Hypnotic Intervention for Women With Chronic Pelvic Pain: a Pilot Randomised Control Trial
Phase: NA
Conditions: Chronic Pain, Pelvic Pain, Psychological, Hypnosis, Animal
Sponsor: University of South Australia

 
Date: 20/11/2020 
Hypnotic intervention for women with chronic pelvic pain: a pilot randomized 
control trial. 
NCT number: Not Available. 
Authors: 
Tiffany Brooks BPsych (Hons.) MPsych (Health) MAPS (Orchid ID: 0000-0003-
0277-4563)1,2 
Dr Rebecca Sharp BN, BHSc (Hons), Ph.D (Orchid ID: 0000-0003-3334-2990)1 
Dr Susan Evans (Orchid ID: 0000-0003-0347-604X) FRANZCOG 
FFPMANZCA3 
Sonia Scharfbillig BSc, BPhty (Hons), M Musc Sports Phsyio. (No orchid ID)4 
Dr John Baranoff B.Sc.(Hons.), MClinPsych, Ph.D (Orchid ID: 0000-0003-2339-
1895) 3,5 
Professor Adrian Esterman PhD MSc BSc (hons) FACE DLSHTM (Orchid ID 
0000-000107324-9171) 1 
1. The University of South Australia, 2. Aware Women’s Health in Adelaide, 
South Australia 3. University of Adelaide. 4. Pelvic Floor Health 5. Centre for 
Treatment of Anxiety and Depression. 
Correspondence to be sent to: 
Miss Tiffany Brooks 
257 Melbourne Street, NORTH ADELAIDE SA 5006 Email: 
brota010@mymail.unisa.edu.au 
 
 
 
 
 

 
 
Methods  
Ethics 
This study received approval from the University of South Australia Human 
Research Ethics Committee on 28th of August, 2020 (protocol number 
202935).  
 
Trial Registry  
Our pilot RCT protocol has been registered with the Australian and New 
Zealand Clinical Trials Registry28.  
 
Design 
The study design was a pilot RCT. This study followed the guidelines for pilot 
RCTs outlined in the Consolidated Standards of Reporting Trials (CONSORT) 
statement and 2010 extension.29-30 A parallel group design, with treatment 
and waitlist control groups, was utilized.  
 
Inclusion and exclusion criteria 
Our inclusion criteria required participants to be over the age of 18, female 
and with pain in the pelvic region of more than three months duration that 
was not attributable to an identified biological cause.2 Participants’ pelvic pain 
could not be solely due to pain during intercourse or periods, as these are 
regarded as separate groups within the research literature.   
 
Recruitment 

Recruitment was conducted between the dates of the 1st of October and the 
2nd of November, 2020. Participants in the intervention group commenced the 
education and hypnotic intervention on November 2nd, 2020. Participants 
were recruited directly online using the Pelvic Pain Foundation of Australia 
social media sites, and via health practitioners working with PPP, who 
provided study information to their clients. Participants who expressed an 
interest were contacted by email, and provided with the Participant 
Information Sheet and Consent Form. Once consent forms were received, 
participants were sent the questionnaires for the outcome measures.  
 
Allocation  
Participants were allocated to either the intervention or waitlist control 
groups. The intervention group received seven weeks of hypnotic intervention 
therapy in the form of audio recordings of hypnosis sessions provided online. 
The waitlist control group received no intervention.  
 
Blinding  
Blinding for participant or psychologist was not possible, as participants 
required notification of the time line for hypnotic intervention. A total number 
of 40 participants commenced the trial, with 20 allocated to the intervention 
group, and 20 allocated to a waitlist control. Participant details were placed 
into unlabelled, sealed, envelopes.  
 
Randomization 
Randomization was conducted using a basic randomization software template. 
Once group allocation was complete, participants were notified of their group 

allocation. The waitlist control group received support for two months upon 
completion of the trial. Recruitment and contact with participants were 
undertaken by the primary researcher, whereas randomization was 
undertaken by an independent statistician.  
 
Procedure 
After allocation, participants in the intervention group were sent a link to 
provide them with access to the hypnosis recordings when the trial 
commenced. The information sheet and seven hypnosis recordings were 
accessible on a website for the study.  The intervention also contained one 
session of education regarding PPP and hypnosis. Participants in the 
intervention group were instructed to read the health resources provided, 
that included information on the anatomy of the pelvis and the basics of pain 
education before commencing the hypnosis recordings. Intervention group 
participants then completed seven online hypnosis recordings, one per week 
for seven weeks.  
 
The intervention group were also instructed to continuing listening to 
recordings from the weeks prior whilst progressing through the intervention 
to week seven. The intervention group participants were contacted by phone 
or email once weekly during the trial, to discuss their progress and to seek 
feedback on their experience with the intervention.  Following the conclusion 
of the intervention at week seven, participants completed the outcome scales 
assessed at the beginning of the study, and provided feedback on the study 
overall.  The control group completed the concluding outcome measures at 
the same time. This occurred across the week of the 21st of December, 2020. 

The waitlist control were given access to the study materials including 
information on the anatomy of the pelvis and the basics of pain education, as 
well as the hypnosis sessions for two months after the study concluded. This 
was so that they could also have the benefits of the intervention, without 
interfering with the results. No changes to the study methodology were made 
once the pilot RCT commenced.  
 
Education  
Participants in the intervention group received education about the pelvis, 
pelvic muscles, pelvic pain and hypnosis prior to commencing the hypnotic 
intervention.10-11,12-14 This included information on pain and the brain, how to 
become familiar with the pelvic muscles, and how to tense and relax the pelvic 
muscles. The education components were heavily based on the ‘explain pain’ 
resources for chronic pain management by Moseley and Butler31 and 
consultation with two experienced physiotherapists.   
 
Hypnosis script development 
A series of seven hypnosis scripts were developed. This number was based on 
the number of scripts used in other evidence-based hypnosis protocols for IBS 
and chronic pain.26,32 These scripts were developed based on resources on 
script structure provided by Mason33 and Yapko.32 Induction is the process of 
preparing the person to go into a state where they are focused and more open 
to suggestion, called a ‘trance’ state. After promoting relaxation, every 
hypnosis script starts with an induction.32The inductions chosen for the script 
development in this study were based on a selection commonly used for 
hypnosis in general, as well as those used regularly with reference to chronic 

pain and IBS. The following sources were consulted with reference to the 
development of the inductions used for the scripts in this study.32-33  
 
The content of the scripts related to suggestions, deepening and metaphors 
were drawn from a number of sources. Two expert pelvic pain 
physiotherapists were consulted as to suggestions that they commonly used 
to assist women with PPP to relax their pelvic muscles. These suggestions 
were then included across the scripts. Suggestions were also drawn from 
emotional coping skills, relaxation techniques, and a technique to de-
catastrophize used in cognitive behavioural therapy for chronic pain 
management. Deepening exercises were drawn from those commonly used 
for hypnosis, using the Yapko32 and Mason33 resources. Both direct and 
indirect as well as pain specific and non-specific exercises have been shown to 
be effective for chronic pain-related hypnosis, therefore combinations of 
these were used across scripts.25 A brief overview of the individual scripts can 
be seen in Table 1 below. The scripts were examined for validity by an expert 
in the field.  
 
Table 1 
Brief descriptions of the seven scripts developed for the purposes of this study 
Script number  
Goal / script title 
Induction  
Deepening 
Metaphor 
Suggestions  
Suggestion type
1 
Change pain 
sensation to warmth 
Progressive 
Muscle 
Relaxation/ 
body scan 
Visualisation 
warm liquid 
and anatomy  
Melting, 
liquid 
Relax muscles, 
warmth, 
sensation change  
Indirect  
2 
Protected pelvis  
Diaphragm 
breathing  
Visualisation 
pelvic 
anatomy  
Protective 
barriers, 
Protected space  
Direct 
suggestions  

relaxed 
space  
3 
Adjust pain severity   
Eye 
induction  
Five senses 
exercise  
Dial  
Pain dial  
Direct and 
indirect  
4 
Anaesthesia  
Falling 
leaves  
Focus 
exercises  
Strengths  
Glove anaesthesia 
applied to the 
pelvis  
Direct and 
indirect  
5 
Apply previously 
acquired skills to 
pain management  
Candle 
induction 
Visualisation 
Transport 
Regression to 
retrieve skills  
Direct and 
indirect  
6 
Emotional self 
soothe, relax muscle 
tension 
Stairs  
Water 
visualisation  
Flowing 
water  
Notice flow of 
water, tension 
and unpleasant 
emotions float 
away  
Direct and 
indirect  
7 
De-catastrophizing  
Butterfly  
Forest 
visualisation  
Tracking 
flow of 
thoughts  
De-catastrophize, 
manage anxiety 
about pain 
Direct and 
indirect  
 
Outcome measures 
This study utilized a series of questionnaires at baseline and the conclusion of 
the pilot trial in line with the outcomes of interest. The outcome measures 
included the Generalised Anxiety Disorder Scale 7-item (GAD-7)34;, Patient-
Health Questionnaire 9-item (PHQ-9)35, 10-point Visual Analogue Scale 
measuring pain severity, Brief-COPE36, Pain Catastrophizing Scale (PCS)37, the 
Pain Disability Index (PDI)38 and the Short Suggestibility Scale (SSS)39 The 
questionnaires were converted to an online format using SurveyMonkey40 
software, then a link to the study website was emailed to participants. The 
questionnaires utilized are listed below.  
 
Feedback on recording use and the study 

The primary outcome was to establish the feasibility of the trial. Therefore, 
the intervention group was asked to provide weekly feedback on the 
recordings and study overall and at the end of the pilot trial. At baseline, we 
asked participants to give an overview of their experience with chronic pelvic 
pain in an open response dialogue box. Each week of the seven week trial, 
participants in the intervention group were asked how many times they 
listened to each recording and for their feedback. We also asked for feedback 
on the trial overall in an open dialogue box in the concluding measures.  
 
Questionnaires for the outcome variables   
Our primary outcomes of interest were anxiety and depression. The secondary 
outcomes of interest included perceived pain severity, life impact of pain, 
coping styles and pain catastrophizing. We identified our outcomes of interest 
from previous research on chronic pain, previous systematic reviews and a 
recent scoping review looking at predictors of mental health outcomes for 
women with CPP.11-14    
 
Generalised Anxiety  
Generalised Anxiety was measures using the GAD-734 at baseline and trial 
conclusion. The GAD-734 is a 7-item self-administered scale with seven 
questions related to Generalised Anxiety Disorder symptoms according to the 
Diagnostic and Statistical Manual 5th Edition (DSM-V).41 Persons completing 
the GAD-734 are asked ‘over the last two weeks, how often have you been 
bothered by the following problems’, before being presented with the seven 
questions about anxiety symptoms, such as ‘feeling nervous, anxious or on 
edge’. Each of the seven items has a four-point Likert response scale, with 

responses ranging from 0 (not at all) to 3 (every day). Total scores range from 
0 to 21, with a higher score representing greater anxiety.  
 
Depression  
The PHQ-935 was used to assess for depression severity at baseline and trial 
conclusion. The PHQ-935 contains 9 self-report questions related to depression 
according to the Diagnostic and Statistical Manuel 5th edition (DMS-5)41.  
Persons completing the PHQ-935 are asked ‘over the last two weeks, how often 
have you been bothered by the following’, and then asked the nine questions 
about depression symptoms such as ‘little interest or pleasure in doing things’.  
Each question is rated from 0 (not at all) to 3 (nearly every day), with total 
scores ranging from 0 to 27, with a higher score implying more depression.  
 
Pain severity  
Participants were asked to rate their current pain severity on an 10-point 
Visual Analogue Scale where 0 represented no pain, and 10 represented the 
most severe pain imagined  at baseline and at the conclusion of the pilot trial.  
Coping styles 
Coping styles were assessed using the Brief-COPE.36 The Brief-COPE36 is a 28-
item self-report questionnaire designed to assess the efficacy of coping styles. 
Each item is rated on a scale of 1 (I haven’t been doing this at all’) to 4 (I’ve 
been doing this a lot).The scale is often used with patients adjusting to 
significant diagnoses.36  There are two subscales included in the 28-item 
questionnaire, avoidant and approach coping, as well as 4 questions about 
humour and religion. The Avoidant coping subscale is composed of 12 
questions (items 1, 3, 4, 6, 8, 9, 11, 13, 16, 19, 21, 26), and reflects coping 

using denial, substance use, self-blame and self-distraction. The approach 
coping subscale is composed of 12 questions (items 2, 5, 7, 10, 12, 14, 15, 17, 
20, 23, 24, 25), and is reflective of coping using active skills, positive planning, 
acceptance, seeking emotional and informative supports. The total score on 
each of the two subscales ranges from 12 to 48. We administered the Brief-
COPE to establish avoidant and active coping style scores at baseline and the 
end of the pilot trial.  A higher score represents a greater use of the coping 
style. 
 
Pain Catastrophizing 
The Pain Catastrophizing Scale37 was used to assess for pain related anxiety. 
The PCS37 is a 13-item self-report measure with persons completing the scale 
asked to rate their response from 0 (not at all) to 4 (all the time). The total 
score on the PCS37 ranges from 0 to 52. The items on the PCS are reflect 
rumination about pain, the extent people magnify their pain and feel helpless 
to manage their pain. Example questions include ‘I can’t stop thinking about 
how much it hurts’, I am afraid that something serious might happen’ and 
‘there is nothing that I can do to reduce the intensity of my pain’. A higher 
score reflects greater pain catastrophizing. Permission to use the PCS for 
student research purposes was sought and granted by Mapi Research Trust42 
on the 14th of May, 2020. The PCS was administered at baseline and study 
conclusion.  
 
Pain-related disability  
The PDI38 is a self-report questionnaire used to assess pain-related disability. 
The PDI38 was designed to establish the extent to which pain disrupts life 

across seven domains. These include: family and home responsibilities, 
recreation, social activity, occupation, sexual behaviour, self-care and life-
support activities. People completing the PDI rate the extent that pain has 
impacted them on each of these seven domains on an 11-point numerical 
scale of 0 (no disability) to 10 (worst disability). The seven items can be added 
together to form a total score for pain related disability with range from 0 to 
70, a higher score reflecting more disability.  
 
Suggestibility  
It is widely known that response to hypnosis can be dependent on 
suggestibility. Therefore, we wanted to know how suggestible our participants 
were and whether this impacted on the results. The SSS39 was therefore 
administered at baseline. The SSS39 is a 21-item self-report scale designed to 
establish suggestibility. Persons completing the SSS are asked to rate the 
questions as ‘to what extent the following statements relate to you’ on a scale 
of 1 (not at all/very slightly) to 5 (a lot). Total scores range from 21 to 105. A 
higher score reflects greater suggestibility. 
 
Statistical analyses 
The results of the questionnaires in the online SurveyMonkey40 format were 
converted to an SPSS data file. SPSS43 was used to provide baseline descriptive 
statistics for the control and intervention groups. Independent sample t-tests 
were then conducted in order to establish participant results for the outcomes 
of interest pre and post intervention. The comparison of group differences 
over time was undertaken using linear mixed effects modelling with group, 
time and group time interaction. Group time interaction was included in the 

model as the formal test for the efficacy of the intervention. Linear mixed 
effects modelling was conducted using Stata statistical software.44 A second 
model including suggestibility was then undertaken. Results were considered 
statistically significant at p<0.05. 
 
Sample size justification  
Power calculations for the study were carefully considered. Current 
recommendations for pilot RCT sample sizes vary significantly, as they are by 
definition investigative in nature and the standardized effect size is unknown. 
For a main trial planned with 90% power and two-sided 5% significance in 
mind, Whitehead et al.45 recommend a minimum of 10 participants per study 
arm in the pilot trial.