Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124501
Status:
COMPLETED
Last Update Posted:
2008-05-30
First Post:
2005-07-26
Brief Title:
Effectiveness of Biofeedback-Assisted Relaxation Training in Children With Eosinophilic Duodenitis
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
The Impact of Biofeedback-Assisted Relaxation Training on Pain and Functional Disability in Children Diagnosed With Eosinophilic Duodenitis Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie eosinophilic gastroenteritis
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None