Clinical Trial

Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients

Completed
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Summary
Cardiac implantable electronic devices are widely utilized to lower the rates of morbidity and mortality from ventricular tachycardia and ventricular fibrillation, as well as the incidence of sudden cardiac death. Although implantation of these devices increases survival rates, patients may experience acute and chronic complications. These complications include device dislocation and fracture, inappropriate shocks, pocket hematoma, or infection. Furthermore, functional loss in the upper extremity may result from upper extremity restrictions that are applied for an excessively long time in order to ensure proper placement of the device following implantation, or from patients who choose to extend this period on their own initiative out of worry about device failure or dislocation. Patients' quality of life may be negatively impacted by these issues as well as diminished exercise capacity, weariness, and weaker respiratory and peripheral muscles. A quality of life scale called 'The Assessment of Quality of Life and Related Events (AQUAREL)' was developed by Stoffmel et al. for patients using pacemakers. In this study, the validity and reliability study of the Turkish version of the AQAREL Scale will be conducted.
Protocol Amendment History 1 change
critical Trial completed 2026-07-30
Trial Details
NCT Number NCT06775223
Lead Sponsor Erol Olcok Corum Training and Research Hospital
Collaborators: Hacettepe University
Conditions Cardiac Implantable Electronic Devices, Quality of Life
Enrollment 120 participants
Start Date 2024-06-05
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-29