Abstract
BackgroundFunctional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data.Methods/DesignIn a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy.DiscussionThis confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored.Trial registrationDRKS00005038 (date: 25 July 2013); NCT02030392 (date: 7 January 2014)Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-357) contains supplementary material, which is available to authorized users.
Highlights
Functional abdominal pain (FAP) is a highly prevalent disease and poses a considerable burden on children and their families
This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP
FAP is highly persistent until adulthood, leading to increased risk of psychiatric disorders
Summary
Functional abdominal pain (FAP) is a highly prevalent disease and poses a considerable burden on children and their families. FAP is highly persistent until adulthood, leading to an increased risk of psychiatric disorders. Functional abdominal pain (FAP) is a chronic pain disorder of the gastrointestinal tract without underlying pathological condition [1]. FAP is characterized by recurrent or persistent pain in the abdomen for more than 2 months, with episodes occurring at least once a week [2]. FAP represents, besides headache, the most common pain syndrome in childhood [3], with prevalence rates ranging from 8.3% [3] up to 45% [2]. FAP often leads to Psychosocial factors in symptom maintenance include inadequate coping styles [10], poor family functioning and overprotective parental behaviors [11]. Catastrophizing plays an especially important role in mediating the relationship between pain and quality of life [6] and moderating the effectiveness of distraction [12]
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