The Treatment of Recurrent Abdominal Pain in Children

This study has been withdrawn prior to enrollment.
(Not enough interested participants)
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00852878
First received: February 26, 2009
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention
Recurrent Abdominal Pain
Behavioral: Biofeedback
Behavioral: Behavioral Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A measurable secondary outcome will be changes in heart rate variability [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852878

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

No publications provided

Responsible Party: Dr. Warren Shapiro, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00852878     History of Changes
Other Study ID Numbers: KPSC IRB #5275
Study First Received: February 26, 2009
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 30, 2014