The aim of this study is to find a succesful treatment for functional abdominal pain in children and at the same time improve the quality of life of these children. A second aim is to reduce the hospital visits and with that the costs.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are the percentages of patients with complete
remission of functional abdominal pain after the treatment phase
(t = 1) and at six months follow up (t = 2). 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.
Secondary outcome
Secondary outcome measures are pain intensity score, pain frequency scores and
the results of the Kidscreen questionnaire.
Background summary
Recurrent abdominal pain is present in 0.3-19% of school-going children in the
US and Europe and in 1.8-4.6% in Dutch school-going children. This is one of
the most frequent reasons to visit a pediatrician1. This type of abdominal pain
is often functional, i.e. no organic cause is found to explain the symptoms. In
almost 30% of patients with chronic or recurrent abdominal pain, pain persists
for more than 5 years, despite frequent medical attention.
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 and adult as well as pediatric patients are
often referred for additional psychological or behavioural therapy.
The relaxation-based therapy, hypnotherapy, has shown to be more effective than
standard medical therapy in children with Functional Abdominal Pain (FAP) or
Irritable Bowel Syndrome (IBS). One other type of complementary therapy that
has been receiving more attention recently is yoga therapy. Research has shown
that yoga decreases stress, including psychological and physical symptoms.
In 2008 we performed a pilot study, in which 20 children, aged 8-18 years, with
Irritable Bowel Syndrome (IBS) or Functional Abdominal Pain (FAP) were enrolled
and received 10 yoga lessons.
We showed that yoga exercises are effective for children aged 8-18 years with
FAP, resulting in significant reduction of pain intensity and frequency,
especially in children of 8-11 years old.
Although the result of the pilot study are promising, there is a need to
further investigate and confirm the effects of yoga on children with abdominal
pain with a randomized controlled study. The lack of effective therapies for
FAP, the lower quality of life and frequent school absence as result of FAP are
strong arguments in favor of this study. Yoga is simple, can be easily applied
at home, and has lower costs than hypnotherapy.
Study objective
The aim of this study is to find a succesful treatment for functional abdominal
pain in children and at the same time improve the quality of life of these
children. A second aim is to reduce the hospital visits and with that the
costs.
Study design
65 children in two different age groups (8-11 years and 12-18 years) will be
randomized and receive yoga therapy or standard therapy.
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 will be given by a yoga teacher and the yoga
exercises are created especially for children with abdominal pain.
Standard care will include education about functional abdominal pain by a
paediatrician, advice about fibres and fluid.
Outcomes are assessed at several time points: a t=0 (at baseline; before
randomisation), at t=1 (directly after finishing the treatment period) at t=2
(three months after finishing the treatment period) and at t=3 (9 months after
finishing the treatment period).
We will use the following instruments:
•Abdominal pain diary (APD): Patients will be instructed to score pain
intensity and pain frequency in an abdominal pain diary during the baseline
period (a month prior to t=0), for a month after t = 1, for a month prior to t
= 2 and for a month prior to t= 3. Pain intensity will be scored using the
validated six-face Faces Pain Scale-Revised 12: ranging from 1 (=no pain) to 6
(very much pain) (Fig. 1). Pain frequency will be scored as 0 = no pain, 1 = 0*
20 min of pain, 2 = 20 40 min of pain, 3 = 40*90 min of pain and 4 = more than
90 min of daily pain.
The daily scores will be added up to obtain a pain intensity score (minimum
score of 31 and a maximum score of 186) and a pain frequency score (with a
minimal score of 0 and a maximum score of 124) for these different time points.
•Kidscreen-27: The Kidscreen-27 Quality of Life questionnaire will be
administered to the patients and their parents at t = 0, t = 1, t = 2 and t = 3
with permission of the authors13. The Kidscreen questionnaire is a validated
27-item quality of life screening instrument for children of 8 years and above
and their parents that encompasses physical wellbeing (5 items), psychological
well being (7 items), autonomy and parents (7 items), social support and peers
and school (4 items) functioning. A 5-point response scale is used (low and
high scores indicate low and high health related QoL respectively).
Intervention
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 sessions are a mixture of
classical yoga poses and relaxation exercises in which children learn to relax
with yoga breathing techniques. During and after the treatment period, patients
will be allowed to perform the yoga exercises at home. Patients will be taught
to relax the abdomen and to focus their thoughts on a single topic or good
experience instead of random wandering of thoughts or thinking about negative
experiences. The overall goals of the yoga lessons will be to achieve balance,
flexibility, concentration and relaxation.
Study burden and risks
In our opinion there are no extra risks involving this study. The only extra
burden for the children in the intervention group is the yoga therapy. This
will take 1,5 hours a week and a total of 18 hours in 3 months.
Henri Dunantstraat 1
5223 GZ s-Hertogenbosch
NL
Henri Dunantstraat 1
5223 GZ s-Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL38810.028.11 |
OMON | NL-OMON21105 |