Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195975
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2005-09-14
Brief Title:
Heart Rate Variability in Children With a Functional Gastrointestinal Disorder
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Heart Rate Variability in Children With Abdominal Pain Related to a Functional Gastrointestinal Disorder Relationship to AnxietyStress Electrogastrography and Rapid Water Loading
Status:
COMPLETED
Status Verified Date:
2011-06
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 current study is designed to assess relationships between anxietystress autonomic nervous system balance and electrical activity in the stomach before and after eatingdrinking in children with abdominal pain
Detailed Description:
Chronic or recurrent abdominal pain in children is a very common complaint in children and adolescents and is most often associated with the presence of a functional gastrointestinal disorder FGID It is likely that the clinical symptoms in FGIDs are the result of an interaction between biologic psychologic and social factors The psychologic factor most implicated is chronic stress or anxiety Stress may influence gastrointestinal function and symptoms through altering the balance of the autonomic nervous system ANS Imbalance in the ANS has potential effects on gastrointestinal mechanosensitivity motor function eg stomach emptying and accommodation and electrical rhythms All of these can be associated with abdominal pain Theory and early evidence from studies done with healthy adult populations suggest that ANS imbalance can reduce the bodys ability to respond electrically to foodwater consumption However the relationships between chronic stressanxiety ANS balanceimbalance and electrical activity in the stomach before and after eatingdrinking remain to be fully explored in children with FGIDs The current study is a two-part pilot study designed to assess these relationships Part I involves assessment of anxietystress ie BASC parent- and self-reports along with ANS balance ie heart rate variability and electrical activity in the stomach ie electrogastrography measured in the fasting state and following a test meal Part II involves the same assessments with rapid water loading replacing the test meal Results will be analyzed by specific FGID as well as for the group as a whole We expect to enroll 75 children ages 8-17 in each part including 30 healthy controls and 45 children with an FGID Elucidating these relationships is a necessary first step in developing more effective treatments for children with recurrent abdominal pain and ultimately reducing the personal and societal costs of this common pain entity
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