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 care...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e069653.full |
| _version_ | 1797831116307038208 |
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| author | Marc A Benninga Arine M Vlieger Anke Heida Tryntsje Fokkema Marjolein Y Berger Karin Vermeulen Ilse Nadine Ganzevoort Harma J Mol-Alma Adriëlla L Van der Veen G A Holtman |
| author_facet | Marc A Benninga Arine M Vlieger Anke Heida Tryntsje Fokkema Marjolein Y Berger Karin Vermeulen Ilse Nadine Ganzevoort Harma J Mol-Alma Adriëlla L Van der Veen G A Holtman |
| author_sort | Marc A Benninga |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-09T13:46:53Z |
| format | Article |
| id | doaj.art-59111aaea128408d9c518783e989ef13 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T13:46:53Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-59111aaea128408d9c518783e989ef132023-05-09T02:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-069653Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trialMarc A Benninga0Arine M Vlieger1Anke Heida2Tryntsje Fokkema3Marjolein Y Berger4Karin Vermeulen5Ilse Nadine Ganzevoort6Harma J Mol-Alma7Adriëlla L Van der Veen8G A Holtman9Department of Paediatric Gastroenterology, Emma Childrens` Hospital UMC, Amsterdam, The NetherlandsPaediatrics, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands1 Department of Paediatric Gastroenterology, University Medical Center Groningen, Groningen, The Netherlands1 Department of General Practice, Erasmus MC University Medical Center, Rotterdam, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsEpidemiology, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The NetherlandsDepartment of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/13/5/e069653.full |
| spellingShingle | Marc A Benninga Arine M Vlieger Anke Heida Tryntsje Fokkema Marjolein Y Berger Karin Vermeulen Ilse Nadine Ganzevoort Harma J Mol-Alma Adriëlla L Van der Veen G A Holtman 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 |
| 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 |
| url | https://bmjopen.bmj.com/content/13/5/e069653.full |
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