RecruitingACTRN12623000368639

Randomized e-Hypnotherapy for Chronic Pelvic Pain Study (REST)

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


Sponsor

Deakin University

Enrollment

132 participants

Start Date

Nov 18, 2024

Study Type

Interventional

Conditions

Summary

Chronic pelvic pain (CPP) is a condition that significantly impacts the quality of life (QoL) of effected people, with substantial associated costs to both the individual and healthcare system. 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 CPP where pain and distress become entrenched. A parallel-group, investigator-blinded, randomized control trial will aim to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, QoL, biopsychosocial outcomes, and cost-effectiveness. The e-hypnotherapy program will be reviewed by a group of eligible healthcare providers who will consider potential barriers/facilitators to ‘real world’ implementation. Review of the program by elegible healthcare providers will happen after the trial has been finalised. This review is relevant to the implementation rather than the participants.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic pelvic pain (CPP) is a persistent pain condition lasting more than three months that affects the lower abdomen or pelvis, and it significantly impacts quality of life, relationships, and mental wellbeing. It can have many causes — including endometriosis, bladder conditions, or nerve sensitivity — and is often difficult to treat. Hypnotherapy is a psychological treatment that works by using a deeply relaxed, focused state to change how the brain processes pain signals. Research in gut and pelvic pain has shown it can be effective, but access to qualified hypnotherapists is limited. This trial is delivering e-hypnotherapy — an online, self-guided hypnotherapy program — and comparing it against a relaxation program and a waitlist control to determine whether it reduces pain, improves quality of life, and is cost-effective. Participants are followed up to 12 months after the program. You may be eligible if you are 18 or older, live in Australia, have experienced pelvic pain for at least 3 months, have at least mild psychological distress, are not pregnant, and can read and understand English. People who have recently had pelvic surgery, had hypnotherapy recently, or have severe mental illness (including psychosis, PTSD, or bipolar disorder) would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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