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Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary
Ilse Nadine Ganzevoort1, Tryntsje Fokkema1, Harma J Mol-Alma1
1Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands.
Insights
This study investigates home-based hypnotherapy for children with functional abdominal pain or irritable bowel syndrome in primary care. Results will show if hypnotherapy effectively reduces symptoms and improves quality of life.
Area of Science:
- Pediatric Gastroenterology
- Evidence-Based Medicine
- Digital Health Interventions
Background:
- Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are common in children presenting to primary care.
- A significant proportion of children experience persistent abdominal complaints one year later.
- Current evidence for hypnotherapy in FAP/IBS is primarily from specialist settings, with a gap in primary care research.
Purpose of the Study:
- To investigate the (cost) effectiveness of home-based guided hypnotherapy for children with FAP or IBS in a primary care setting.
- To evaluate the impact of this intervention on abdominal pain and related symptoms over 12 months.
- To provide evidence for the implementation of accessible hypnotherapy in general practice.
Main Methods:
- A pragmatic randomised controlled trial involving children aged 7-17 years diagnosed with FAP or IBS.
- The intervention group receives usual care plus 3 months of home-based guided hypnotherapy via a website.
- The control group receives usual care (communication, education, reassurance) from their general practitioner.
Main Results:
- The primary outcome is the proportion of children achieving adequate relief from abdominal pain/discomfort at 12 months.
- Secondary outcomes include pain severity, frequency, daily functioning, anxiety, depression, and healthcare utilization.
- The study is powered to detect a 20% difference in adequate relief between groups (75% intervention vs. 55% control).
Conclusions:
- This trial will provide crucial data on the effectiveness and cost-effectiveness of home-based hypnotherapy for pediatric FAP/IBS in primary care.
- Findings could support the integration of digital hypnotherapy into routine pediatric primary care.
- Successful implementation could improve long-term outcomes for children suffering from functional abdominal pain.
Introduction:
Children 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 Analysis:
We 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 Dissemination:
The 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 Number:
NCT05636358.
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