Back to resultsThe Treatment of Recurrent Abdominal Pain in Children
Primary Purpose
Recurrent Abdominal Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback
Behavioral Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Abdominal Pain focused on measuring Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability
Eligibility 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
Sites / Locations
- Kaiser Permanente Vandever Medical Offices
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Biofeedback
Behavioral
Arm Description
heart rate variability biofeedback
Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements
Outcomes
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
Secondary Outcome Measures
A measurable secondary outcome will be changes in heart rate variability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00852878
Brief Title
The Treatment of Recurrent Abdominal Pain in Children
Official Title
The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough interested participants
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Abdominal Pain
Keywords
Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Active Comparator
Arm Description
heart rate variability biofeedback
Arm Title
Behavioral
Arm Type
Active Comparator
Arm Description
Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
resonant frequency breathing
Intervention Description
Biofeedback will teach resonant frequency breathing for 6-8 sessions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Protocol
Other Intervention Name(s)
relaxation, distraction, and coping statements
Intervention Description
Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
A measurable secondary outcome will be changes in heart rate variability
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren L Shapiro, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Vandever Medical Offices
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Treatment of Recurrent Abdominal Pain in Children
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