The Treatment of Recurrent Abdominal Pain in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852878
Recruitment Status : Withdrawn (Not enough interested participants)
First Posted : February 27, 2009
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Recurrent Abdominal Pain Behavioral: Biofeedback Behavioral: Behavioral Protocol Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
Study Start Date : March 2009
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Biofeedback
heart rate variability biofeedback
Behavioral: Biofeedback
Biofeedback will teach resonant frequency breathing for 6-8 sessions
Other Name: 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 Name: relaxation, distraction, and coping statements

Primary Outcome Measures :
  1. 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 [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. A measurable secondary outcome will be changes in heart rate variability [ Time Frame: 3 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852878

United States, California
Kaiser Permanente Vandever Medical Offices
San Diego, California, United States, 92120
Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: Warren L Shapiro, MD Kaiser Permanente

Responsible Party: Kaiser Permanente Identifier: NCT00852878     History of Changes
Other Study ID Numbers: KPSC IRB #5275
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: December 2010

Keywords provided by Kaiser Permanente:
Recurrent Abdominal Pain
Heart Rate Variability

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive