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Hypnotherapy for chronic idiopathic nausea and functional dyspepsia in children.


- candidate number24422
- NTR NumberNTR5814
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jun-2016
- Secondary IDsNL51167.100.15 
- Public TitleHypnotherapy for chronic idiopathic nausea and functional dyspepsia in children.
- Scientific TitleMulticenter, Randomised, Controlled Trial of Gut-directed Hypnotherapy or Standard Medical Therapy in Children with Functional Nausea or Functional Dyspepsia
- ACRONYMHyena trial
- hypothesisGut-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
- Healt Condition(s) or Problem(s) studiedFunctional heartburn, Nausea
- Inclusion criteriaChildren 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 criteriaExclusion 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jun-2016
- planned closingdate30-jun-2019
- Target number of participants100
- InterventionsPatients 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.
- Primary outcomeThe primary outcome is the number of patients with > 50% reduction of their nausea
- Secondary outcomeSecondary 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.
- TimepointsPrimary outcome: At 12 months follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIES Pamela Browne
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Christine Bader Fonds
- PublicationsN/A
- Brief summaryBACKGROUND
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.
- Main changes (audit trail)
- RECORD7-jun-2016 - 22-jun-2016


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