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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
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The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. In the case of patients with ICDs, these devices are programmed to deliver a strong electrical shocks. In adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. Very few studies have looked at this question in children. We propose to evaluate a cohort of patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (PTSD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker | Patients meeting entry criteria with a pacemaker in place. | ||
| ICD | Patients meeting entry criteria with an ICD in place. |
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| Measure | Description | Time Frame |
|---|---|---|
| To compare the prevalence of depressive and anxiety disorders (including PTSD) in patients with ICDs or pacemakers using a semi-structured psychiatric interview. | One-time measure at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| We will compare scores on standardized self-assessment tools for subsets of depression and anxiety (including PTSD). | One-time at enrollment | |
| We will compare health-related quality of life between pediatric patients with an ICD and those with a pacemaker. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Webster, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14996583 | Background | DeMaso DR, Lauretti A, Spieth L, van der Feen JR, Jay KS, Gauvreau K, Walsh EP, Berul CI. Psychosocial factors and quality of life in children and adolescents with implantable cardioverter-defibrillators. Am J Cardiol. 2004 Mar 1;93(5):582-7. doi: 10.1016/j.amjcard.2003.11.022. | |
| 24664095 | Derived | Webster G, Panek KA, Labella M, Taylor GA, Gauvreau K, Cecchin F, Martuscello M, Walsh EP, Berul CI, DeMaso DR. Psychiatric functioning and quality of life in young patients with cardiac rhythm devices. Pediatrics. 2014 Apr;133(4):e964-72. doi: 10.1542/peds.2013-1394. Epub 2014 Mar 24. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| One-time at enrollment |
| We will examine caregiver adjustment and family functioning in families of patients with ICDs versus families of patients with pacemakers. | One-time at enrollement |
| We intend to gather descriptive data on how patients in this age group view their devices. | One-time at enrollment |
| D000068099 |
| Trauma and Stressor Related Disorders |