Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
1999-05-31
2004-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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thermal biofeedback
relaxation training
cognitive coping skills
parent education
Eligibility Criteria
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Inclusion Criteria
* Child assent
* Parental consent
Exclusion Criteria
* Psychiatric diagnosis that would interfere with participation in the study (any Axis I diagnosis of moderate severity)
7 Years
17 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Lisa Scharff, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Harvard University
Locations
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Pain Treatment Service, Children's Hospital
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Lisa Scharff, Ph.D.
Role: primary
Clorinda Schenck
Role: backup
References
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Blanchard EB, Scharff L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Clin Psychol. 2002 Jun;70(3):725-38. doi: 10.1037//0022-006x.70.3.725.
Scharff L, Marcus DA, Masek BJ. A controlled study of minimal-contact thermal biofeedback treatment in children with migraine. J Pediatr Psychol. 2002 Mar;27(2):109-19. doi: 10.1093/jpepsy/27.2.109.
Di Lorenzo C, Youssef NN, Sigurdsson L, Scharff L, Griffiths J, Wald A. Visceral hyperalgesia in children with functional abdominal pain. J Pediatr. 2001 Dec;139(6):838-43. doi: 10.1067/mpd.2001.118883.
Other Identifiers
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5R01HD38647-3
Identifier Type: -
Identifier Source: org_study_id