The Treatment of Recurrent Abdominal Pain in Children

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

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

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Abdominal Pain
• Intervention / Treatment: Behavioral: Biofeedback; Behavioral: Behavioral Protocol

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Kaiser Permanente Vandever Medical Offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biofeedback; heart rate variability biofeedback	Behavioral: Biofeedback; Biofeedback will teach resonant frequency breathing for 6-8 sessions; Other Names: resonant frequency breathing
Active Comparator: Behavioral; 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; Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions; Other Names: relaxation, distraction, and coping statements

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Warren L Shapiro, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Biofeedback; Recurrent Abdominal Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Signs and Symptoms, Digestive; Recurrence; Abdominal Pain
• Other Study ID Numbers: KPSC IRB #5275