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

NCT ID: NCT00124501

Last Updated: 2008-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Abdominal Pain Duodenitis

Keywords

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Biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SMT

Standard Medication Treatment

Group Type ACTIVE_COMPARATOR

Biofeedback-assisted relaxation training

Intervention Type BEHAVIORAL

10 sessions BART

BART

Biofeedback-assisted Relaxation Training plus SMT

Group Type EXPERIMENTAL

Biofeedback-assisted relaxation training

Intervention Type BEHAVIORAL

10 sessions BART

Interventions

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Biofeedback-assisted relaxation training

10 sessions BART

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Children's Mercy Hospital

Principal Investigators

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Jennifer V Schurman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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00003103

Identifier Type: -

Identifier Source: org_study_id