Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial

Pamela D. Browne, Bibiche den Hollander, Esther M. Speksnijder, Herbert M. van Wering, Walther Tjon A ten, Elvira K. George, Michael Groeneweg, Nanja Bevers, Margaretha M. S. Wessels, Maartje M. van den Berg, Joery Goede, Sarah T. A. Teklenburg-Roord, Carla Frankenhuis, Marc A. Benninga, Arine M. Vlieger

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea. Methods and analysis To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8-18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months' follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months' follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea. Ethics and dissemination Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands. Trial registration number NTR5814.
LanguageEnglish
Article numbere024903
JournalBMJ Open
Volume9
Issue number4
DOIs
Publication statusPublished - 2019

Cite this

Browne, P. D., den Hollander, B., Speksnijder, E. M., van Wering, H. M., Tjon A ten, W., George, E. K., ... Vlieger, A. M. (2019). Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial. BMJ Open, 9(4), [e024903]. https://doi.org/10.1136/bmjopen-2018-024903
Browne, Pamela D. ; den Hollander, Bibiche ; Speksnijder, Esther M. ; van Wering, Herbert M. ; Tjon A ten, Walther ; George, Elvira K. ; Groeneweg, Michael ; Bevers, Nanja ; Wessels, Margaretha M. S. ; van den Berg, Maartje M. ; Goede, Joery ; Teklenburg-Roord, Sarah T. A. ; Frankenhuis, Carla ; Benninga, Marc A. ; Vlieger, Arine M. / Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial. In: BMJ Open. 2019 ; Vol. 9, No. 4.
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abstract = "Introduction The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea. Methods and analysis To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8-18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50{\%} reduction of nausea, compared with baseline at 12 months' follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months' follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea. Ethics and dissemination Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands. Trial registration number NTR5814.",
author = "Browne, {Pamela D.} and {den Hollander}, Bibiche and Speksnijder, {Esther M.} and {van Wering}, {Herbert M.} and {Tjon A ten}, Walther and George, {Elvira K.} and Michael Groeneweg and Nanja Bevers and Wessels, {Margaretha M. S.} and {van den Berg}, {Maartje M.} and Joery Goede and Teklenburg-Roord, {Sarah T. A.} and Carla Frankenhuis and Benninga, {Marc A.} and Vlieger, {Arine M.}",
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Browne, PD, den Hollander, B, Speksnijder, EM, van Wering, HM, Tjon A ten, W, George, EK, Groeneweg, M, Bevers, N, Wessels, MMS, van den Berg, MM, Goede, J, Teklenburg-Roord, STA, Frankenhuis, C, Benninga, MA & Vlieger, AM 2019, 'Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial', BMJ Open, vol. 9, no. 4, e024903. https://doi.org/10.1136/bmjopen-2018-024903

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial. / Browne, Pamela D.; den Hollander, Bibiche; Speksnijder, Esther M.; van Wering, Herbert M.; Tjon A ten, Walther; George, Elvira K.; Groeneweg, Michael; Bevers, Nanja; Wessels, Margaretha M. S.; van den Berg, Maartje M.; Goede, Joery; Teklenburg-Roord, Sarah T. A.; Frankenhuis, Carla; Benninga, Marc A.; Vlieger, Arine M.

In: BMJ Open, Vol. 9, No. 4, e024903, 2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: Protocol of a multicentre randomised trial

AU - Browne, Pamela D.

AU - den Hollander, Bibiche

AU - Speksnijder, Esther M.

AU - van Wering, Herbert M.

AU - Tjon A ten, Walther

AU - George, Elvira K.

AU - Groeneweg, Michael

AU - Bevers, Nanja

AU - Wessels, Margaretha M. S.

AU - van den Berg, Maartje M.

AU - Goede, Joery

AU - Teklenburg-Roord, Sarah T. A.

AU - Frankenhuis, Carla

AU - Benninga, Marc A.

AU - Vlieger, Arine M.

PY - 2019

Y1 - 2019

N2 - Introduction The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea. Methods and analysis To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8-18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months' follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months' follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea. Ethics and dissemination Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands. Trial registration number NTR5814.

AB - Introduction The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea. Methods and analysis To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8-18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months' follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months' follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea. Ethics and dissemination Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands. Trial registration number NTR5814.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30975672

U2 - 10.1136/bmjopen-2018-024903

DO - 10.1136/bmjopen-2018-024903

M3 - Article

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JO - BMJ Open

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