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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124501
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : May 30, 2008
Information provided by:
Children's Mercy Hospital Kansas City

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).

Condition or disease Intervention/treatment Phase
Abdominal Pain Duodenitis Behavioral: Biofeedback-assisted relaxation training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Primary outcomes involve the feasibility of the method (e.g., compliance with daily diary, salivary cortisol collection) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Functional disability rating scale at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ]
  2. Pain ratings on daily diary, at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ]
  3. Changes in salivary cortisol at 6 weeks, 3 months, and 6 months [ Time Frame: 6 weeks, 3 months, and 6 months ]
  4. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124501

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

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Responsible Party: Jennifer Verrill Schurman, Ph.D./Principal Investigator, Children's Mercy Hospital Identifier: NCT00124501    
Other Study ID Numbers: 00003103
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008
Keywords provided by Children's Mercy Hospital Kansas City:
Additional relevant MeSH terms:
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Abdominal Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases
Duodenal Diseases
Intestinal Diseases