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

NCT ID: NCT06775223

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-05

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Implantable Electronic Devices Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac implantable electronic devices

validity and reliability study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role collaborator

Erol Olcok Corum Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gamze Nur AHISKALI

Physiotherapist Gamze Nur AHISKALI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hitit University Corum Erol Olçok Training and Research Hospital

Çorum, Center, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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GAMZE NUR AHISKALI, MsC

Role: CONTACT

+90 551 412 86 87

Facility Contacts

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Gamze N Ahıskalı, master

Role: primary

+905514128687

Other Identifiers

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2024-29

Identifier Type: -

Identifier Source: org_study_id

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