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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 14, 2005 | ||||||||
| Last Updated Date | May 29, 2008 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00195975 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Heart Rate Variability in Children With a Functional Gastrointestinal Disorder | ||||||||
| Official Title ICMJE | Heart Rate Variability in Children With Abdominal Pain Related to a Functional Gastrointestinal Disorder: Relationship to Anxiety/Stress, Electrogastrography, and Rapid Water Loading | ||||||||
| Brief Summary | The current study is designed to assess relationships between anxiety/stress, autonomic nervous system balance, and electrical activity in the stomach before and after eating/drinking in children with abdominal pain. |
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| 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 (e.g. 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 body's ability to respond electrically to food/water consumption. However, the relationships between chronic stress/anxiety, ANS balance/imbalance, and electrical activity in the stomach before and after eating/drinking 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 anxiety/stress (i.e., BASC parent- and self-reports) along with ANS balance (i.e., heart rate variability) and electrical activity in the stomach (i.e., 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE | Abdominal Pain | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 75 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
NOTE: Control subjects will meet all patient inclusion/exclusion criteria except for Inclusion Criteria #2. Control subjects will be excluded for history of abdominal pain, nausea, vomiting, diarrhea, constipation, or bloating. |
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| Gender | Both | ||||||||
| Ages | 8 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00195975 | ||||||||
| Responsible Party | Jennifer Verrill Schurman, Ph.D./Principal Investigator, Children's Mercy Hospital | ||||||||
| Study ID Numbers ICMJE | 00005085 | ||||||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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