Reducing the Experience of Menopausal Symptoms Through Temperature (REST)
Phase: NA
Conditions: Hot Flashes, Menopause
Sponsor: Wake Forest University Health Sciences

REST: Reducing the Experience of Menopausal Symptoms through Temperature 
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NCT03937466 
 
Date of IRB Approval:  4/22/20 
 
Study Title: Reducing the Experience of menopausal Symptoms through Temperature (REST) 
 
Principal Investigator: Nancy E. Avis, PhD 
 
Co-investigators: Beverly Levine, PhD, Remy Coeytaux, MD, PhD 
 
Study Team: Alexandra Dest, MPH, Mary McLendon, Staci King 
 
Sponsor or funding source: Internal Funding from the Center on Integrative Medicine 
  

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Table of Contents 
 
Study Schema.................................................................................................................................. 3 
Background, Rationale and Context ............................................................................................... 4 
Objectives ....................................................................................................................................... 5 
Participant Selection ....................................................................................................................... 6 
Recruitment ................................................................................................................................ 6 
Inclusion Criteria ........................................................................................................................ 6 
Exclusion Criteria....................................................................................................................... 6 
Study Outcomes and Measures ....................................................................................................... 6 
Study Outcomes ......................................................................................................................... 6 
Measures .................................................................................................................................... 6 
Measures Timeline ..................................................................................................................... 8 
Study Plan ....................................................................................................................................... 8 
Design ........................................................................................................................................ 8 
Setting ...................................................................................................................................... 10 
Informed Consent ..................................................................................................................... 10 
Confidentiality and Privacy ..................................................................................................... 10 
Data and Safety Monitoring ..................................................................................................... 11 
Reporting of Unanticipated Problems, Adverse Events or Deviations .................................... 11 
Statistical Considerations .............................................................................................................. 11 
Analytical Plan ......................................................................................................................... 11 
Sample Size .............................................................................................................................. 12 
Covariates ................................................................................................................................. 12 
Appendices .................................................................................................................................... 13 
References ..................................................................................................................................... 14 
 
 

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Study Schema 
 
 
 
Recruitment & Telephone Screener
Consent & Baseline Data Collection 
Assessments: PSQI, HFRDIS, CESD-10, GAD-7, SF-36, Sociodemographics, SSAS, Health 
History and Current Medications, & Health Behaviors
Hot Flash Frequency Assessment 
To be eligible, participants must record at least 4 hot flashes per day on average over 2 weeks 
Assessment: DDHF for two weeks- mailed back to study team
Research Visit 
If still eligible based on two weeks of DDHF, participants will receive cooling mattress pad
either at PHS research center or other mutually agreed upon location. 
Adjustment Period  (one week)
Participants will have one week to adapt to use of cooling mattress pad and determine optimal 
settings for sleep. 
Assessments: DDHF
Intervention Period (eight weeks) 
Assessments: DDHF
Follow-Up Data Collection
Assessments: PSQI, HFRDIS, CESD-10, GAD-7, SF-36, Medications, Updated Health Behaviors. 
Evaluation of intervention 

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Background, Rationale and Context 
Menopause, or the irreversible cessation of menses, occurs with the depletion of ovarian follicles 
and an associated decline in estrogen secretion. The full extent of the neuroendocrine events 
surrounding the menopause is not completely understood, but hot flashes and/or night sweats as 
distinct manifestations of such events are commonly experienced by 64% to 87% of women 
undergoing natural menopause and almost all women who undergo surgical menopause.1-4 Hot 
flashes are “transient episodes of flushing, sweating, and a sensation of heat, often accompanied 
by palpitations and a feeling of anxiety, and sometimes followed by chills.”5 They are prevalent 
in women in their 40s and 50s 3 and frequently begin in the early perimenopausal period and 
peak just prior to a woman’s last menstrual period.6,7 About 1/3 of women experience more than 
10 hot flashes per day, usually lasting 1 to 5 minutes with a small percentage continuing for more 
than 6 minutes.3  
 
While some women report experiencing the menopausal transition without any hot flashes1, for 
other women, these symptoms can be frequent and severe enough to become debilitating and 
interfere with daily activities and quality of life.8-16 Avis et al.8 found that women reporting hot 
flashes or night sweats were significantly more likely to experience depressive symptoms (O.R. 
= 1.83), even controlling for sleep problems and estradiol levels. Hot flashes are one of the chief 
menopausal complaints for which women in Western societies seek medical treatment5,17 and are 
the primary reason that women begin hormone therapy (HT).18-21 
 
Estrogen therapy, alone or in combination with progesterone, is currently the gold standard for 
treatment of vasomotor symptoms. A Cochrane Database systematic review of 21 double-blind, 
placebo controlled trials showed a mean reduction from HT of approximately 17 hot flashes per 
week (equivalent to a mean reduction of 2.4 hot flashes per day or 75%) with HT compared to 
placebo.22 HT, however, is associated with a number of risks and is often contraindicated for 
women at high risk for breast cancer.23-25 Some of the risks of HT include thromboembolic 
events and breast cancer, as well as troublesome side effects, like breast tenderness and irregular 
bleeding. The Women’s Health Initiative (WHI) trial and the HERS study have demonstrated 
increased coronary heart disease events and stroke in HT users26-28 and a doubling of risk of 
dementia in the WHI combination HT group when compared to the placebo group.29 A clear 
increase of breast cancer risk was present after 4 years of HT use.26 Following publication of the 
WHI results, many women stopped HT. One study found that among women who had 
discontinued HT, 25% ultimately resumed therapy because of symptoms. This finding suggests 
that there are some women for whom symptoms are so severe that they are willing to take HT 
despite the risk of long-term health consequences.30  
 
Given the risks and side effects associated with HT, many women either cannot or choose not to 
take HT 3,10,25,31, and many women have sought alternatives to HT.5,32-34 A telephone survey of 
886 women aged 45-65 found that 22% used alternatives to HT to manage menopausal 
symptoms.35 These alternatives include other pharmaceutical agents, herbal or dietary remedies, 
and behavioral therapies. Many of the pharmaceutical agents are ineffective or have a high 
incidence of side effects. Clonidine, an alpha-2 adrenergic agonist, is of limited efficacy and can 
cause hypotension as an adverse effect.36,37 Fluoxetine and venlafaxine, two antidepressants may 
cause disturbing side effects such as dry mouth, anorexia, nausea, constipation, anxiety, 
sweating, insomnia, and decreased libido.38 Veralipride is a dopamine antagonist which is 

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indicated for the treatment of hot flashes, but can have central nervous system, endocrine or 
respiratory side effects.39 Bellargal® is not very effective in reducing hot flashes and has side 
effects including sedation and constipation.  
 
With many of the prescription medications having limited efficacy and multiple side effects, 
women have turned to over the counter "natural" products to treat menopausal symptoms.32,33,40 
These products include St. John’s wort, vitamin E, black cohosh, dong quai, ginseng, evening 
primrose oil, motherwort, licorice, wild yam, red clover, and soy derivatives.41 Black cohosh has 
been found to have a modest effect on hot flashes in trials lasting six months or less. Although 
few adverse events have been reported, the long-term safety (mainly estrogenic stimulation of 
the breast or endometrium) is unknown and not enough data exist to support a recommendation 
for its use in this country.42 Soy is a popular alternative for relieving hot flashes, but the evidence 
for its effectiveness is mixed.43-45 A 12-week double-blind cross-over design clinical trial found 
no evidence that soy was more effective than placebo.45 Burke et al.44 also did not find beneficial 
effects of soy. Although soy markedly diminished moderate to severe hot flashes in a double-
blind, placebo-controlled trial of 104 postmenopausal women, side effects such as 
gastrointestinal problems, food intolerance, and constipation were experienced by a significant 
number of participants.46 Two reviews of randomized controlled clinical trials of complementary 
and alternative medicine (CAM) therapies for hot flashes did not find evidence that other herbs 
and nutritional supplements evidence were beneficial.41,47 Many of these alternative therapies 
have not been shown to be effective and are not regulated by the Food and Drug Administration. 
A further problem is that the identity of the compounds and the mechanism of action are 
unknown.41  
 
We have previously conducted three trials of nonpharmacological treatments for hot flashes.  
Two of these trials were of acupuncture48,49 and one trial was of yoga.50 Although all three 
studies found a significant reduction in hot flashes, women continue to seek other 
nonpharmacological interventions for their night sweats and hot flashes. A cooling mattress pad 
system provides a promising device for reducing hot flashes. The devise consists of a mattress 
pad that is placed between a person’s mattress and fitted sheet. Small tubes are embedded in the 
pad that are connected to a cube that is filled with water and kept next to the bed. Participants 
can regulate the temperature of the cooling mattress pad by regulating the temperature of the 
water that flows from the cube to the mattress pad. This is a totally non-invasive device that 
provides a cooling temperature for sleeping.  We hypothesize that the cooling mattress pad will 
help women sleep and reduce their number of night sweats.  It’s possible that it may also reduce 
the number of daytime hot flashes.  
Objectives 
Objective 1: To obtain preliminary evidence on the efficacy of a cooling mattress pad in 
reducing subjective hot flashes for peri and postmenopausal women experiencing 
menopausal hot flashes.  
 
Objective 2: To obtain preliminary evidence on the efficacy of a cooling mattress pad for 
improving sleep for peri and postmenopausal women experiencing menopausal hot flashes. 

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Participant Selection 
Recruitment 
Women will be recruited from the community through flyers (Appendix A). They will call 
into a study phone line or respond through Be Involved at which time they will be screened 
for their initial eligibility using a telephone screener (Appendix B). Women who are eligible 
and willing to participate, will come to the PHS Research Center in Piedmont Plaza 1 or the 
Center for Integrative Medicine in Piedmont Plaza II to be consented and complete baseline 
questionnaires or sent materials via mail or email to complete. They will be sent home or 
givena hot flash diary to complete for two weeks in order to confirm a sufficient number of 
hot flashes for study eligibility. After two weeks, women will mail back their diaries and 
continue to record their daily hot flashes until they are notified by study staff of their 
eligibility, within a week of receiving the diary. 
Inclusion Criteria 
• Women aged 45-60 
• Peri or postmenopausal women (No periods for at least 3 months) 
• Experiencing at least 4 hot flashes per day on average per week 
Exclusion Criteria 
• Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks. 
• Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 
weeks. 
• Initiated antidepressants in the last 3 months. 
• Changed their dose of an antidepressant in the last 3 months. 
• Women who describe their health as fair or poor. 
Study Outcomes and Measures 
Study Outcomes 
• Primary Outcome Measure: change in frequency of daytime and nighttime hot 
flashes based on a daily diary completed every day. 
• Secondary Outcome Measure: Improved sleep quality, as measured by the 
Pittsburgh Sleep questionnaire. 
Primary Measure 
• Hot Flash Diaries: All women will complete daily hot flash diaries from the time 
of their baseline visit through follow up. They will record the number and severity 
of their hot flashes on the daily hot flash calendar (Appendix C). 
Secondary Measure  
• Pittsburgh Sleep Quality Index (PSQI): Sleep will be assessed using the PSQI, 
a well validated commonly used self-report sleep measure. The PSQI includes 19 
questions on sleep quality in the last month. It provides an overall sleep quality 
score and sub-scores for subjective quality, latency, duration, efficiency, 

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disturbances, use of sleep medications, and daytime dysfunction due to sleepiness. 
The global score ranges 0 to 16, with score >5 indicating poor sleep quality and 
high sleep disturbance (Appendix D). 
Tertiary Measures  
• The Hot Flash Related Daily Interference Scale (HFRDIS): Hot flash 
interference will be assess using HFRDIS, a 10-item psychometrically sound 
measure for assessing the impact of vasomotor symptoms on daily activities and 
overall quality of life. This validated tool assesses the impact of hot flashes on 
overall quality of life and 9 specific domains within the past week (work, social 
activities, leisure activities, sleep, mood, concentration, relation with others, 
sexuality, and enjoyment of life) (Appendix E). 
• Center for Epidemiologic Studies Depression (CESD-10): Depressive 
symptoms will be assessed using the CESD-10, a 10-item scale asking about 
depressive symptoms in the last week. The CESD is a commonly used measure 
with established reliability and validity (Appendix F). 
• General Anxiety Disorder (GAD-7): Anxiety symptoms will be measured with 
the GAD-7, which consists of 7 items, each describing a common symptom of 
anxiety. The respondent rates how much he or she has been bothered by each 
symptom over the past two weeks on a 4-point scale ranging from 0 to 3. Higher 
scores indicate more anxiety (Appendix G). 
• Health-Related Quality of Life (HRQL): HRQL will be measured with the 
Medical Outcomes Survey Short-Form. This is an extensively used and validated 
36-item general HRQL scale. Its 8 subscales include physical function, social 
function, role limitations due to physical health, role limitations due to emotional 
problems, bodily pain, vitality, mental health and general health perceptions 
(Appendix H). 
• Somatosensory Amplification Scale (SSAS): SSAS is a 10-item questionnaire 
that assesses sensitivity to a range of uncomfortable bodily sensations and 
physiologic states which are not typically symptoms of disease. (Appendix J) 
• Health Behaviors: include standard questions on smoking and physical activity.  
Active smoking will be ascertained from the American Thoracic Society 
questions, Physical activity will be measured using 3 items (Appendix L). Change 
in health behaviors will be measured at the follow-up visit (Appendix N). 
• Evaluation of Intervention: This investigator developed questionnaire will 
assess acceptability of intervention (Appendix M) 
 
 
 

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Measures Timeline 
Variable 
Measure 
Appendix 
Baseline 
Daily for 
11 weeks 
Follow-
up 
Hot Flash Diary 
DDHF  
C 
X 
X 
 
Sleep 
PSQI  
D 
X 
 
X 
Hot Flash 
Interference 
HFRDIS  
E 
X 
 
X 
Depression 
CESD-10 
F 
X 
 
X 
Anxiety 
GAD-7 
G 
X 
 
X 
Health-related quality 
of life 
SF-36  
H 
X 
 
X 
Sociodemographics  
Investigator 
developed 
I 
X 
 
 
Symptom sensitivity 
Somatosensory 
Amplification Scale 
(SSAS)  
J 
X 
 
 
Health History and 
Current Medications 
Investigator 
developed 
K 
X 
 
 
Health Behaviors 
Investigator 
developed 
L 
X 
 
 
Evaluation of 
Intervention 
Investigator 
developed 
M 
 
 
X 
Change in Health 
Behaviors 
 
N 
 
 
X 
Medications Updated 
 
O 
 
 
X 
 
Study Plan 
Design  
We will conduct a non-randomized study of 24 peri or postmenopausal women aged 45-60 
experiencing at least 4 hot flashes/night sweats/day on average to evaluate their hot 
flashes/night sweats while using the cooling mattress pad for 8 weeks. The device consists 
of a mattress pad that is placed between a person’s mattress and fitted sheet that is connected 
to a cube that is filled with water and kept next to the bed. Participants can regulate the 
temperature of the cooling mattress pad by adjusting the temperature of the water that flows 
from the cube to the mattress pad. This is a totally non-invasive device.   
 
Women will be recruited from the community through advertisements and initially screened 
over the telephone. They will be screened for age, menopause status, and average number of 
hot flashes per day. Those women who are eligible based on the telephone screen, will be 
invited to come to the Public Health Sciences (PHS) Research Center in Piedmont Plaza 1 or 
the Center for Integrative Medicine in Piedmont Plaza II for a baseline interview.  At that 
time they will provide informed consent to participate in the study, complete several 

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questionnaires, and sent home with a 2-week diary to confirm their eligibility with respect to 
number of hot flashes/night sweats. If it is not possible for the participant to come to one of 
these locations, the baseline questionnaire and consent will be sent to the participant to be 
completed at home and mailed back. Two copies of the consent form will be sent to the 
participant. After received, a study team member will speak with the participant to present 
the elements of consent, the content of the study, and answer any questions. At the end of 
the discussion, the participant will be advised to sign and date one form and return it. The 
second form should be kept by the participant for documentation. Upon receipt of the signed 
form, the study team member will sign and date with the current date, and add a note 
detailing the date discrepancy. 
 
.We will ask participants to keep a record of their hot flashes throughout the day by either 
using a counter app on their phone or maintaining a paper log. After two weeks, women will 
mail in their diaries and continue to record their daily hot flashes until they are notified by 
study staff of their eligibility, within a week of receiving the diary.  
 
If still eligible based on the 2-week diary, participants will return to the PHS Research 
Center to receive a cooling mattress pad and container of distilled water (used to fill cooling 
mattress pad) to take home and use for the next 9 weeks. If it is not possible for the 
participant to return to the Research Center, the Chilipad will be delivered to the participant 
at a mutually agreed upon location. We will allow one week for women to determine the 
optimal temperature of the cooling mattress pad and the next 8 weeks for the data collection 
of hot flashes/night sweats while using the cooling mattress pad. Some participants may be 
away from home and unable to use the cooling mattress pad while participating in the study. 
We will ask that participants indicate on the Hot Flash Diary whether or not they used the 
cooling mattress pad the prior night and continue tracking their hot flashes/night sweats even 
if they did not use the mattress pad. 
Participants will mail in their completed Hot Flash Diary every two weeks in a pre-stamped 
and pre-addressed envelope to ensure that data is being consistently recorded.  
 
At the end of the 9 weeks, women will return to the Research Center or Center for 
Integrative Medicine, complete additional questionnaires and receive compensation for 
participating in the study. Participants may also complete the follow-up questionnaires by 
telephone or mail.  Analyses will assess frequency of hot flashes/night sweats experienced 
by women before and after using the cooling mattress pad. We will use an historical control 
group to compare results from this study to a control group from a previous study.  
Cooling Mattress Pad 
The ChiliPad™ cooling and warming system allows adjustments to be made to your bedding 
surface. The ChiliPad is placed on top of the mattress and an elastic strap is used to hold it in 
place. The fitted sheet is placed over the ChiliPad. The ChiliPad is connected to the ChiliPad 
Cube through the tail pipe, which can be placed either at the head or foot of the bed.  
 
Before the first use, the ChiliPad reservoir must be filled with distilled water. Once it is full, 
you must turn the Cube on so that water begins circulating through the mattress pad. As the 
water is circulating through the ChiliPad, you must continue to fill the reservoir.  

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The Cube cools or warms water to your set temperature and circulates it through the pad, 
generally achieving temperatures to a cool 55 F (13 C) and to a very warm 110 F (43 C). 
The temperature can be set either on the Cube or through the remote. 
 
The ChiliPad is not an FDA approved device. It does not pose the potential for serious risk 
to health, safety or welfare of study participants. For the purposes of this study, the device is 
being used to assess its impact on frequency of daytime and nighttime hot flashes and 
quality of sleep.  
Setting 
Women will be recruited from the community through flyers and advertisements and 
initially screened over the telephone. They will be screened for age, menopause status, and 
average number of hot flashes per day. Those women who are eligible based on the 
telephone screen, will be invited to come to the PHS research center located on the first floor 
of PPI or the Center for Integrative Medicine on the 5th floor of PP II for a baseline 
interview. If it is not possible for the participant to come to one of these locations, the 
baseline questionnaire and consent will be sent to the participant to be completed at home 
and mailed back. 
Participant Payments 
Study participants will each receive a $25.00 gift card at the end of the study and will be 
allowed to keep the mattress pad upon completion of the study. 
Informed Consent 
Study staff will obtain signed informed consent from each study participant at baseline visit. 
A study investigator will explain the study and allow patients to ask questions. 
Risks 
This study involves minimal risk to participants. During the time the participant is using the 
cooling device, their hot flashes may stay the same, decrease, or increase. Participant’s 
sleep, mood and quality of life may improve, worsen, or stay the same. Participants may feel 
anxious about answering questions about their well-being, sleep, or menopausal symptoms.  
 
The only risks associated with the cooling device are the following: 1) the possibility of 
disrupted sleep until you find the temperature that works best for you and the noise of the 
small fan, 2) the possibility of tripping if you do not place the cube properly, and 3) the 
possibility of risk of mold or mildew on the mattress pad if unwashed after several months.  
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that 
could directly identify subjects, and maintaining all study information in a secure manner. To 
help ensure subject privacy and confidentiality, only a unique study identifier will appear on 
the data collection form. Any collected patient identifying information corresponding to the 
unique study identifier will be maintained on a linkage file, store separately from the data. 

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The linkage file will be kept secure, with access limited to designated study personnel. 
Following data collection subject identifying information will be destroyed, consistent with 
data validation and study design, producing an anonymous analytical data set. Data access 
will be limited to study staff. Data and records will be kept locked and secured, with any 
computer data password protected. No reference to any individual participant will appear in 
reports, presentations, or publications that may arise from the study. 
 
All participants will be given an ID number that will be used on all forms. Names and 
telephone numbers associated with the IDs will be separate from all questionnaires and kept 
in a locked file.  
Data and Safety Monitoring  
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants. The principal investigator will be assisted by other members of 
the study staff. All team investigators have completed their institution’s courses for 
Protection of Human Research Subjects and will maintain up to date certification throughout 
the study period. 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any adverse events, deviations, or protocol changes will be reported to the IRB by the 
principal investigator or designated member of the research team. In addition any 
unanticipated problems, serious and unexpected adverse events, will be reported by the 
principal investigator or designated member of the research team to the IRB and FDA. 
Statistical Considerations 
Analytical Plan 
Our primary outcomes of interest will be change in number of daily hot flashes (total, 
daytime, and nighttime) over the eight week period. We will model our outcome in both 
absolute terms (average number of daily hot flashes each week) as well as in terms of 
percentage change in average daily hot flashes measured from baseline. We will first 
conduct a simple t-test on the difference in average number of daily hot flashes at baseline 
and eight weeks to see if this average difference is significantly different from the null value 
of zero. We will also conduct repeated measures models with time included as ordinal week 
(0-9) and the dependent variable pertaining to average daily number of hot flashes for each 
week or percent change in average daily number of hot flashes for each week. In the 
simplest repeated measures models we will examine whether the parameter estimate for 
week is significantly different from zero. We will also examine the effects of covariates such 
as age and menopause status to determine which are significantly associated with the 
outcomes, and to estimate an adjusted (least squares mean) outcome measure that will serve 
as an accurate comparison to our historical control (see below). 
 
Secondarily, we will model the continuous outcome of the total PSQI sleep score, as well as 
the subscores, using a similar repeated measures approach to that described above 
 

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In addition to examining, within our sample of cooling mattress pad users, the question of 
whether symptoms (hot flashes, sleep disturbance) improve over time, we will also compare 
any observed improvements with those found in our control group from the Acupuncture in 
Menopause (AIM) Study49 to see if cooling mattress pad users experienced significantly 
different levels of change over time compared to an historical control. (We note that in our 
AIM control group, there was on average an approximately -3.3% decline in average 
number of daily hot flashes from baseline to week 8, and there was an increase of .49 in total 
score on the PSQI over the same period.) 
Sample Size 
This is a single site, single arm pilot study designed to obtain preliminary evidence that the 
cooling mattress pad can help reduce hot flashes and night sweats. We will compare results 
to historical controls from a previous study. Based on this previous study,49 we estimate that 
women recruited to our sample will be experiencing, on average, approximately 10 hot 
flashes at baseline.  The average decline in number of daily hot flashes over an 8 week 
period in the control arm of this study was 0.36 (standard deviation 2.85). In comparison to 
the 0.36 fewer hot flashes on average in the absence of intervention (i.e., null hypothesis), 
we will be able to detect in our sample of 24 a decline of 2.1 in absolute number of average 
daily hot flashes from baseline to week 9, with 80% power and a two-tailed alpha of 0.05. 
We note that the ‘detectable’ anticipated decline of 2.1 in number of hot flashes (or just over 
20% decline from baseline) is a conservative estimate; in our previously-sited study,49 a 
35% decline in number of hot flashes over 8 weeks has been observed.   
Covariates 
In addition to sociodemographics (Appendix I) (age, education, marital status, employment 
status), the following covariates will be assessed: 
• Symptom Sensitivity is a measure of symptom sensitivity or amplification. The 
Somatosensory Amplification Scale (SSAS) is a 10-item questionnaire that 
assesses sensitivity to a range of uncomfortable bodily sensations and physiologic 
states which are not typically symptoms of disease. The SSAS has been shown to 
prospectively predict persistence of hypochondriacal symptomatology in transient 
hypochondriacal patients. This measure has been shown to be a strong predictor 
of vasomotor symptom reporting. It is included as a covariate because it is highly 
related to symptom reporting and symptom sensitivity may be an important 
variable related to treatment efficacy (Appendix J). 
• Health history and current medications. At the baseline visit, participants will 
be asked to bring in all medications, vitamins, and herbal supplements they are 
currently taking so that these can be recorded (Appendix K). Medications will 
again be assessed at follow-up (Appendix O). 
• Health behaviors will include standard questions on smoking and physical 
activity. Active smoking will be ascertained from the American Thoracic Society 
questions, Physical activity will be measured using 3 items we have used in 
previous studies (Appendix L). Change in health behaviors will be assessed 
(Appendix N) 

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Appendices 
Appendix A 
Study Flyer 
Appendix B 
Telephone Screener 
Appendix C 
Hot Flash Diaries 
Appendix D 
Pittsburgh Sleep Quality Index (PSQI): 
Appendix E 
The Hot Flash Related Daily Interference Scale (HFRDIS) 
Appendix F 
Center for Epidemiologic Studies Depression (CESD-10) 
Appendix G 
General Anxiety Disorder (GAD-7) 
Appendix H 
Health-Related Quality of Life (HRQL) 
Appendix I 
Sociodemographics 
Appendix J 
Somatosensory Amplification Scale (SSAS) 
Appendix K 
Health History and Current Medications 
Appendix L 
Health Behaviors  
Appendix M 
Evaluation of Intervention 
Appendix N 
Change in Health Behaviors  
Appendix O 
Medications Updated 
 

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References 
 
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Avis NE, Crawford SL, McKinlay SM. Psychosocial, behavioral, and health factors 
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