跳至主要内容
临床试验/NCT06495840
NCT06495840撤回不适用

Postoperative Anxiety and Depression Among Older Chinese Patients: A Prospective Observational Study Based on a Multi-center Perioperative Database in China

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 8,525 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
撤回
发起方
入组人数
8,525
试验地点
1
主要终点
Depression

研究概览

简要总结

A multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the Chinese old population.

详细描述

As China's population ages, the proportion of elderly people undergoing surgery increases. Perioperative anxiety and depression, particularly in elderly patients, is common and associated with multiple medical and social adversities. Previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. However, nationally representative epidemiological data for postoperative anxiety and depression, in particular elderly patients undergoing non-cardiac surgery, are unavailable in China. Therefore, providing nationwide epidemiological data on postoperative anxiety and depression in Chinese elderly patients provides a valuable opportunity for policy makers and health care professionals to optimize the management of geriatric mental health in China.

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

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

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
  • patients who did not complete the scale assessment

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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