NL-OMON46845CompletedPhase 3
Multicentre, Randomised, Controlled Trial of Gut-directed Hypnotherapy or Standard Medical Therapy in Children with Functional Nausea or Functional Dyspepsia - Hyena (HYpnotherapy & NAusea)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
Inclusion Criteria
- •Children aged 8 to 18 years who are diagnosed with functional nausea for at least 2 months due to chronic idiopathic nausea or functional dyspepsia will be included. . To exclude underlying organic diseases, all children will undergo routine laboratory testing before inclusion: complete blood cell count, C-reactive protein, liverfunctions, creatinine, total bilirubin, amylase, celiac screening (anti-transglutaminase antibodies and IgA), urinalysis, stool parasite analysis, H pylori antigens in stool. Gastric emptying tests will be performed to verify the functional nature of the nausea. The need for further diagnostic testing, such as a upper endoscopy to rule out eosinophilic esophagitis or 24h pH measuring will be left to the discretion of the treating paediatrician or paediatric gastroenterologist.
Exclusion Criteria
- •Exclusion criteria will be a concomitant organic gastrointestinal disease, treatment by another health care professional for the nausea, mental retardation and insufficient knowledge of the Dutch language.
Investigators
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