Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial

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 car...

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Autores principales: Ganzevoort, Ilse Nadine, Fokkema, Tryntsje, Mol-Alma, Harma J, Heida, Anke, Van der Veen, Adriëlla L, Vermeulen, Karin, Benninga, Marc A, Vlieger, Arine M, Berger, Marjolein Y, Holtman, G A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10173965/
https://www.ncbi.nlm.nih.gov/pubmed/37156587
http://dx.doi.org/10.1136/bmjopen-2022-069653
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author Ganzevoort, Ilse Nadine
Fokkema, Tryntsje
Mol-Alma, Harma J
Heida, Anke
Van der Veen, Adriëlla L
Vermeulen, Karin
Benninga, Marc A
Vlieger, Arine M
Berger, Marjolein Y
Holtman, G A
author_facet Ganzevoort, Ilse Nadine
Fokkema, Tryntsje
Mol-Alma, Harma J
Heida, Anke
Van der Veen, Adriëlla L
Vermeulen, Karin
Benninga, Marc A
Vlieger, Arine M
Berger, Marjolein Y
Holtman, G A
author_sort Ganzevoort, Ilse Nadine
collection PubMed
description 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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spelling pubmed-101739652023-05-12 Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial Ganzevoort, Ilse Nadine Fokkema, Tryntsje Mol-Alma, Harma J Heida, Anke Van der Veen, Adriëlla L Vermeulen, Karin Benninga, Marc A Vlieger, Arine M Berger, Marjolein Y Holtman, G A BMJ Open General practice / Family practice 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. BMJ Publishing Group 2023-05-08 /pmc/articles/PMC10173965/ /pubmed/37156587 http://dx.doi.org/10.1136/bmjopen-2022-069653 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle General practice / Family practice
Ganzevoort, Ilse Nadine
Fokkema, Tryntsje
Mol-Alma, Harma J
Heida, Anke
Van der Veen, Adriëlla L
Vermeulen, Karin
Benninga, Marc A
Vlieger, Arine M
Berger, Marjolein Y
Holtman, G A
Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title_full Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title_fullStr Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title_full_unstemmed Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title_short Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
title_sort home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial
topic General practice / Family practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10173965/
https://www.ncbi.nlm.nih.gov/pubmed/37156587
http://dx.doi.org/10.1136/bmjopen-2022-069653
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