Clinical trial NCT06775223: Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients
Official title: Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Implantable Electronic Devices
Quality of Life
Keywords: quality of life
patient reported outcomes
cardiac implantable electronic devices
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2025-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participant with cardiac implantable electronic devices between the ages of 18-65

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.

Primary outcomes:
measure: Turkish adaptation of the scale assessing quality of life
timeFrame: 1 years
Secondary outcomes:
measure: Evaluation of quality of life
timeFrame: 1 year
measure: Evaluation of quality of life
timeFrame: 1 year
measure: Evaluation of activities of daily living
timeFrame: 1 year
measure: Evaluation of comorbidity level
timeFrame: 1 year
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University Corum Erol Olçok Training and Research Hospital
state: Center
Study officials:
References: