Migraine and Recurrent Abdominal Pain in Children
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|ClinicalTrials.gov Identifier: NCT00060619|
Recruitment Status : Unknown
Verified March 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : May 12, 2003
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Migraine Abdominal Pain||Behavioral: thermal biofeedback Behavioral: relaxation training Behavioral: cognitive coping skills Behavioral: parent education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment of Recurrent Pain Syndromes in Children|
|Study Start Date :||May 1999|
|Study Completion Date :||June 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060619
|United States, Massachusetts|
|Pain Treatment Service, Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Lisa Scharff, Ph.D. 617-355-2470 firstname.lastname@example.org|
|Contact: Clorinda Schenck 617-355-8973 email@example.com|
|Principal Investigator:||Lisa Scharff, Ph.D.||Harvard University|