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

NCT05636358 | Completed DMC

• 3 other identifiers: NL73562.042.20NL8500852002035
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary care; Children and adolescents

Outcome Measures

Primary Outcomes (1)

• Adequate relief at 12 months

  Proportion of children with adequate relief of abdominal pain at 12 months follow-up Child and/or parents are asked whether the child has adequate relief of FAP or IBS related abdominal pain during the past week using a dichotomous scale (yes/no). This question is a well validated outcome measurement in trials on treatment for IBS.

  12 months

Secondary Outcomes (11)

• Adequate relief at 3 and 6 months

  3 and 6 months

• Pain frequency and intensity

  0, 3, 6, and 12 months

• Severity of pain

  0, 3, 6, and 12 months

• Daily functioning and impact

  0, 3, 6, and 12 months

• Anxiety and depression

  0, 3, 6, and 12 months

Other Outcomes (6)

• Patient baseline characteristics

  Baseline

• Paediatric gastrointestinal symptoms

  Baseline

• Usage of hypnotherapy self-exercises

  3 months

Study Arms (2)

Home-based hypnotherapy

EXPERIMENTAL

The intervention includes existing home-based hypnotherapy self-exercises in MP3 format for a period of three months. The intervention group of children with FAP or IBS in primary care receives the home-based hypnotherapy self exercises in addition to care as usual by their GP according to the guideline commissioned by the Dutch Society of GPs.

Other: Home-based hypnotherapy

Control

NO INTERVENTION

The control group of children with FAP or IBS in primary care will receive only care as usual by their GP. After the end of the study, the control group will also receive access to the home-based hypnotherapy exercises, if desired.

Interventions

Home-based hypnotherapy OTHER

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.

Home-based hypnotherapy

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 7 to 17 years
• GP visit concerning chronic gastrointestinal symptoms
• FAP or IBS according to their GP

You may not qualify if:

• A concomitant organic gastrointestinal disease
• Treatment by a paediatrician for abdominal symptoms
• Intellectual disability
• A history of a psychotic disorder
• Hypnotherapy treatment in the past year
• Insufficient knowledge of the Dutch language by the child or parents

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (18)

• Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.

  PMID: 27144632 BACKGROUND

• Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1;171(5):470-477. doi: 10.1001/jamapediatrics.2017.0091.

  PMID: 28346581 BACKGROUND

• Lisman-van Leeuwen Y, Spee LA, Benninga MA, Bierma-Zeinstra SM, Berger MY. Prognosis of abdominal pain in children in primary care--a prospective cohort study. Ann Fam Med. 2013 May-Jun;11(3):238-44. doi: 10.1370/afm.1490.

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• Gieteling M, Van Dijk P, De Jonge A, Albeda F, Berger M, Burgers J. NHG-Standaard Buikpijn bij kinderen. Huisarts Wet 2012; 55: 404-409.

  BACKGROUND

• Mangel AW, Hahn BA, Heath AT, Northcutt AR, Kong S, Dukes GE, McSorley D. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res. 1998 Mar-Apr;26(2):76-81. doi: 10.1177/030006059802600203.

  PMID: 9602985 BACKGROUND

• Saps M, van Tilburg MA, Lavigne JV, Miranda A, Benninga MA, Taminiau JA, Di Lorenzo C. Recommendations for pharmacological clinical trials in children with irritable bowel syndrome: the Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2016 Nov;28(11):1619-1631. doi: 10.1111/nmo.12896. Epub 2016 Jul 31.

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• Castarlenas E, Jensen MP, von Baeyer CL, Miro J. Psychometric Properties of the Numerical Rating Scale to Assess Self-Reported Pain Intensity in Children and Adolescents: A Systematic Review. Clin J Pain. 2017 Apr;33(4):376-383. doi: 10.1097/AJP.0000000000000406.

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  PMID: 19807604 BACKGROUND

• Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.

  PMID: 22329531 BACKGROUND

• Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.

  PMID: 27363626 BACKGROUND

• Steur LMH, Grootenhuis MA, Terwee CB, Pillen S, Wolters NGJ, Kaspers GJL, van Litsenburg RRL. Psychometric properties and norm scores of the sleep self report in Dutch children. Health Qual Life Outcomes. 2019 Jan 16;17(1):15. doi: 10.1186/s12955-018-1073-x.

  PMID: 30651118 BACKGROUND

• iMTA Productivity Cost Questionnaire and iMTA Medical Consumption Questionnaire. Retrieved at the 9th of April 2020 from https://www.imta.nl/questionnaires/.

  BACKGROUND

• Wille N, Badia X, Bonsel G, Burstrom K, Cavrini G, Devlin N, Egmar AC, Greiner W, Gusi N, Herdman M, Jelsma J, Kind P, Scalone L, Ravens-Sieberer U. Development of the EQ-5D-Y: a child-friendly version of the EQ-5D. Qual Life Res. 2010 Aug;19(6):875-86. doi: 10.1007/s11136-010-9648-y. Epub 2010 Apr 20.

  PMID: 20405245 BACKGROUND

• Ravens-Sieberer U, Wille N, Badia X, Bonsel G, Burstrom K, Cavrini G, Devlin N, Egmar AC, Gusi N, Herdman M, Jelsma J, Kind P, Olivares PR, Scalone L, Greiner W. Feasibility, reliability, and validity of the EQ-5D-Y: results from a multinational study. Qual Life Res. 2010 Aug;19(6):887-97. doi: 10.1007/s11136-010-9649-x. Epub 2010 Apr 17.

  PMID: 20401552 BACKGROUND

• Rutten JM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon a Ten W, Van Wering H, Dijkgraaf MG, Merkus MP, Benninga MA. Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists. BMC Pediatr. 2014 Jun 4;14:140. doi: 10.1186/1471-2431-14-140.

  PMID: 24894077 BACKGROUND

• Meesters C, Muris P, Ghys A, Reumerman T, Rooijmans M. The Children's Somatization Inventory: further evidence for its reliability and validity in a pediatric and a community sample of Dutch children and adolescents. J Pediatr Psychol. 2003 Sep;28(6):413-22. doi: 10.1093/jpepsy/jsg031.

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• Ganzevoort IN, Berger MY, Vlieger AM, Benninga MA, De Boer MR, Holtman GA. Children with disorders of gut-brain interaction in primary care versus hospital care: A comparison of characteristics. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):530-539. doi: 10.1002/jpn3.70129. Epub 2025 Jun 29.

  PMID: 40581866 DERIVED

• Ganzevoort IN, Fokkema T, Mol-Alma HJ, Heida A, Van der Veen AL, Vermeulen K, Benninga MA, Vlieger AM, Berger MY, Holtman GA. Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial. BMJ Open. 2023 May 8;13(5):e069653. doi: 10.1136/bmjopen-2022-069653.

  PMID: 37156587 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Study Officials

• Marjolein Y. Berger, prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although the children and GP's cannot be blinded to the allocation, researchers performing the analyses will be blinded for allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a pragmatic randomised controlled trial (RCT) with a total follow-up of 12 months executed in primary care in the Netherlands. Participating children will be randomised 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 according to the Dutch Society of GPs' (NHG) guideline. The control group will receive usual care (UC) by their GPs alone according to the Dutch Society of GPs' (NHG) guideline.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 5, 2022
• Study Start: March 5, 2021
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After all publications concerning the study are published.
• Access Criteria: Data will be made available upon reasonable request.

Locations

NL (1)