Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000368639
Ethics application status
Approved
Date submitted
27/03/2023
Date registered
13/04/2023
Date last updated
29/08/2024
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 Study (REST)
Scientific title
A parallel group, investigator-blinded, randomized control trial comparing the effect of e-hypnotherapy vs. relaxation and waitlist on pain, cost effectiveness and biopsychosocial outcomes in people with chronic pelvic pain
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
People diagnosed with chronic pelvic pain (CPP) will be randomly allocated (1:1:1) to an e-hypnotherapy (intervention), relaxation (control group 1/active control) or waitlist (control group 2) group for 7 weeks. The entirety of the study will be conducted virtually. The trial will be delivered via a dedicated website (Platform O).

e-Hypnotherapy - intervention: Participants randomized to e-hypnotherapy will have access to a 7-week online intervention which will include one pain education session and seven self-directed e-hypnotherapy modules. The e-hypnotherapy program will include stages of hypnotic induction, deepening, suggestion, and reorientation techniques. Participants will be able to ‘choose their own adventure’ and be provided with a range of hypnotic induction, deepening, suggestion, and reorientation techniques, including direct and indirect styles, visual and non-visual options, and mindfulness-based elements. They will also be able to preference listening to a male or female voice.

Relaxation - control group 1/active control: Participants randomized to relaxation will have access to a 7-week online intervention which includes one pain education session and seven self-directed relaxation modules, specifically designed to address a wide number of CPP elements. The relaxation intervention has been designed as an active control to allow masking with the format, delivery, and follow-up aiming to mimic the intervention group.

The relaxation program will include stages of non-hypnotic induction, relaxation, and reorientation techniques. Like in the hypnosis program, participants will be able to ‘choose their own adventure’ by selecting their choice of non-hypnotic induction and reorientation audio recordings, as well as preference listening to a male or female voice. The relaxation materials will be designed symmetrically to the intervention, meaning they address the same overarching and specific themes and use the same tools and techniques where non-hypnotic versions are possible. Participation and adherence requirements and strategies to maximize adherence will mirror those in the intervention.

Participants will be asked to complete one module (approximately 40 minutes) per week for 7 weeks; however, they will have access to all modules throughout the 7 weeks. Adherence to the e-hypnotherapy program will be monitored weekly with participation in 80% of the program’s content to be considered adequate adherence. Treatment fidelity problems are not anticipated as the interventions will be pre-recorded. Participants will be contacted to provide feedback if they do not engage or if they choose to withdraw from the study.

Module 1 (pain education) will be delivered via a short video. Modules 2-8 will be delivered via audio recording.
Intervention code [1] 325520 0
Behaviour
Intervention code [2] 325521 0
Lifestyle
Intervention code [3] 325522 0
Treatment: Other
Comparator / control treatment
Waitlist - control group 2: Participants randomized to the waitlist control will be assigned to a waiting list and will be offered the e-hypnotherapy intervention following the collection of their 12-month follow-up data.
Control group
Active

Outcomes
Primary outcome [1] 333986 0
Pain and functioning will be measured using the Brief Pain Inventory (BPI)
Timepoint [1] 333986 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up). Main outcome is at 7 weeks post-intervention.
Primary outcome [2] 339244 0
Pain and the level to which participants are bothered by pain will be measured using Numerical Rating Scales (NRS)
Timepoint [2] 339244 0
Primary outcome [3] 339245 0
Pain and the level to which participants are bothered by pain will be measured using Numerical Rating Scales (NRS)
Timepoint [3] 339245 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up). Main outcome is at 7 weeks post-intervention. Main outcome is at 7 weeks post-intervention.
Primary outcome [4] 339246 0
Pain and the level to which participants are bothered by pain will be measured using qualitative questions.
Timepoint [4] 339246 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up). Main outcome is at 7 weeks post-intervention. Main outcome is at 7 weeks post-intervention.
Primary outcome [5] 339247 0
Pain and the level to which participants are bothered by pain will be measured using qualitative questions.
Timepoint [5] 339247 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up). Main outcome is at 7 weeks 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
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [2] 418950 0
Quality of Life (QOL) will be measured with the EQ5D5L
Timepoint [2] 418950 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [3] 418951 0
Psychological symptoms will be measured by the Depression Anxiety Stress Scale (DASS-21)
Timepoint [3] 418951 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [4] 418952 0
Fatigue will be measured by the Fatigue Symptom Inventory (FSI)
Timepoint [4] 418952 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [5] 418953 0
Sleep quality will be measured with the Jenkins Sleep Scale
Timepoint [5] 418953 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [6] 420399 0
Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS)
Timepoint [6] 420399 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [7] 420400 0
Self-efficacy will be measured with the Pain Self-Efficacy Questionnaire (PSEQ).
Timepoint [7] 420400 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
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
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [9] 420402 0
Participant engagement treatment satisfaction will be assessed via NRS' and qualitative questions.
Timepoint [9] 420402 0
Weekly throughout 7-week intervention
Secondary outcome [10] 420403 0
Adverse events will be monitored across intervention groups throughout the trial. Safety data will be collected via email, Qualtrics, or over the phone by a member of the study team. In addition to weekly check-in emails, participants will receive a check-in phone call by a member of the study team during weeks three and seven of the intervention. Any adverse events reported will be followed up by a member of the study team with relevant qualifications, e.g., psychologist.
Timepoint [10] 420403 0
Check-in emails: weekly throughout 7-week intervention.
Check-in phone calls: weeks 3 and 7 post-intervention commencement.
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
Secondary outcome [12] 439215 0
Somatic symptoms will be measured using the Somatic Symptoms Scale (SSS)
Timepoint [12] 439215 0
Secondary outcome [13] 439216 0
Somatic symptoms will be measured using the Somatic Symptoms Scale (SSS)
Timepoint [13] 439216 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [14] 439217 0
Central sensitization will be measured using the Fibromyalgia Criteria-2016
Timepoint [14] 439217 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [15] 439218 0
Central sensitization will be measured using the Fibromyalgia Criteria-2016
Timepoint [15] 439218 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [16] 439219 0
Treatment satisfaction will be assessed via NRS' and qualitative questions.
Timepoint [16] 439219 0
Baseline (pre-intervention), 7 weeks (post-intervention), 6 and 12 months following the intervention (follow-up).
Secondary outcome [17] 439220 0
Treatment satisfaction will be assessed via NRS' and qualitative questions.
Timepoint [17] 439220 0
Weekly throughout 7-week intervention
Secondary outcome [18] 439221 0
A cost-utility analysis (cost per additional Quality Adjusted Life Year (QALY)) will also be conducted at 12 months.
Intervention, healthcare, productivity, and out-of-pocket costs will be estimated from the Resource Use Questionnaire, employment questionnaire and Services Australia data. Standardized economic evaluation techniques including incremental analysis of mean differences, generalized linear modelling techniques and bootstrapping to determine confidence intervals will be used. If the intervention is found to be effective, budgetary impact of routine roll-out will also be estimated.
Timepoint [18] 439221 0
Weekly throughout 7-week intervention
Secondary outcome [19] 439222 0
A cost-utility analysis (cost per additional Quality Adjusted Life Year (QALY)) will also be conducted at 12 months.
Intervention, healthcare, productivity, and out-of-pocket costs will be estimated from the Resource Use Questionnaire, employment questionnaire and Services Australia data. Standardized economic evaluation techniques including incremental analysis of mean differences, generalized linear modelling techniques and bootstrapping to determine confidence intervals will be used. If the intervention is found to be effective, budgetary impact of routine roll-out will also be estimated.
Timepoint [19] 439222 0
12 months post intervention commencement.

Eligibility
Key inclusion criteria
Trial participants:

Up to 132 Australian adults living with CPP will be assigned across the 3 trial groups (44 in each group). Inclusion criteria will include:

1) Self-reported chronic pelvic pain, with pain persisting for at least 3-months.
2) At least mild psychological distress (score of 16 or above on the Kessler Psychological Distress Scale (K10)).
3) At least 18 years of age.
4) Capacity to provide informed consent.
5) Currently residing in Australia.
6) Not pregnant nor seeking to become pregnant in the next 8 weeks.
7) English speaking, or sufficient level of English to understand the trial intervention, answer relevant questionnaires and participate in online intervention.

Healthcare providers:

The e-hypnotherapy program will be reviewed by a group of eligible healthcare providers who will consider potential barriers/facilitators to ‘real world’ implementation

Inclusion criteria will include:

• Be a CPP-related healthcare provider (e.g., doctor, nurse, specialist, psychologist, dietician, etc.).
• Reside in Australia.
• Be at least 18 years of age.
• Be proficient in English.

Qualitative interview participants:

Up to 60 trial participants who have completed the REST program (30 hypnotherapy participants and 30 relaxation participants) will complete interviews at T2 (7 weeks), T3 (6 months) and T4 (12 months) post-intervention. Up to 15 CPP-related healthcare providers will also be interviewed at T4.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trial participants:

Exclusion criteria will include:

1) Absence of pain (score below 3 on the pain Numerical Rating Scale (NRS)).
2) Currently pregnant.
3) Recent pelvic area surgery (within the past 6 months).
4) Recent engagement in hypnotherapy (within the past 6 months).
5) Dissociative experiences (score of 2.5 or above on the Brief Dissociative Experiences Scale (DES-B)).
6) High risk of harming self/suicide (psychological screening by the psychology team).
7) Significant cognitive impairment (psychological screening by the psychology team).
8) Severe mental illness and/or symptoms (bipolar I or II, schizophrenia, psychosis, post-traumatic stress disorder, borderline personality disorder; psychological screening by the psychology team).
9) Substance use /substance dependence (psychological screening by psychology team).

Healthcare providers:

There will be no exclusion criteria.

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 randomization 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 receiving the treatment/s

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
Sample size:

The sample size was calculated for pain severity measured on the NRS (0-10) using the software GLIMMPSE. We assumed a baseline mean of 6 and a standard deviation (SD) of 2.2 in all groups. At 8 weeks (posttreatment), we assumed a mean of 5.5 in the waitlist group, 5 in the relaxation group and 4.3 in e-hypnotherapy (a clinically meaningful reduction in mean pain score on the NRS is 1.7447). Assuming a correlation between baseline and post-treatment of 0.75 and using the linear mixed effects models, a sample of 102 achieves 80% power (a=0.05; two-sided tests). Assuming 30% attrition, consistent with our pilot findings, we will recruit 132 participants across the three groups (44 in each group).

Data Analysis

Descriptive statistics will be provided for baseline demographic and health-related data, satisfaction ratings, module completion rates, as well as participant recruitment and retention rates (and reasons for withdrawal).

Efficacy Analysis

All quantitative statistical analyses will be conducted on an Intention-To-Treat basis (ITT). The intervention effect over 12 months on the primary outcome (pain) and other biopsychosocial outcomes will be estimated using linear mixed models. The models will include group, time (T1, T2, T3, T4), time by group interaction as fixed effects, and participant as random effect.

Economic data evaluation will involve cost-consequences analysis from a societal perspective and will compare the incremental costs to the full spectrum of outcomes via a series of cost-effectiveness ratios, e.g., the incremental cost per additional responder for improvement in pain, psychological symptoms, and QoL. A cost-utility analysis (cost per additional Quality Adjusted Life Year (QALY)) will also be conducted at 12 months.
Intervention, healthcare, productivity, and out-of-pocket costs will be estimated from the Resource Use Questionnaire, employment questionnaire and Services Australia data. Standardized economic evaluation techniques including incremental analysis of mean differences, generalized linear modelling techniques and bootstrapping to determine confidence intervals will be used. If the intervention is found to be effective, budgetary impact of routine roll-out will also be estimated.

Qualitative data collected during semi-structured interviews with participants will be transcribed and analyzed thematically, following the main procedural steps of Template Thematic Analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
30/11/2026
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
Approved
Ethics committee name [1] 312504 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312504 0
Ethics committee country [1] 312504 0
Australia
Date submitted for ethics approval [1] 312504 0
31/03/2023
Approval date [1] 312504 0
23/05/2024
Ethics approval number [1] 312504 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124898 0
A/Prof Subhadra Evans
Address 124898 0
Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
Country 124898 0
Australia
Phone 124898 0
+61 392446270
Fax 124898 0
Email 124898 0
[email protected]
Contact person for public queries
Name 124899 0
A/Prof. Subhadra Evans
Address 124899 0
Deakin University
1 Gheringhap Street, Geelong, VIC. 3220
Country 124899 0
Australia
Phone 124899 0
+61 392446270
Fax 124899 0
Email 124899 0
[email protected]
Contact person for scientific queries
Name 124900 0
A/Prof Subhadra Evans
Address 124900 0
Deakin University
School of Psychology
221 Burwood Hwy
Burwood 3125 VIC
Country 124900 0
Australia
Phone 124900 0
+61 392446270
Fax 124900 0
Email 124900 0
[email protected]

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.