Rationale: Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are the two major functional abdominal pain disorders in children in which symptoms cannot be explained by an organic condition. These functional disorders are associated with a substantial reduced quality of life, school absence, sleep disturbances, and anxiety and depression. Most children with FAP or IBS are managed in primary care. Management of FAP or IBS in primary care is challenging, however in specialist care hypnotherapy by self-exercises is an evidence-based treatment. Evidence from applying these hypnotherapy self-exercises in primary care is absent, but this approach may be effective, reduce costs and minimize time investments for children, parents, physicians and therapists.
Objective: To determine the (cost)-effectiveness of home-based hypnotherapy by self-exercises added to usual care (UC) of general practitioners (GPs) compared with UC of GPs alone in children with FAP or IBS.
Study design: Randomised controlled trial with a total follow-up of 12 months.
Study population: Children, 7 to 18 years, with FAP or IBS according to the ROME IV criteria presenting in primary care in the Netherlands.
Intervention: Home-based hypnotherapy through self-exercises 5 times a week for approximately 15-20 minutes a day during 3 months in addition to care as usual by the GP. This will be compared with a control group receiving UC, which is defined as care according to the Dutch Society of GPs’ (NHG) guideline for abdominal pain in children.
Main study parameters/endpoints: Primary outcome is the proportion of children with adequate relief of abdominal pain and discomfort at 12 months. Secondary outcomes are frequency and intensity of abdominal pain/discomfort, school absence, impact on daily functioning, depression and anxiety, pain beliefs, sleep disturbances, use of healthcare services and cost-effectiveness at 3, 6, and 12 months.