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

Not Applicable

Not yet recruiting

• Conditions: Oral and Gastrointestinal - Crohn's disease; Renal and Urogenital - Pelvic inflammatory disease; Chronic pelvic pain; Reproductive Health and Childbirth - Menstruation and menopause; Oral and Gastrointestinal - Inflammatory bowel disease; Renal and Urogenital - Other renal and urogenital disorders; Anaesthesiology - Pain management

• Registration Number: ACTRN12623000368639
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 132

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.

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

• Study Type: Interventional
• Study Design: Not specified