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Clinical Trials/NCT06775223
NCT06775223CompletedNot Applicable

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

Erol Olcok Corum Training and Research Hospital1 site in 1 country120 target enrollmentStarted: June 5, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Turkish adaptation of the scale assessing quality of life

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Turkish adaptation of the scale assessing quality of life

Time Frame: 1 years

The Assessment of Quality of Life And RELated Events (AQUAREL) scale, which was created especially for people with cardiac implanted electronic devices, will be translated into Turkish. / The total score ranges from 0 to 100. A low score reflects poor health perception, loss of function and presence of pain, while a high score reflects good health perception, preserved function and absence of pain.

Secondary Outcomes

  • Evaluation of quality of life(1 year)
  • Evaluation of activities of daily living(1 year)
  • Evaluation of comorbidity level(1 year)

Investigators

Sponsor
Erol Olcok Corum Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gamze Nur AHISKALI

Physiotherapist Gamze Nur AHISKALI

Erol Olcok Corum Training and Research Hospital

Study Sites (1)

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