The Treatment of Recurrent Abdominal Pain in Children

Kaiser Permanente

Status: Withdrawn

Conditions: Recurrent Abdominal Pain

Treatments: Behavioral: Biofeedback; Behavioral: Behavioral Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00852878

KPSC IRB #5275

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Biofeedback

Active Comparator group

Description:

heart rate variability biofeedback

Treatment:

Behavioral: Biofeedback

Behavioral

Active Comparator group

Description:

Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements

Treatment:

Behavioral: Behavioral Protocol