Randomized e-Hypnotherapy for Chronic Pelvic Pain Study (REST): Comparing e-Hypnotherapy to Relaxation and Waitlist to Improve Pain, Cost Effectiveness and Biopsychosocial Outcomes (Preprint)

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BACKGROUND Background: Chronic pelvic pain (CPP), defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. OBJECTIVE The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL, and biopsychosocial outcomes, and to evaluate cost-effectiveness. METHODS Methods: A parallel-group, investigator-blinded, randomized control trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalized e-hypnotherapy program (n = 44), a 7-week online personalized relaxation control (n = 44), or waitlist control (n = 44). The primary outcome will be self-reported pain level and secondary outcomes will include psychological distress, QoL, pain catastrophizing, self-efficacy, central sensitization, somatic symptoms, fatigue, and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n = 20) and relaxation (n = 20) groups, to understand barriers/facilitators for ongoing use. RESULTS Data analyses will include mixed-effects regression models, cost-utility analysis from a health system and societal perspective, and thematic analysis. The e-hypnotherapy program will also be reviewed by a group of eligible healthcare providers who will consider potential barriers/facilitators for ‘real world’ implementation. CONCLUSIONS n/a CLINICALTRIAL This protocol has received ethics approval in Australia from Deakin University Research Ethics Committee (DUREC Ref.2024-080). The trial was prospectively registered in the Australian New Zealand Clinical Trials Registry on 13th April 2023 (ID: ACTRN12623000368639).

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