The Treatment of Recurrent Abdominal Pain in Children

Not Applicable

Withdrawn

• Conditions: Recurrent Abdominal Pain
• Interventions: Behavioral: Biofeedback; Behavioral: Behavioral Protocol

• Registration Number: NCT00852878
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Study Start: 2009-03
• Primary Completion: 2010-01
• Status Verified: 2010-12
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback	Biofeedback	heart rate variability biofeedback
Behavioral	Behavioral Protocol	Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
A measurable secondary outcome will be changes in heart rate variability	3 Months

Trial Locations

Locations (1)

Kaiser Permanente Vandever Medical Offices; 🇺🇸 San Diego, California, United States