The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent Abdominal Pain
- Sponsor
- Kaiser Permanente
- Locations
- 1
- Primary Endpoint
- The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.
Detailed Description
Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •who speak English
- •diagnosis with Recurrent abdominal pain
Exclusion Criteria
- •lactose intolerance, urinary tract infections, or recent head trauma;
- •the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
- •currently receiving other treatment for recurrent abdominal pain;
- •the receipt of a recent and related surgical procedure;
- •children who met criteria for depression or anxiety disorder
Outcomes
Primary Outcomes
The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
Time Frame: 3 Months
Secondary Outcomes
- A measurable secondary outcome will be changes in heart rate variability(3 Months)