The aim of this study is to compare gut-directed hypnotherapy with standard medical treatment in children and adolescents with chronic idiopathic nausea or nausea due to functional dyspepsia. We will examine the effect of these treatments on…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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 using prokinetics and/ or anti-emetics for
years. In adults gut-directed hypnotherapy has been shown to be a promising
treatment option. In children with chronic nausea its efficacy has not been
studied yet.
Study objective
The aim of this study is to compare gut-directed hypnotherapy with standard
medical treatment in children and adolescents with chronic idiopathic nausea or
nausea due to functional dyspepsia.
We will examine the effect of these treatments on reduction of severity and
frequency of nausea, vomiting, quality of life, anxiety and depression, school
absence, parental work absence and use of health care sources. Costs and
effectiveness will be compared in order to answer the question which therapy
should become the treatment of choice for children with CIN or FD.
Study design
Multicentre radomized controlled trial comparing gut-directed hypnotherapy with
standard medical treatment + 6 sessions supportive therapy to correct for the
aspecific effect of patient-therapist time.
Intervention
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 + supportive therapy (group B).
Hypnotherapy will be carried out by one of six participating experienced
hypnotherapists and will consist of 6 sessions of 50 minutes over a 3-month
period. A variant of our gut-directed hypnotherapy protocol will be applied.
This protocol has been used in our pilot study and contains exercises aiming
for normalization of the gastric motility, stress reduction and ego
strengthening exercises.
Children assigned to group B will visit their treating physician 6 times over a
3-month period. They will follow the standard AMC treatment protocol for
children with functional nausea/ functional dyspepsia. This AMC protocol
consists of education and reassurance, prokinetic agents, protonpump
inhibitors, and/ or anti-emetic medication if considered necessary. Moreover
they will receive 6 half hour sessions of supportive therapy, given by a their
treating physician or physician assistant, depending on the local hospital. In
these sessions symptoms of the previous weeks will be discussed with an
exploration of possible contributory triggers like dietary products, emotional
problems and stressful events. This supportive therapy is added to correct for
aspecific treatment effects and patient-therapist time.
Study burden and risks
Burden, risks and benefits :
1. Control group: During the study children in the control group will visit the
hospital 6 times, which is more often than in usual care for CIN and FD.
Besides the obvious disadvantage of these visits (time spent by parents and
patient), there is also an advantage. It is known from other studies that extra
time invested by health care professionals results in better outcome. The
children in the control group will receive standard medication for functional
dyspepsia and nausea and therefore we expect no extra risks in the control
group.
2. Hypnotherapy group: The children in the hypnotherapy group will visit the
hypnotherapist 6 times. Moreover, they will be asked to practice self-hypnosis
everyday for 10 to 15 minutes. So they will invest more time than the children
in the control group. Previous studies with hypnotherapy in children have not
resulted in adverse events, besides some dizziness during or after the
exercises in a few children. This dizziness was self-limiting and usually
occurred only during the first session. The benefit of the participants in this
group, is that studies in adults have shown that hypnotherapy may result in
long term disappearance of symptoms without the need for medication use.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51167.100.15 |
| OMON | NL-OMON25887 |