Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166231
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2005-09-13
Brief Title:
Understanding Pediatric Chest Pain and Other Symptoms
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Understanding Pediatric Symptoms and Other Symptoms
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs distress
This early study will ask parents and children specific questions related to the stress in their lives their emotional well-being and the childrens 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
This early study will ask parents and children specific questions related to the stress in their lives their emotional well-being and the childrens 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
Detailed Description:
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 childrens pain coping strategies the childrens somatization behaviors aside from chest pain the childrens externalizing symptoms eg symptoms of ADHD oppositional defiant disorder school related problems social competencies parental perceptions of the childs vulnerability functional disability the degree to which chest pain interferes with normal daily functioning and the childs health care utilization Also a more sensitive quantification of the childrens 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 childrens 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 childrens 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 childrens 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 childs 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
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 childrens 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None