Clinical trial NCT00195975: Heart Rate Variability in Children With a Functional Gastrointestinal Disorder
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Keywords: Abdominal Pain
Functional Gastrointestinal Disorders
Stress
Anxiety
Autonomic Nervous System
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with IBS, FD, or IBS and FD, as well as healthy controls without these conditions.

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.

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 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.

Primary outcomes:
measure: HRV or the magnitude of power in the LF or HF in the fasting or post-prandial state
timeFrame: Same day
measure: HRV or stress profile parameters following an acute stress(mental math)
timeFrame: Same day
measure: Frequency of an abnormal EGG or the magnitude of EGG parameters
timeFrame: Same day
measure: Water load volume
timeFrame: Same day
Secondary outcomes:
measure: Behavioral Assessment System for Children (BASC)
timeFrame: Same day
measure: Salivary cortisol
timeFrame: Same day
measure: A stress profile via the biofeedback equipment (e.g. measures of muscle tension, hand temperature, and skin moisture (conductance).
timeFrame: Same day
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Jennifer V Schurman, PhD
role: PRINCIPAL_INVESTIGATOR
References: