Recruiting

Observational Study

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00060619

Conditions

Migraine

Abdominal Pain

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

thermal biofeedback

relaxation training

cognitive coping skills

parent education

Study Details

Brief summary:

This study will evaluate a new model for assessing and treating migraine and recurrent abdominal pain in children. The model combines behavioral techniques such as relaxation training with biologic components such as thermal biofeedback.

Conditions

Migraine

Abdominal Pain

Study ID

NCT00060619

Start date

May, 1999

Status verified date

Mar, 2003

Completion date

Jun, 2004

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Inclusion Criteria

  • Migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month
  • Child assent
  • Parental consent

Exclusion Criteria

  • Medical illnesses that cause similar pain symptoms (e.g., inflammatory bowel disease, brain cancer)
  • Psychiatric diagnosis that would interfere with participation in the study (any Axis I diagnosis of moderate severity)

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

thermal biofeedback

relaxation training

cognitive coping skills

parent education

Central Contacts and Locations

Locations

Pain Treatment Service, Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Lisa Scharff, Ph.D.

617-355-2470lisa.scharff@tch.harvard.edu

Clorinda Schenck

617-355-8973clorinda.schenck@tch.harvard.edu

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Jun 24, 2005

Last verified

Mar, 2003

Keywords

  • Migraine
  • Functional abdominal pain
  • Biofeedback
  • Psychological assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2005-06-24.