Migraine and Recurrent Abdominal Pain in Children
Recruitment status was: Recruiting
Behavioral: thermal biofeedback
Behavioral: relaxation training
Behavioral: cognitive coping skills
Behavioral: parent education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Treatment of Recurrent Pain Syndromes in Children|
|Study Start Date:||May 1999|
|Estimated Study Completion Date:||June 2004|
Recurrent pain syndromes (RPS) are relatively common in pediatric populations. Two of the most common types of RPS are recurrent abdominal pain (RAP) and migraine. Similar patterns of pain are described in children with RAP and migraine, and similar factors (particularly stress) may initiate both types of RPS.
This study will assess a new biobehavioral model for evaluating and treating children with RPS. This model relates precipitating, intervening, and functional status factors in chronic and recurring pain in children. The model proposes that stress is a precipitant of pain. This study will evaluate the model in children who receive therapy for RPS that is based on stress management strategies. The therapy includes relaxation training, cognitive coping skills training, thermal biofeedback, and parent education. It will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy.
Consenting participants will be randomized to receive either biobehavioral therapy or control therapy. Participants will have 6 study visits over the course of 2 months. The first study visit is an evaluation visit; the remaining five study visits are treatment visits. Participants will be followed for 24 months and will be asked to complete mail-in forms at Months 3, 6, 12, and 24.
Participants will be recruited through local pediatricians, pediatric neurologists, and pediatric gastroenterologists. Brochures about the study will be sent to these physicians to pass on to their patients informing them about the study. Children in the control group will be recruited through Children's Hospital outpatient clinics.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060619
|United States, Massachusetts|
|Pain Treatment Service, Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lisa Scharff, Ph.D.||Harvard University|