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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124501
• Other study ID #: 00003103
• 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

• Abdominal Pain
• Duodenitis

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