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

Abstract

IntroductionThe 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 analysisTo 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 disseminationResults 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 numberNTR5814.

Functional Gastrointestinal Disorders in Mediterranean Countries According to Rome IV Criteria

“…Although studies conducted in recent years have clarified some mechanisms underlying FD, including delayed gastric emptying, impaired gastric motility, and/or abnormal central nervous system processing of gastric stimuli through the gut–brain axis. Additionally, there are indications that psychological factors, including anxiety and stress (28), may increase the severity of nausea through the gut–brain axis and gut‐directed hypnotherapy (HT) has been shown to reduce symptoms of nausea in children and adolescents with FD (29).…”

Children with functional gastrointestinal disorders with and withoutco‐existingnausea: A comparison of clinical and psychological characteristics

“…The trial included 100 children (aged 8–18 years) fulfilling the Rome IV criteria for FN or FD and having nausea as their main complaint. Detailed descriptions of the study protocol and the results can be found elsewhere 15,19 . In both trials, all children underwent laboratory testing and stool analysis to exclude underlying (organic) diseases before inclusion.…”

“…Detailed descriptions of the study protocol and the results can be found elsewhere. 15,19 In both trials, all children underwent laboratory testing and stool analysis to exclude underlying (organic) diseases before inclusion. Exclusion criteria in both studies were insufficient knowledge of the Dutch language or intellectual disability.…”

Proceedings of the 2018 Advances In Motility and In NeuroGastroenterology

“…In adults, cognitive behavioral therapy and gut-directed hypnosis are strategies to build insight and enhance cognitive and behavioral response to symptoms (18), whereas neuromodulator medications alter visceral hypersensitivity (17). Thus far, in pediatric population, there is lack of evidence-based pharmacologic agents that are recommended for the treatment of nonerosive esophageal disorders though promising studies on the utility of gut directed hypnotherapy are on the rise (19). Reflecting a growing understanding about patient-reported experience and pathophysiologic mechanisms, accurate identification and multifaceted treatment are paramount for care of pediatric patients with functional esophageal disorders.…”