chronic nausea functional nausea
Conditions
Interventions
Patients will be randomly allocated using a computerized random-number
generator for concealment to gut-directed hypnotherapy given by a therapist
(group A) or standard medical treatment + supportiv
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of patients with at least 50% reduction in their nausea at 12 months follow-up. Based on our pilot study and the success percentages in studies in adults with functional dyspepsia, using hypnosis in paediatric cancer patients, we expect this percentage in hypnotherapy group to be around 80%. In the standard medical treatment group, we anticipate this percentage to be much lower, around 50% A two group continuity corrected *2 test with a 0,050 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion, *1, of 0,80 and a Group 2 proportion, *2, of 0,500 (odds ratio of 0,250) when the sample size in each group is 45. With an estimated drop out of 10% we will include a total of 100 children. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes are: 1. Quality of life scores (measured by KIDSCREEN-52 questionnaire), assessed at baseline, after treatment and at 6 and 12 months follow-up. Questionnaires needs to be filled out by the patients. 2. Health Utility Index (suited for valuation of health states of children > 6 years), assessed at baseline, after treatment and at 6 and 12 months. This questionnaire needs to be filled out by the parents. 3. Depression and anxiety scores (RCADS-25), measured at baseline, end of treatment, 6 and 12 months. Questionnaires needs to be filled out by the patients. 4. School absence (child), absence from work (parents) during the first year after treatment. Also use of medication, doctor visits and costs of treatment will be monitored during the first year after treatment. This questionnaire needs to be filled out by the parents. 5. The proportion of patients with at least 50% reduction in their nausea after treatment and at 6 months follow-up. | — |
Countries
Netherlands
Outcome results
None listed