An interventional study of Biofeedback and Behavioral Protocol in Recurrent Abdominal Pain, sponsored by Kaiser Permanente. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.
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.
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Exclusion Criteria:
heart rate variability biofeedback
Behavioral: Biofeedback
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
Biofeedback will teach resonant frequency breathing for 6-8 sessions
Also known as: resonant frequency breathing
Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions
Also known as: relaxation, distraction, and coping statements
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
A measurable secondary outcome will be changes in heart rate variability
Time frame: 3 Months
This study is withdrawn, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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