Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000368639p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2023
Date registered
13/04/2023
Date last updated
13/04/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized E-Hypnotherapy for Chronic Pelvic Pain Syndrome Trial (REST)
Scientific title
A randomised controlled trial comparing the influence of e-Hypnotherapy on pain, quality of life and healthcare costs in people with chronic pelvic pain syndrome
Secondary ID [1] 309069 0
Nil known
Universal Trial Number (UTN)
Trial acronym
REST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain 329140 0
Condition category
Condition code
Reproductive Health and Childbirth 326117 326117 0 0
Menstruation and menopause
Oral and Gastrointestinal 326521 326521 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 326522 326522 0 0
Crohn's disease
Renal and Urogenital 326523 326523 0 0
Other renal and urogenital disorders
Renal and Urogenital 326524 326524 0 0
Pelvic inflammatory disease
Anaesthesiology 326525 326525 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is e-Hypnotherapy: participants randomised to e-Hypnotherapy will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) and hypnosis education. Education will consist of information regarding pathophysiology of the pain process, specifically chronic pelvic pain, along with the impact that complimentary therapies such as hypnotherapy can have on pain. Education will be delivered via the website and will consist of short videos, animations and informative text sections to read. Following week one education, participants will need to listen to e-Hypnotherapy recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours.

The active control is relaxation: participants randomised to relaxation will first receive one session of Chronic Pelvic Pain Syndrome (CPPS) similar to the hypnosis. Following week one education, participants will need to listen to relaxation recordings at least once a week for seven weeks. The group will also be instructed to continue listening to recordings from the weeks prior whilst progressing. Each weekly recording will go for approximately one hour, with the total weekly time commitment being no more than three hours.
Intervention code [1] 325520 0
Behaviour
Intervention code [2] 325521 0
Lifestyle
Intervention code [3] 325522 0
Treatment: Other
Comparator / control treatment
The control treatment in this study will be waitlist: participants randomised to the waitlist arm will receive their usual care (e.g. pelvic pain specialist, pharmaceutical treatment, physiotherapy, complimentary medicines, etc) and will receive e-Hypnotherapy at the end of the testing period (12 months post-randomization).
Control group
Active

Outcomes
Primary outcome [1] 333986 0
The primary outcome measure will be pain severity at post-treatment (8 weeks) measured by the Brief Pain Inventory (BPI), which has good validity and reliability
Timepoint [1] 333986 0
8 weeks (primary outcome), 6 months and 12 months post-intervention
Secondary outcome [1] 418949 0
The secondary outcome measures include: Pain Interference as assessed with the Brief Pain Inventory (BPI)
Timepoint [1] 418949 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [2] 418950 0
Quality of Life (QOL) will be measured with the EQ5D5L
Timepoint [2] 418950 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [3] 418951 0
Psychological symptoms will be measured by the Depression Anxiety Stress Scale (DASS-21)
Timepoint [3] 418951 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [4] 418952 0
Fatigue will be measured by the Fatigue Symptom Inventory (FSI)
Timepoint [4] 418952 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [5] 418953 0
Sleep quality will be measured with the Jenkins Sleep Scale
Timepoint [5] 418953 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [6] 420399 0
Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS)
Timepoint [6] 420399 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [7] 420400 0
Self-efficacy will be measured with the Pain Self-Efficacy Questionnaire (PSEQ).
Timepoint [7] 420400 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [8] 420401 0
Health utilisation and cost data will be collected via a patient health service utilisation and employment questionnaire administered at all time-points.
Timepoint [8] 420401 0
8 weeks, 6 months and 12 months post-intervention
Secondary outcome [9] 420402 0
Acceptability of e-Hypnotherapy and Relaxation: will be measured with a treatment satisfaction scale at 8-weeks
Timepoint [9] 420402 0
8 weeks post-intervention
Secondary outcome [10] 420403 0
Safety of e-Hypnotherapy and Relaxation: will be established with weekly check-ins by the trial manager to understand whether any adverse events (e.g., increased anxiety) have occurred.
Timepoint [10] 420403 0
Weekly throughout 8-week intervention
Secondary outcome [11] 420404 0
Suggestibility in e-Hypnotherapy participants will be assessed using the Short Suggestibility Scale (SSS) and include in our sensitivity analyses.
Timepoint [11] 420404 0
Weekly throughout 8-week intervention

Eligibility
Key inclusion criteria
- Patients diagnosed with CPPS with persistent pain for at least 6 months, supported by a letter from treating physician or other evidence confirming the above.
- At least 18 years of age.
- Capacity to provide informed consent.
- English speaking, or sufficient level of English to understand the trial intervention, answer relevant questionnaires and participate in a group context.
- Access to internet.
- Residing in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- High risk of harming self or others.
- Severe mental illness (e.g., schizophrenia, severe depression).
- Significant cognitive impairment (the former three criteria confirmed by psychological screening by our psychology team or treating physician).
- Inability to read or write.
- Inability to speak or understand English.
- Currently pregnant.
- Currently or in the past received hypnotherapy.
- Have contraindications for hypnotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned (1:1:1 ratio) to e-Hypnotherapy, relaxation or waitlist control. A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses will be conducted on an intention-to-treat basis. A detailed analysis plan will be developed for the study protocol. The intervention effect over the 12-month period on the primary outcome (pain severity) and other outcomes will be estimated using linear mixed models. The models will include study arm, time (T1, T2, T3, T4) and time by study arm interaction as fixed effects and patient as random effect. Reasons for non-completion will be collected for participants withdrawing from the study. Multiple imputation will be used to handle missing data. Given the untestable assumption of data missing at random from those who do not provide information about reason for drop out, sensitivity analyses involving pattern mixture models will also be conducted to evaluate robustness of findings to different assumptions about participant dropout. The data analyst will be blinded to the group allocation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313273 0
Government body
Name [1] 313273 0
National Health and Medical Research Council
Country [1] 313273 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Geelong Waurn Ponds Campus
Locked Bag 20000
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 315041 0
None
Name [1] 315041 0
Address [1] 315041 0
Country [1] 315041 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312504 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312504 0
Human Research Ethics Office
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
Ethics committee country [1] 312504 0
Australia
Date submitted for ethics approval [1] 312504 0
31/03/2023
Approval date [1] 312504 0
Ethics approval number [1] 312504 0

Summary
Brief summary
Chronic pelvic pain syndrome (CPPS) subsumes several costly, common and challenging conditions including endometriosis and irritable bowel syndrome (IBS). Effective treatment is lacking, and CPPS is associated with poor quality of life (QoL), and psychological and sexual ill health. Hypnotherapy is an effective psychological treatment for mental health and pain. Hypnotherapy modulates neural processes associated with pain intensity and unpleasantness, supporting its use for CPPS where pain and distress become entrenched. Using a pragmatic, parallel-group, single-blind efficacy and implementation RCT, we aim to improve pain, mental health and reduce healthcare costs associated with CPPS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124898 0
Prof Antonina Mikocka-Walus
Address 124898 0
Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
Country 124898 0
Australia
Phone 124898 0
+61392468575
Fax 124898 0
Email 124898 0
mikocka@deakin.edu.au
Contact person for public queries
Name 124899 0
Ms Elesha Parigi
Address 124899 0
Deakin University
1 Gheringhap Street, Geelong, VIC. 3220
Country 124899 0
Australia
Phone 124899 0
+61 3 522 73612
Fax 124899 0
Email 124899 0
reststudy@deakin.edu.au
Contact person for scientific queries
Name 124900 0
Prof Antonina Mikocka-Walus
Address 124900 0
Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
Country 124900 0
Australia
Phone 124900 0
+61392468575
Fax 124900 0
Email 124900 0
mikocka@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will only be sharing unidentified agregated data to protect privacy of our participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.