This trial aims to compare two training programs for children suffering functional abdominal pain. These two programs are comparable in number of sessions and group sizes, but show differences in content (very focused on pain management vs. more general information and support). Focus of the trial is the evaluation of "Stop the pain", which has shown high effectiveness in one first trial. This time, five clinics, experienced in diagnosis and treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are eligible. The programs imply six weekly group sessions for the children and 2 parent evenings. The study group assumes that participation in "Stop the pain" will reduce pain experience and will improve the children's quality of life and coping strategies - up to 12 months after training.
The trial aims to assess the efficacy of a cognitive-behavioral self-management program (intervention group, IG) compared to an equally extensive information-only control group (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral, manualized program "Stop the pain with Happy Pingu". Follow up per patient: 3- and 12 months. Children aged 7-12 years suffering functional abdominal pain (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is that for patients in the IG the frequency and intensity of pain will be reduced more successfully and more sustainable than for children in the CG. Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
Cognitive-behavioral intervention
Education and information
University Medical Center, Pediatric Gastroenterology
Berlin, Germany
Children's Hospital "Prinzessin Margaret", Pediatric Gastroenterology
Darmstadt, Germany
University Medical Center, Pediatric Gastroenterology
Düsseldorf, Germany
Catholic Children's Hospital Hamburg Wilhelmstift
Hamburg, Germany
St. Vincenz Hospital
Paderborn, Germany
University Medical Center, Pediatric Gastroenterology
Ulm, Germany
Change in Pain Symptoms
Primary efficacy endpoint is the frequency and intensity of pain (composite score) over the course of treatment and follow-up (pre, post, 3 and 12 months follow-up). This primary outcome will be assessed by pain diary in children's self-report (over 2 weeks).Statistically, the primary endpoint of the study is defined as the change of the logarithm of the area under the pain-intensity curve over one week from start of treatment to 12 month follow-up. The area under the pain intensity curve (auc) is a measure that reflects pain intensity as well as pain duration and pain frequency and thus can be understood as a composite measure of pain.
Time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Pain-related impairment
A measure for child's functional disability due to pain. The measure is one scale score and covers the level of impairment in everyday activitites due to abdominal pain by 12 items, e.g. reading, meeting friends, family life. The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Health-related quality of life
The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
Pain-related coping and cognitions
The secondary outcome variable will be assessed by self-report questionnaire (pre, post, 3- and 12 months follow-up).
Time frame: up to 21 days pre intervention, up to 21 days post intervention, 3 month-follow-up, 12 month-follow-up
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