Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06775223

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, 19000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gamze N Ahıskalı, master

CONTACT

[email protected]

+905514128687

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac implantable electronic devices

Other

validity and reliability study

Primary outcomes

  1. 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

  1. Evaluation of quality of life

    Time frame: 1 year

    Short Form- 36 -SF-36 Life Questionnaire / Each sub-parameter is scored between 0 and 100. A high score indicates that the individual has a high quality of life.

  2. Evaluation of quality of life

    Time frame: 1 year

    MacNew Heart Disease Health-Related Quality of Life Questionnaire / The questions are scored from 1 to 7, with higher scores indicating better quality of life.

  3. Evaluation of activities of daily living

    Time frame: 1 year

    Performance Measure for Activities of Daily Living-8 for Patient with Mild Symptomatic Heart Failure- PMADL-8 / The total score ranges from 8-32, with a high score indicating a level of limitation in activities of daily living.

  4. Evaluation of comorbidity level

    Time frame: 1 year

    Modified Charlson Comorbidity İndex (CCI) / Comorbidity classification is low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7) and very high comorbidity (score ≥ 8). High score indicates high mortality rates.

Study contacts

Contact information is provided by the study sponsor or research team.

GAMZE NUR AHISKALI, MsC

CONTACT

[email protected]

+90 551 412 86 87

Sponsors and collaborators

Lead sponsor

Erol Olcok Corum Training and Research Hospital

Other

Collaborators

  • Hacettepe University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.