Heart Rate Variability in Children With a Functional Gastrointestinal Disorder

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: NCT00195975
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 28, 2011
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease
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 (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.

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: 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
Study Start Date : June 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Children with FD
Healthy controls

Primary Outcome Measures :
  1. HRV or the magnitude of power in the LF or HF in the fasting or post-prandial state [ Time Frame: Same day ]
  2. HRV or stress profile parameters following an acute stress(mental math) [ Time Frame: Same day ]
  3. Frequency of an abnormal EGG or the magnitude of EGG parameters [ Time Frame: Same day ]
  4. Water load volume [ Time Frame: Same day ]

Secondary Outcome Measures :
  1. Behavioral Assessment System for Children (BASC) [ Time Frame: Same day ]
  2. Salivary cortisol [ Time Frame: Same day ]
  3. A stress profile via the biofeedback equipment (e.g. measures of muscle tension, hand temperature, and skin moisture (conductance). [ Time Frame: Same day ]

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.

Inclusion Criteria:

  • Ages 8 - 17 years
  • Evaluated in Abdominal Pain Clinic at Children's Mercy Hospital or the Gastroenterology Clinic at Children's Mercy South for abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for FD, IBS, or FD/IBS.

Exclusion Criteria:

  • Previous abdominal surgery
  • Chronic disease requiring regular medical care (e.g. gastrointestinal diseases, diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer).
  • Non-English speaking

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.

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): NCT00195975

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

Responsible Party: Jennifer Verrill Schurman, Ph.D./Principal Investigator, Children's Mercy Hospital Identifier: NCT00195975     History of Changes
Other Study ID Numbers: 00005085
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Children's Mercy Hospital Kansas City:
Abdominal Pain
Functional Gastrointestinal Disorders
Autonomic Nervous System

Additional relevant MeSH terms:
Abdominal Pain
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive