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临床试验/NCT07532122
NCT07532122已完成不适用

Prevalence and Risk Factors for Postoperative Anxiety and Depression Symptoms in Non-cardiac Surgery Among Chinese Elderly Patients

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 8,590 人开始时间: 2020年1月1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
8,590
试验地点
1
主要终点
Depression

研究概览

简要总结

The goal of this observational study is to learn about the prevalence of postoperative anxiety and depression symptoms and identify the related risk factors in elderly patients aged 65 and older who undergo non-cardiac surgery in China.

The main questions it aims to answer are:

What is the prevalence rate of postoperative anxiety symptoms in elderly Chinese patients after non-cardiac surgery?

What is the prevalence rate of postoperative depression symptoms in elderly Chinese patients after non-cardiac surgery?

What are the risk and protective factors linked to postoperative anxiety and depression symptoms in this patient population?

Participants will undergo routine non-cardiac surgery as part of their standard medical care, and researchers will collect relevant clinical data and assess their anxiety and depression symptoms using standardized screening scales after surgery.

详细描述

This is a multicenter, retrospective observational study conducted across 19 medical centers in China, enrolling a total of 8590 elderly patients aged 65 years and above who received non-cardiac surgery between April 1, 2020, and April 30, 2022. The study was designed to fill the gap of lacking comprehensive epidemiological data on postoperative mental health disorders in this specific patient group in China, focusing on postoperative anxiety and depression symptoms that are tied to various adverse medical and social outcomes.

研究设计

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

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

  • elderly patients (age ≥ 65 years)
  • undergoing elective surgery with a planned overnight hospital stay following surgery
  • non-cardiac surgery, non-neurosurgical surgery
  • patients who complete the scale assessment

排除标准

  • patients fully refused to participate in the study
  • patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status
  • patients whose surgeries were canceled
  • history of previous severe mental illness or long-term use of psychotropic medications
  • patients admitted to ICU immediately after surgery
  • patients who died within 7 days after surgery

结局指标

主要结局

Depression

时间窗: within 7 days after surgery

Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe level of depression. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms.

Anxiety

时间窗: within 7 days after surgery

The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe anxiety. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

研究点 (1)

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