a 
clear protocol for action should 
problems arise.   
 
Participants who are disappointed 
with their group allocation will 
be reminded that their decision 
to engage in the study is 
voluntary and they are free to 
withdraw their data from the 
study at any point up until they 
receive their £20 Amazon voucher. 
They will be directed to read the 
information sheet which explains 
the importance of comparing the 
monitoring intervention group 
with a non-monitoring control 
group. On the third debrief 
sheet, which will be presented at 
the end of the final follow-up 
survey, all participants are 
given information on online tools 
and mobile apps which they can 
use to monitor their symptoms, 
should they wish.   
 
 
the same throughout the duration of 
this study and will be provided on 
all emails sent to you from the 
research team.” 
 
The third and final debrief sheet 
(see Appendix 30- Debrief 3 follow-
up survey) will include the 
following information to all 
participants:  
  
“Symptom monitoring tools:    
   
If you were allocated into the 
control group and did not get an 
opportunity to engage in the symptom 
monitoring intervention, please see 
the following online symptom 
monitoring tools and mobile apps. If 
you were in the intervention group 
but feel you have benefited from 
monitoring your symptoms and would 
like to continue you can also use 
the following online tools and 
mobile apps:    
   
Health & Her online symptom tool: 
https://healthandher.com/symptom-
tool/    
   
Health & Her mobile app (IOS & 
Googleplay): 
https://apps.apple.com/gb/app/health
-her-menopause-app/id1519199698    
   
Symptom checker from WebMD: 
https://symptoms.webmd.com/default.h
tm    
   
Clue (a free period tracker app on 
IOS only): https://helloclue.com/    
   
Flaredown (a free web and mobile app 

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Risk Evaluation 
Likelihood 
Given the control measures in place:  
Rating 
It is extremely unlikely to occur 
2 
It is not expect to happen 
4 
May occur under current circumstances 
6 
Likely to occur under current circumstances 
8 
Almost certain to occur under current circumstances 
10 
 
Severity 
Potential outcome:  
Score 
Minor first aid/ minor property damage/ minor inconvenience 
2 
First aid (e.g. sprains, cuts, bruises) / repairable property damage / some disruption to activities 
4 
Lost time injury / fracture fingers/toes / stay in hospital / replacement of property required / significant disruption 
to activities 
6 
Fractures (other than fingers/toes), amputations etc. / partial loss of a building / postponement of activities 
8 
Fatality / cancellation of activities / complete loss of a building  
10 
 
Risk Rating 
Less than 8 
Low Risk 
8 – 16 
Low – Medium Risk 
on Android & iOS): 
http://flaredown.com/”   
 

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20 – 32 
Medium Risk 
36 – 48 
Medium – High Risk 
Above 48 
High Risk