Heart Rate Variability in Children With a Functional Gastrointestinal Disorder

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00195975
First received: September 14, 2005
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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
Abdominal Pain

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • HRV or the magnitude of power in the LF or HF in the fasting or post-prandial state [ Time Frame: Same day ] [ Designated as safety issue: No ]
  • HRV or stress profile parameters following an acute stress(mental math) [ Time Frame: Same day ] [ Designated as safety issue: No ]
  • Frequency of an abnormal EGG or the magnitude of EGG parameters [ Time Frame: Same day ] [ Designated as safety issue: No ]
  • Water load volume [ Time Frame: Same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral Assessment System for Children (BASC) [ Time Frame: Same day ] [ Designated as safety issue: No ]
  • Salivary cortisol [ Time Frame: Same day ] [ Designated as safety issue: No ]
  • A stress profile via the biofeedback equipment (e.g. measures of muscle tension, hand temperature, and skin moisture (conductance). [ Time Frame: Same day ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: June 2005
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children with FD
4
Healthy controls

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195975

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

No publications provided

Responsible Party: Jennifer Verrill Schurman, Ph.D./Principal Investigator, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00195975     History of Changes
Other Study ID Numbers: 00005085
Study First Received: September 14, 2005
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014