DOI: 10.34760/6836d2cdaa04e
title: ZelfHy

description: 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. The objective is 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. The design is a randomized controlled trial with a total follow-up of 12 months. We include children from 7 to 18 years, with FAP or IBS according to their GP presenting in primary care in the Netherlands. The intervention consists of home-based hypnotherapy through self-exercises 5 times a week for approximately 15-20 minutes a day during 3 months in addition to UC 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. 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.
description: General Design

Type: Clinical trial
Data collection type: Prospective
Design: Longitudinal
Design description:
This study is a pragmatic randomized controlled trial (RCT) with a total follow-up of 12 months executed in primary care in the Netherlands. Participating children will be randomized 1:1 on the patient level to either the intervention or the care as usual group. The intervention group will receive 3 months home-based hypnotherapy by self-exercises in addition to care as usual by their GPs. The control group will receive usual care (UC) by their GPs alone according to the Dutch Society of GPs’ (NHG) guidelines. Outcomes are measured at baseline, three, six and 12 months follow-up.

Start/End data collection: 2020 until 2024
Design paper:
Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
External identifiers: Clinical Trials.gov: NCT05636358, METc number: 2020/237

Population

Countries: Netherlands (the)
Regions: Limburg, Zeeland, Zuid-Holland, Noord-Holland, Noord-Brabant, Flevoland, Utrecht, Gelderland, Overijssel, Drenthe, Friesland, Groningen
Number of participants: 152
Population age groups: Child (2-12 years), Adolescent (13-17 years)
Main medical condition: XI Diseases of the digestive system
Other inclusion criteria: 
Age 7-17 years. GP visit concerning chronic gastrointestinal symptoms. FAP or IBS according to their GP
Other exclusion criteria: 
A concomitant organic gastrointestinal disease. Treatment by a pediatrician for abdominal symptoms. Mental retardation. History of a psychotic disorder. Hypnotherapy treatment in the past year. Insufficient knowledge of the Dutch language by the child or parents.