Multicentre, Randomised, Controlled Trial of Gut-directed Hypnotherapy or Standard Medical Therapy in Children with Functional Nausea or Functional Dyspepsia

Phase 3

Completed

Conditions: chronic nausea
functional nausea
10017977
10002861

Registration Number: NL-OMON46845

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the proportion of patients with at least 50% reduction<br /><br>in their nausea at 12 months follow-up. Based on our pilot study and the<br /><br>success percentages in studies in adults with functional dyspepsia, using<br /><br>hypnosis in paediatric cancer patients, we expect this percentage in<br /><br>hypnotherapy group to be around 80%. In the standard medical treatment group,<br /><br>we anticipate this percentage to be much lower, around 50%<br /><br>A two group continuity corrected 2 test with a 0,050 two-sided significance<br /><br>level will have 80% power to detect the difference between a Group 1<br /><br>proportion, 1, of 0,80 and a Group 2 proportion, *2, of 0,500 (odds ratio of<br /><br>0,250) when the sample size in each group is 45. With an estimated drop out of<br /><br>10% we will include a total of 100 children.</p><br>

Secondary Outcome Measures