Functional Abdominal Pain Syndrome | A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Functional Abdominal Pain Syndrome research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion criteria for medical screening: - aged 7-12 years - abdominal pain for at least 2 months - abdominal pain at least once per week - unclear cause for abdominal pain exclusion criteria for medical screening: - very limited German language skills - mental retardation - adjuvant psychological treatment at point of medical screening - participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening - participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening - at point of medical screening: therapy or medication for abdominal pain - presentation of sibling aged 7-12 years Inclusion Criteria for study participation: - pain-predominant functional gastrointestinal disorders according to Rome-III - criteria (H2a, H2b, H2d, H2d1) - informed consent for study particiaption - informed consent for audiotaping of trainings sessions - no time constraints for participation in training groups Exclusion Criteria for study participation: - psychiatric disorder (internalizing) with primary treatment indication - severe externalizing disorder
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Functional Abdominal Pain Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Intervention groupCognitive-behavioral intervention
Behavioral:Active control groupEducation and information
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Intervention groupIG participation in the cognitive-behavioral program "Stop the pain with Happy Pingu". The program compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each).
Active control groupCG participation in an information and education control group (physical well-being, health and gastrointestinal tract). The program of the control group compromises six weekly sessions for the children in small groups (90 min each) and 2 sessions for the parents (90 min each).
Start Date: March 31, 2014
Completed Date: July 7, 2017
Primary Outcome: Change in Pain Symptoms
Secondary Outcome: Pain-related impairment
Study sponsors, principal investigator, and references
Principal Investigator: Petra Warschburger, Professor
Lead Sponsor: University of Potsdam
Groß M, Warschburger P. Evaluation of a cognitive-behavioral pain management program for children with chronic abdominal pain: a randomized controlled study. Int J Behav Med. 2013 Sep;20(3):434-43. doi: 10.1007/s12529-012-9228-3.