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.