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临床试验/NCT06775223
NCT06775223已完成不适用

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 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Turkish adaptation of the scale assessing quality of life

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •• 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.

结局指标

主要结局

Turkish adaptation of the scale assessing quality of life

时间窗: 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.

次要结局

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

研究者

发起方
Erol Olcok Corum Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Nur AHISKALI

Physiotherapist Gamze Nur AHISKALI

Erol Olcok Corum Training and Research Hospital

研究点 (1)

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