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
ID
Bron
Verkorte titel
Aandoening
Functional nausea, chronic idiopathic nausea, functional dyspepsia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the number of patients with > 50% reduction of their nausea
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Primary outcome: At 12 months follow-up.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL5492 |
NTR-old | NTR5814 |
CCMO | NL51167.100.15 |
OMON | NL-OMON46845 |