Children with chronic abdominal pain that received yoga treatment additional to standard care will show less abdominal pain compared to children that received only standard care.
ID
Bron
Verkorte titel
Aandoening
chronic abdominal pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The reduction of abdominale pain is our primairy outcome. Abdominale
pain is measured by an abdominal pain diary. Patients will be instructed
to score pain intensity and pain frequency during 1 month at baseline
period, after finishing the treatment and at 6 and 12 months follow up.
Clinical remission is defined as a decrease of the pain intensity score
and pain frequency score of > 80%; significant improvement is defined as
a decrease of pain intensity score and pain frequency score between 30%
and 80% and treatment is considered unsuccessful if the scores improved
< 30% or got worse.
Achtergrond van het onderzoek
Background: Chronic abdominal pain is a common problem of school-going
children and is one of the most frequent reasons to visit a
pediatrician. Abdominal pain is often associated with other somatic
complaints such as headache, back and limb pain. These pain symptoms
lead to low quality of life and frequent school absence. The benefits of
standard treatment (reassurance, dietary manipulation) and of
pharmacological therapy are limited. Several studies have shown that
psychological distress is strongly associated with abdominal pain in
children, not just as a consequence of the pain, but probably also as a
predictor of symptoms. Research has shown that yoga decreases stress,
including psychological and physical symptoms.
Aim: The aim of this study is to compare the effect of yoga exercises
and standard care on pain frequency, intensity and quality of life in
children with functional abdominal pain.
Methods: 65 children, aged 8-18 years with chronic abdominal pain will
be randomized to one of these treatments: yoga therapy additional to
standard care or standard care alone. Primary outcomes are the
percentages of patients with complete remission of chronic abdominal
pain after the treatment phase and at six and twelve months follow up.
Secondary outcome are changes in quality of life.
Doel van het onderzoek
Children with chronic abdominal pain that received yoga treatment additional to standard care will show less abdominal pain compared to children that received only standard care.
Onderzoeksopzet
Outcomes are assessed at:
t=0 baseline; before randomisation;
t=1 directly after finishing the treatment;
t=2 six months follow up;
t=3 twelve months follow up.
Onderzoeksproduct en/of interventie
Yoga therapy will be given in groups of 7- 8 children per group, in which patients will receive one treatment session each week for 3 months. These hatha yoga sessions of 1.5 h each will be provided by a children’s yoga teacher. The sessions are based on classic Hatha yoga principles in combination with specialized yoga exercises for children.
The control group will receive treatment as usual (information about the disorder and dietary advice).
Algemeen / deelnemers
J.J. Korterink
Henri Dunantstraat 1
5223 GZ 's-Hertogenbosch
Den Bosch 5200 ME
The Netherlands
+31 (0)73 5337932
j.korterink@jbz.nl
Wetenschappers
J.J. Korterink
Henri Dunantstraat 1
5223 GZ 's-Hertogenbosch
Den Bosch 5200 ME
The Netherlands
+31 (0)73 5337932
j.korterink@jbz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Children aged 8-18 years are included if they meet the criteria for functional dyspepsia, IBS, functional abdominal pain (FAP) or abdominal migraine, based on the Rome III Criteria for Functional Bowel Disorders Associated with Abdominal Pain or Discomfort in Children.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Children with abdominal pain as result of inflammatory, anatomic, metabolic or neoplastic disease. Children who already participated in yoga therapy, hypnotherapy, psychotherapy or any form of relaxation therapy for functional abdominal pain in the past. Children with mental retardation.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3142 |
NTR-old | NTR3286 |
CCMO | NL38810.028.11 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON37663 |