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临床试验/NCT06641986
NCT06641986已完成不适用

Identification and Validation of a Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery: a Prospective Multicenter Cohort Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 5,551 人开始时间: 2020年4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
5,551
试验地点
1
主要终点
Anxiety

研究概览

简要总结

A multicentre, prospective observational study to develop and validate a predictive model for postoperative anxiety symptoms in elderly Chinese patients undergoing non-cardiac major surgery.

详细描述

In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Previous studies have found high risk of anxiety in older perioperative patients, especially for non-cardiac major surgery patients. Therefore, it is necessary to construct a predictive model of anxiety in elderly patients undergoing non-cardiac major surgery.

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 100 Years(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.
  • Major non-cardiac surgery, non-neurosurgical surgery.

排除标准

  • History of previous severe mental illness or long-term use of psychotropic medications.
  • Immediately admitted to ICU after surgery.
  • Death within 7 days after surgery.
  • Grade of surgery ≤
  • Failure to complete the postoperative anxiety assessment.

结局指标

主要结局

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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