Expired Study
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Kansas City, Missouri 64108


Purpose:

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).


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

00003103


NCT ID:

NCT00124501


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis: Pilot Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

8 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Mercy Hospital Kansas City


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer V Schurman, Ph.D.
Principal Investigator
Children's Mercy Hospital

Study Dates

Start Date:October 2004
Completion Date:August 2006
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 29, 2008
First Received Date:July 26, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection)
Time Frame:Up to 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Functional disability rating scale at 6 weeks, 3 months, and 6 months
Time Frame:6 weeks, 3 months, and 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months
Time Frame:6 weeks, 3 months, and 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in salivary cortisol at 6 weeks, 3 months, and 6 months
Time Frame:6 weeks, 3 months, and 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Time Frame:6 weeks, 3 months, and 6 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Biofeedback-assisted relaxation training
Description:10 sessions BART
Arm Name:SMT

Study Arms

Study Arm Type:Active Comparator
Arm Name:SMT
Description:Standard Medication Treatment
Study Arm Type:Experimental
Arm Name:BART
Description:Biofeedback-assisted Relaxation Training plus SMT

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Mercy Hospital Kansas City

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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