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ID
Source
Brief title
Health condition
Functional nausea, chronic idiopathic nausea, functional dyspepsia
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the number of patients with > 50% reduction of their nausea
Secondary outcome
Secondary outcomes: presence of dyspeptic symptoms, change in quality of life scores, change in Health Utility Index, change in depression and anxiety scores, change in the child’s school absences, and use of medication during the treatment.
Background summary
BACKGROUND
Chronic idiopathic nausea (CIN) and functional dyspepsia (FD) are common disorders in children. They are associated with substantial physical and psychosocial distress, as well as school absences and decreased social functioning. The treatment of nausea in CIN and FD in pediatric patients is mostly symptomatic with patients often using prokinetics and/ or anti-emetics for years. In adults gut-directed hypnotherapy has been shown to be a promising treatment option.
AIM:
To investigate the effectiveness of gut-directed hypnotherapy (HT) for reduction of complaints of nausea in children with CIN or FD.
METHODS:
The study population consists of 100 children between 8 and 18 years clinically diagnosed with functional nausea by a paediatrician, either due to chronic idiopathic nausea or functional dyspepsia according to the Rome IV criteria.
Children will receive either 6 sessions of gut-directed HT during 3 months or SMT consisting of antiemetics and prokinetics + 6 sessions of supportive therapy during 3 months. The main outcome parameter is the number of patients with > 50% reduction of their nausea after one year follow-up. Severity and incidence of functional nausea is scored using 7-day diary cards and validated paediatric facial analogue scales for measuring nausea. The secondary outcomes include: quality of life, health utility index, depression, anxiety and somatisation, absence of school, use of health care resources and additional costs, use of medication.
Study objective
Gut-directed hypnotherapy compared to standard medical treatment leads to a substantial reduction in symptoms of nausea in children clinically diagnosed with chronically idiopathic nausea and/or functional dyspepsia
Study design
Primary outcome: At 12 months follow-up.
Intervention
Patients will be randomly allocated to either 6 sessions of gut-directed hypnotherapy (HT) during 3 months or standard medical treatment (SMT) consisting of antiemetics and prokinetics + 6 sessions of supportive therapy during 3 months.
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
Inclusion criteria
Children between 8 and 18 years clinically diagnosed with functional nausea by a paediatrician, either due to chronic idiopathic nausea or functional dyspepsia according to the Rome IV criteria.
Exclusion criteria
Exclusion criteria will be a concomitant organic gastrointestinal disease, simultaneous treatment by another health care professional for the nausea, mental retardation and insufficient knowledge of the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5492 |
| NTR-old | NTR5814 |
| CCMO | NL51167.100.15 |
| OMON | NL-OMON46845 |