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Clinical Trials/NCT06495840
NCT06495840
Completed
Not Applicable

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 site in 1 country8,525 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Chinese PLA General Hospital
Enrollment
8525
Locations
1
Primary Endpoint
Depression
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 30, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Weidong Mi

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

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
  • ASA grade ≥ 4
  • patients admitted to ICU immediately after surgery
  • patients who died within 7 days after surgery
  • patients who did not complete the scale assessment

Outcomes

Primary Outcomes

Depression

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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