NCT06775223 Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients
| NCT ID | NCT06775223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erol Olcok Corum Training and Research Hospital |
| Condition | Cardiac Implantable Electronic Devices |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-06-05 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Having a pacemaker implant and not having any complications at the last pacemaker check-up, * Being in NYHA I-II-III-IV class, * Patients with no cooperation problems, * Volunteering to participate in the study. Exclusion Criteria: * • Patients with insufficient dementia or cognitive impairment due to multiple comorbidities (e.g., recent cerebrovascular accident and/or significant hypotension), * Patients with a history of psychiatric illness, * Patients with speech, hearing or intellectual disabilities.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06775223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cardiac Implantable Electronic Devices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775223 currently recruiting?
Yes, NCT06775223 is actively recruiting participants. Contact the research team at gmzahiskali@gmail.com for enrollment information.
Where is the NCT06775223 trial being conducted?
This trial is being conducted at Çorum, Turkey (Türkiye).
Who is sponsoring the NCT06775223 clinical trial?
NCT06775223 is sponsored by Erol Olcok Corum Training and Research Hospital. The trial plans to enroll 120 participants.