The Treatment of Recurrent Abdominal Pain in Children

Recurrent Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00852878
• Other study ID #: KPSC IRB #5275
• Status: Withdrawn
• Phase: N/A
• First received: February 26, 2009
• Last updated: June 19, 2015
• Start date: March 2009

Study information

• Verified date: December 2010
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Recurrent Abdominal Pain

Intervention

Behavioral:
• Biofeedback
Biofeedback will teach resonant frequency breathing for 6-8 sessions
• Behavioral Protocol
Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions

Locations

Country	Name	City	State
United States	Kaiser Permanente Vandever Medical Offices	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A measurable secondary outcome will be changes in heart rate variability		3 Months	No