Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis

Not Applicable

Completed

• Conditions: Duodenitis; Abdominal Pain
• Interventions: Behavioral: Biofeedback-assisted relaxation training

• Registration Number: NCT00124501
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

The purpose of this study is to determine whether the addition of Biofeedback-Assisted Relaxation to standard medication treatment improves outcomes for children with a specific type of recurrent abdominal pain (i.e., eosinophilic gastroenteritis).

Detailed Description

Recurrent abdominal pain (RAP) is the most common type of pain in school age children and young adolescents. Previous studies suggest that stress plays an important role in the activation of specific cells that can produce pain within the stomach and intestines. Medication is the standard approach to the treatment of RAP in children. Although medication is helpful for many children, medication alone is not always enough. Biofeedback trains individuals to use relaxation strategies effectively to relieve emotional and physical symptoms, and has been used successfully for stress and pain reduction with both children and adults. It has shown promising results when used alone in the treatment of children with RAP. Research is needed, however, to determine whether biofeedback training is helpful when used in conjunction with medication. Information about how biofeedback training affects the central nervous system and the cells that produce pain also would be useful in refining treatments for this large group of children. The current research will be done in three steps, with Phase 1 designed to evaluate the time, resources, technical support, and sample size needed for successful completion of the full research study. Twenty children (ages 8-18) with eosinophilic duodenitis, a specific form of RAP, will be enrolled and randomly assigned to one of two groups: 1) Standard of Care; or 2) Biofeedback (standard medical care plus 10 sessions of biofeedback training). Measures of pain, functional disability, quality of life, physiological arousal, and global treatment response will be collected pre- and post-intervention, as well as 3 and 6 months later. Data collected will be used to determine how many participants will be needed for the full research study. If biofeedback training is ultimately found to be a positive addition to standard medical treatment, this could lead to improved health outcomes for children with RAP. This information also could result in greater treatment efficiency and reduced health care costs for families, insurance providers, and the hospital system.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-28
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-29
• Last Update Posted: 2008-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A current diagnosis of eosinophilic duodenitis per biopsy.
• Ability to participate in the biofeedback training protocol.
• Transportation available to attend twice weekly visits to Children's Mercy Hospital (CMH).

Exclusion Criteria

• Previous biofeedback training.
• Previous failure of medications used as standard of care in this study.
• Allergy to medications prescribed in this study.
• Co-morbid chronic illness requiring regular medical care.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BART	Biofeedback-assisted relaxation training	Biofeedback-assisted Relaxation Training plus SMT
SMT	Biofeedback-assisted relaxation training	Standard Medication Treatment

Primary Outcome Measures

Name	Time	Method
Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection)	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in salivary cortisol at 6 weeks, 3 months, and 6 months	6 weeks, 3 months, and 6 months
Changes in other psychosocial measures (e.g., Behavior Assessment System for Children (BASC), sleep survey, quality of life, etc.) at 6 weeks, 3 months, and 6 months	6 weeks, 3 months, and 6 months
Functional disability rating scale at 6 weeks, 3 months, and 6 months	6 weeks, 3 months, and 6 months
Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months	6 weeks, 3 months, and 6 months

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States