MedTrace Logo

Hypnotherapy Through Self-exercises in Children With Functional Abdominal Pain in Primary Care

NCT05636358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-01-01

No results posted yet for this study

Summary

The goal of this randomised controlled trial is to study the (cost-)effectiveness of home-based hypnotherapy by self-exercises in children with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) in primary care. The main questions it aims to answer are:

* What is the effect of home-based hypnotherapy by self-exercises on adequate relief of abdominal pain and discomfort in addition to care as usual of general practitioners (GPs), compared to care as usual of GPs alone in children with FAP or IBS?
* What is the effect of home-based hypnotherapy by self-exercises in addition to care as usual by GPs compared to care as usual of GPs alone in children with FAP or IBS on:

* Frequency and intensity of abdominal pain and discomfort
* Pain severity
* Daily functioning and impact
* Anxiety and depression
* Pain beliefs
* Sleep disturbances
* School absence
* Use of health care services, including GP visits and referrals to secondary care
* Costs (healthcare and societal perspective)

Participants in the intervention group will receive home-based hypnotherapy 5 times a week for approximately 15-20 minutes a day during 3 months in addition to care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain.

Participants in the control group will receive care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain.

Conditions

  • Functional Gastrointestinal Disorders
  • Irritable Bowel Syndrome
  • Functional Abdominal Pain Syndrome

Interventions

OTHER

Home-based hypnotherapy

The home-based hypnotherapy package contains five standard hypnosis exercises. They consist of one breathing exercise, and four visualisation exercises. Two separate sets adjusted to the child's age will be used: one for children younger than 12 years and one for children of 12 years and older. The children will be asked to listen to the exercises at least 5 times per week, for approximately 15-20 minutes per day, during a period of 3 months. A workbook will provide children and/or parents with the instructions and planning of the exercises.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Marjolein Y. Berger, prof · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636358 on ClinicalTrials.gov