Evans, Subhadra (S);Naude, Colette (C);Coitinho Biurra, Yao (Y);Bowring, Jessica (J);Knowles, Simon (S);Brooks, Tiffany (T);Skvarc, David (D);Esterman, Adrian (A);Fuller-Tyszkiewicz, Matthew (M);Klas, Anna (A);Van Niekerk, Leesa (L);McCaffrey, Nikki (N);Stanley, Katherine (K);Druitt, Marilla (M);Andrews, Jane (J);Vancaillie, Thierry (T);Cheah, Suiyin (S);Ciccia, Donna (D);Blake, Lily (L);Bassili, Anna (A);Mikocka-Walus, Antonina (A);

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BMJ Open.2025 Nov 19;15(11):e102697.doi:10.1136/bmjopen-2025-102697

Abstract

BACKGROUND: Chronic pelvic pain, 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. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

METHODS: A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised 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 catastrophising, self-efficacy, central sensitisation, 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 meaningful change and barriers/facilitators for ongoing use.

ETHICS AND DISSEMINATION: This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind-body interventions.

TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.