TY - JOUR
T1 - Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care
T2 - study protocol for a randomised controlled trial
AU - Ganzevoort, Ilse Nadine
AU - Fokkema, Tryntsje
AU - Mol-Alma, Harma J.
AU - Heida, Anke
AU - van der Veen, Adriëlla L.
AU - Vermeulen, Karin
AU - Benninga, Marc A.
AU - Vlieger, Arine M.
AU - Berger, Marjolein Y.
AU - Holtman, G. A.
N1 - Funding Information: This work is supported by the Netherlands Organisation for Health Research and Development, ZonMw (grant number 852002035). Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/5/8
Y1 - 2023/5/8
N2 - 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.
AB - 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.
KW - Functional bowel disorders
KW - PRIMARY CARE
KW - Paediatric gastroenterology
UR - http://www.scopus.com/inward/record.url?scp=85158086025&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-069653
DO - https://doi.org/10.1136/bmjopen-2022-069653
M3 - Article
C2 - 37156587
SN - 2044-6055
VL - 13
SP - e069653
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e069653
ER -