PT  - JOURNAL ARTICLE
AU  - Pamela D Browne
AU  - Bibiche den Hollander
AU  - Esther M Speksnijder
AU  - Herbert M van Wering
AU  - Walther Tjon a Ten
AU  - Elvira K George
AU  - Michael Groeneweg
AU  - Nanja Bevers
AU  - Margaretha M S Wessels
AU  - Maartje M van den Berg
AU  - Joery Goede
AU  - Sarah T A Teklenburg-Roord
AU  - Carla Frankenhuis
AU  - Marc A Benninga
AU  - Arine M Vlieger
TI  - Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial
AID  - 10.1136/bmjopen-2018-024903
DP  - 2019 Jun 01
TA  - BMJ Open
PG  - e024903
VI  - 9
IP  - 4
4099  - http://bmjopen.bmj.com/content/9/4/e024903.short
4100  - http://bmjopen.bmj.com/content/9/4/e024903.full
SO  - BMJ Open2019 Jun 01; 9
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.