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Sponsored by: |
Children's Mercy Hospital Kansas City |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00195975 |
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.
Condition |
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Abdominal Pain |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Heart Rate Variability in Children With Abdominal Pain Related to a Functional Gastrointestinal Disorder: Relationship to Anxiety/Stress, Electrogastrography, and Rapid Water Loading |
Estimated Enrollment: | 75 |
Study Start Date: | June 2005 |
Groups/Cohorts |
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1
Children with FD
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2
Children with IBS
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3
Children with FD and IBS
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Healthy controls
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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.
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.
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.
Contact: Jennifer V Schurman, Ph.D. | 816-234-3674 | jschurman@cmh.edu |
Contact: Debra Taylor, RN | 816-234-3197 | dtaylor@cmh.edu |
United States, Missouri | |
Children's Mercy Hospital and Clinics | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Debra Taylor, RN 816-234-3197 dtaylor@cmh.edu |
Principal Investigator: | Jennifer V Schurman, PhD | Children's Mercy Hospital |
Responsible Party: | Children's Mercy Hospital ( Jennifer Verrill Schurman, Ph.D./Principal Investigator ) |
Study ID Numbers: | 00005085 |
Study First Received: | September 14, 2005 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00195975 |
Health Authority: | United States: Institutional Review Board |
Abdominal Pain Functional Gastrointestinal Disorders Stress Anxiety Autonomic Nervous System |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Abdominal Pain |
Gastrointestinal Diseases Stress Pain |