Understanding Pediatric Chest Pain and Other Symptoms
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||December 11, 2013|
|Start Date ICMJE||March 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00166231 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Understanding Pediatric Chest Pain and Other Symptoms|
|Official Title ICMJE||Understanding Pediatric Symptoms and Other Symptoms|
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
enrolling pediatric patients with either chest pain or innocent heart murmor referals
|Condition ICMJE||Chest Pain|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||120|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||8 Years to 18 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00166231|
|Other Study ID Numbers ICMJE||IRB00021881|
|Has Data Monitoring Committee||No|
|Responsible Party||Robert Campbell, MD, Emory University|
|Study Sponsor ICMJE||Emory University|
|Information Provided By||Emory University|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP