Understanding Pediatric Chest Pain and Other Symptoms
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|ClinicalTrials.gov Identifier: NCT00166231|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 25, 2015
The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress.
This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups.
The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.
|Condition or disease|
The current investigation will address some similar factors considered in prior research, but will considerably extend our understanding of how psychological, familial, and environmental factors influence noncardiac chest pain. In this investigation, a number of variables that have not been considered in prior research in this area will be included. Among these child variables are: the children's pain coping strategies, the children's somatization behaviors aside from chest pain, the children's externalizing symptoms (e.g., symptoms of ADHD, oppositional defiant disorder), school related problems, social competencies, parental perceptions of the child's vulnerability, functional disability (the degree to which chest pain interferes with normal daily functioning), and the child's health care utilization. Also, a more sensitive quantification of the children's frequency and intensity of chest pain will be collected, as well as information on situations in which the pain occurs. Parent report of child functioning and child self-report will be used to assess children's behavior. The parental factors to be assessed include the parents' own physical conditions and health care utilization, as well as the parents' psychological functioning. The amount of changes and stress the family as a whole has experienced in different domains will also be assessed as well. Measures of these constructs, as well as children's anxiety and depression (similar to Lipsitz et al. reviewed above) will be collected at the time of the original appointment.
With the exception of the chest pain measure, quantification of these variables will be collected for both chest pain and innocent murmur patients between the ages of 8 and 18 years of age at the time of their initial appointment. Further, approximately one month following the medical assessment by the cardiologists, the parents and children will be asked to complete a measure of their satisfaction with the medical care they were provided, their health care utilization subsequent to the diagnostic cardiology appointment, their various somatic symptoms, and their functional disability at the one month follow-up assessment. Also, the chest pain patients will be asked to complete the chest pain inventory in conjunction with their parent.
Between-group analyses will address how these multiple variables differ for the chest pain group and patients presenting for an evaluation for heart murmurs. This will be true at both the time of the patients' appointment and at follow-up. Further, within-group correlational analyses will be conducted primarily for with the chest pain group. The goal of these within group analyses will be to address how the various child, parent, and familial factors correlate with the children's chest pain symptoms, healthcare utilization, other somatic symptoms, and functional disability. In addition, for the chest pain group, the patients' and their families' functioning at the time of the initial appointment will be used to predict chest pain and other somatic symptom maintenance, health care utilization following the initial appointment, and satisfaction with their medical care at follow-up. Each of these questions will advance the literature in this area.
We should also point out why the innocent murmur group was chosen as a comparison sample for the chest pain patients. As noted above, pain is a subjective experience that is first noted by the patient and then communicated to others. It is then reacted to in various ways by those in the child's environment. In contrast, a child with a heart murmur is not the one who first notices the symptom and then communicates it. Instead, the patient with a murmur is told that they have the symptom by a pediatrician, family practice physician, or other health care provider. This tendency to notice and interpret pain in a particular manner is an essential component in the history of the children and their families who report to cardiology clinics for an evaluation of the etiology of chest pain. Such noticing and interpretation is fundamentally a psychological process.
Comparison: adolescents who present in a cardiac specialty clinic with noncardiac chest pain versus those who present with innocent murmurs.
|Study Type :||Observational|
|Actual Enrollment :||156 participants|
|Official Title:||Understanding Pediatric Symptoms and Other Symptoms|
|Study Start Date :||March 2004|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
|Chest pain patients|
- Change in Children Depression Inventory [ Time Frame: Baseline, 4 weeks ]Children Depression Inventory (CDI) is a 27-item self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.
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 ClinicalTrials.gov identifier (NCT number): NCT00166231
|United States, Georgia|
|Childrens Healthcare of Atlanta at Egleston|
|Atlanta, Georgia, United States, 30322|
|Sibley Heart Center Cardiology|
|Atlanta, Georgia, United States, 30341|
|Principal Investigator:||Robert M Campbell, MD||Emory University|
|Principal Investigator:||Ronald L. Blount, PhD||University of Georgia|
|Principal Investigator:||Greg Johnson, MD||Emory University|
|Principal Investigator:||Rose Cummings, DO||Emory University|
|Principal Investigator:||Patty Simpson, MSN||Emory University|
|Principal Investigator:||Kenneth Dooley, MD||Emory University|