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临床试验/NCT07633483
NCT07633483已完成不适用

Assessment of the Relationship Between Preoperative Anxiety Level Measured by the Hamilton Anxiety Rating Scale and Frailty Score Assessed by the FRAIL Scale in Elderly Patients Aged 65 Years and Older Scheduled for Elective Hip Arthroplasty: A Prospective Observational Single-Center Study

Başakşehir Çam & Sakura City Hospital2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
2

研究概览

简要总结

Frailty is a state of vulnerability resulting from decreased physiological reserve across multiple organ systems, impairing an individual's ability to withstand stressors. As the elderly population grows worldwide, the proportion of older adults undergoing surgical procedures continues to rise, and frailty is expected to become increasingly prevalent among surgical candidates.

Anxiety is one of the most common psychiatric conditions, affecting approximately one in three individuals globally. Preoperative anxiety may negatively influence surgical outcomes, particularly in older and more vulnerable patients.

This prospective observational study aims to evaluate the relationship between preoperative anxiety level and frailty score in elderly patients aged 65 years and older scheduled for elective hip arthroplasty. Frailty will be assessed using the FRAIL Scale (Fatigue, Resistance, Ambulation, Illness, Loss of Weight), and anxiety will be measured using the Hamilton Anxiety Rating Scale (HAM-A). Secondary outcomes include the prevalence of frailty and anxiety, the effect of frailty on length of hospital stay, postoperative intensive care unit admission rates, and the relationship between frailty and preoperative laboratory and hemodynamic parameters.

详细描述

Background:

The population aged 65 years and older is growing rapidly worldwide. In Turkey, this demographic increased by 21.4% between 2018 and 2023, reaching over 8.7 million individuals, and is projected to constitute 25.6% of the total population by 2080. Parallel to this trend, the number of elderly patients undergoing surgical procedures is rising, and frailty is expected to become increasingly common among surgical candidates.

Frailty is defined as a state of vulnerability arising from decreased physiological reserve and function across multiple organ systems. The FRAIL Scale, developed by Morley et al. in 2012, is a validated five-item tool assessing Fatigue, Resistance, Ambulation, Illness, and Loss of Weight. Each item is scored 0 or 1, yielding a total score of 0-5. Patients scoring 0 are classified as robust, those scoring 1-2 as pre-frail, and those scoring 3-5 as frail. The Turkish validity and reliability of the FRAIL Scale was established in 2017 at Hacettepe University Faculty of Medicine.

Anxiety is among the most prevalent psychiatric conditions globally. The Hamilton Anxiety Rating Scale (HAM-A), developed in 1959, is a widely used clinician-administered instrument for assessing anxiety severity, consisting of 14 items with a total score range of 0-56.

While the association between frailty and depression has been explored in the literature, studies specifically examining the relationship between frailty and preoperative anxiety remain limited. A 2023 systematic review identified a need for further research on this topic.

研究设计

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

入排标准

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

入选标准

  • Patients of both sexes aged 65 years and older
  • Patients with ASA physical status classification I, II, or III scheduled for elective hip arthroplasty
  • Patients who voluntarily agree to participate in the study
  • Patients with intact orientation and sufficient cooperation for assessment

排除标准

  • Patients with ASA physical status classification IV or V
  • Patients who refuse to participate in the study
  • Patients with impaired orientation or insufficient cooperation for assessment
  • Patients scheduled for emergency surgery
  • Patients to be operated during an active intensive care unit admission

研究组 & 干预措施

Robust

Participants with a FRAIL Scale score of 0, indicating no signs of frailty.

Pre-Frail

Participants with a FRAIL Scale score of 1-2, indicating early signs of frailty.

Frail

Participants with a FRAIL Scale score of 3-5, meeting the criteria for frailty.

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muzaffer GENCER

Associate Professor Doctor

Başakşehir Çam & Sakura City Hospital

研究点 (2)

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