The Treatment of Recurrent Abdominal Pain in Children

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

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.

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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.

Conditions

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Recurrent Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biofeedback

heart rate variability biofeedback

Group Type ACTIVE_COMPARATOR

Biofeedback

Intervention Type BEHAVIORAL

Biofeedback will teach resonant frequency breathing for 6-8 sessions

Behavioral

Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements

Group Type ACTIVE_COMPARATOR

Behavioral Protocol

Intervention Type BEHAVIORAL

Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions

Interventions

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Biofeedback

Biofeedback will teach resonant frequency breathing for 6-8 sessions

Intervention Type BEHAVIORAL

Behavioral Protocol

Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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resonant frequency breathing relaxation, distraction, and coping statements

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No