Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial

• Published in: BMJ open Vol. 13; no. 5; p. e069653
• Main Authors: Ganzevoort, Ilse Nadine, Fokkema, Tryntsje, Mol-Alma, Harma J, Heida, Anke, Van der Veen, Adriëlla L, Vermeulen, Karin, Benninga, Marc A, Vlieger, Arine M, Berger, Marjolein Y, Holtman, G A
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 08.05.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Abdomen; Abdominal Pain - therapy; Child; Children & youth; Consent; Functional bowel disorders; General practice / Family practice; Humans; Hypnosis - methods; Hypnotherapy; Intervention; Irritable bowel syndrome; Irritable Bowel Syndrome - drug therapy; Medical referrals; Paediatric gastroenterology; Pain; Pediatrics; PRIMARY CARE; Primary Health Care; Questionnaires; Randomized Controlled Trials as Topic; Self Care - methods; Treatment Outcome; Netherlands; Paediatric gastroenterology; Functional bowel disorders; PRIMARY CARE
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-069653

IntroductionChildren often present to primary care with functional abdominal pain (FAP) or irritable bowel syndrome (IBS), and around half still have abdominal complaints 1 year later. Hypnotherapy is an evidence-based treatment that is used in specialist care, but it lacks evidence in primary care. This study will investigate the (cost) effectiveness of home-based guided hypnotherapy for children with FAP or IBS in primary care.Methods and analysisWe report the design of a pragmatic randomised controlled trial among children aged 7–17 years, diagnosed with FAP or IBS by their general practitioner (GP), with assessments over 12 months. The control group will receive care as usual (CAU) by their GP (eg, communication, education and reassurance), while the intervention group will receive CAU plus 3 months of home-based guided hypnotherapy via a website. The primary outcome will be the proportion of children with adequate relief from abdominal pain/discomfort at 12 months, analysed on an intention-to-treat basis. Secondary outcomes will include the adequacy of pain relief at 3 and 6 months, pain/discomfort severity, pain frequency and intensity, daily functioning and impact on function, anxiety and depression, pain beliefs, sleep disturbances, school absence, somatisation, and healthcare use and costs. We must include 200 children to determine a 20% difference in those with adequate relief (55% control vs 75% intervention).Ethics and disseminationThe Medical Ethics Review Committee of the University Medical Center Groningen, the Netherlands, approved this study (METc2020/237). The results will be disseminated to patients, GPs and other stakeholders via email, a dedicated website, peer-reviewed publications and presentations at national and international conferences. We plan to collaborate with the Dutch Society of GPs to implement the results in clinical practice.Trial registration numberNCT05636358.