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

E

Erol Olcok Corum Training and Research Hospital

Status

Enrolling

Conditions

Quality of Life
Cardiac Implantable Electronic Devices

Treatments

Other: Cardiac implantable electronic devices

Study type

Observational

Funder types

Other

Identifiers

NCT06775223
2024-29

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

GAMZE NUR AHISKALI, MsC

Data sourced from clinicaltrials.gov

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