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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00124501
Other study ID # 00003103
Secondary ID
Status Completed
Phase N/A
First received July 26, 2005
Last updated May 29, 2008
Start date October 2004
Est. completion date August 2006

Study information

Verified date May 2008
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Biofeedback-assisted relaxation training
10 sessions BART

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection) Up to 6 months No
Secondary Functional disability rating scale at 6 weeks, 3 months, and 6 months 6 weeks, 3 months, and 6 months No
Secondary Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months 6 weeks, 3 months, and 6 months No
Secondary Changes in salivary cortisol at 6 weeks, 3 months, and 6 months 6 weeks, 3 months, and 6 months No
Secondary 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 No
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