The Treatment of Recurrent Abdominal Pain in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention

Conditions
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Recurrent Abdominal Pain

Intervention / Treatment
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* Behavioral: Biofeedback
* Behavioral: Behavioral Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofeedback<br>heart rate variability biofeedback | Behavioral: Biofeedback<br>* Biofeedback will teach resonant frequency breathing for 6-8 sessions<br>* Other names: resonant frequency breathing;|
| Active Comparator: Behavioral<br>Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements | Behavioral: Behavioral Protocol<br>* Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions<br>* Other names: relaxation, distraction, and coping statements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A measurable secondary outcome will be changes in heart rate variability |  | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability