Recurrent Abdominal Pain
Conditions
Keywords
Recurrent Abdominal Pain, Biofeedback, Heart Rate Variability
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.
Interventions
BEHAVIORALBiofeedback
Biofeedback will teach resonant frequency breathing for 6-8 sessions
BEHAVIORALBehavioral Protocol
Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| A measurable secondary outcome will be changes in heart rate variability | 3 Months |
Countries
United States
Outcome results
None listed