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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorErol Olcok Corum Training and Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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 population

participant with cardiac implantable electronic devices between the ages of 18-65

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac implantable electronic devices

    Other intervention

    validity and reliability study

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Turkish adaptation of the scale assessing quality of life

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.

Time frame
1 years

Secondary outcomes

1

Evaluation of quality of life

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.

Time frame
1 year
2

Evaluation of quality of life

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.

Time frame
1 year
3

Evaluation of activities of daily living

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.

Time frame
1 year
4

Evaluation of comorbidity level

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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