Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis
The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis: Pilot Study
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMay 30, 2008
May 1, 2008
1.8 years
July 26, 2005
May 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection)
Up to 6 months
Secondary Outcomes (4)
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
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
Study Arms (2)
SMT
ACTIVE COMPARATORStandard Medication Treatment
BART
EXPERIMENTALBiofeedback-assisted Relaxation Training plus SMT
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer V Schurman, Ph.D.
Children's Mercy Hospital Kansas City
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
October 1, 2004
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
May 30, 2008
Record last verified: 2008-05