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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00124501
First received: July 26, 2005
Last updated: May 29, 2008
Last verified: May 2008
  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).


Condition Intervention
Abdominal Pain
Duodenitis
Behavioral: Biofeedback-assisted relaxation training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis: Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional disability rating scale at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • Changes in salivary cortisol at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SMT
Standard Medication Treatment
Behavioral: Biofeedback-assisted relaxation training
10 sessions BART
Experimental: BART
Biofeedback-assisted Relaxation Training plus SMT
Behavioral: Biofeedback-assisted relaxation training
10 sessions BART

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124501

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Jennifer V Schurman, Ph.D. Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Jennifer Verrill Schurman, Ph.D./Principal Investigator, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00124501     History of Changes
Other Study ID Numbers: 00003103
Study First Received: July 26, 2005
Last Updated: May 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Biofeedback

Additional relevant MeSH terms:
Abdominal Pain
Duodenitis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014