Clinical Trials Directory

Trials / Completed

CompletedNCT01040988

The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study

The ICD/Device Expectations, Adaptations, and Successes (IDEAS) Study: the Relationship Between Implantable Cardioverter-defibrillators, Pacemakers and Psychiatric Symptoms in a Pediatric Population

Status
Completed
Phase
Study type
Observational
Enrollment
166 (actual)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
6 Years – 20 Years
Healthy volunteers
Not accepted

Summary

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).

Conditions

Timeline

Start date
2009-08-01
Primary completion
2010-10-01
Completion
2010-10-01
First posted
2009-12-30
Last updated
2017-04-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01040988. Inclusion in this directory is not an endorsement.