None listed
Conditions
Brief 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.
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 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 sess
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Trial participants: At least 132 Australian adults living with CPP will be assigned across the 3 trial groups ( at least 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 7 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.
Exclusion criteria
Trial participants: Exclusion criteria will include: 1) Absence of pain as indicated by a score below 3 on the pain Numerical Rating Scale (NRS). 2) Recent pelvic area surgery (within the past 3 months). 3) Recent engagement in hypnotherapy (within the past 6 months). 4) Dissociative experiences as indicated by a score of 2.5 or above on the Brief Dissociative Experiences Scale (DES-B). 5) High risk of harming self/suicide (psychological screening by qualified practitioner). 6) Significant cognitive impairment (psychological screening by qualified practitioner). 7) Severe mental illness and/or symptoms (bipolar I or II, schizophrenia, psychosis, post-traumatic stress disorder, borderline personality disorder; psychological screening by qualified practitioner). 8) Substance use / dependence (psychological screening by qualified practitioner). 9) Concurrent participation in other clinical trials. Healthcare providers: There will be no exclusion criteria.
Outcome results
None listed