Heart Rate Variability in Children With a Functional Gastrointestinal Disorder

Heart Rate Variability in Children With Abdominal Pain Related to a Functional Gastrointestinal Disorder: Relationship to Anxiety/Stress, Electrogastrography, and Rapid Water Loading

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Children with FD
4; Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HRV or the magnitude of power in the LF or HF in the fasting or post-prandial state	Same day
HRV or stress profile parameters following an acute stress(mental math)	Same day
Frequency of an abnormal EGG or the magnitude of EGG parameters	Same day
Water load volume	Same day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (ESTIMATE): September 20, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Abdominal Pain; Autonomic Nervous System; Anxiety; Stress; Functional Gastrointestinal Disorders
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 00005085