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Completed

NCT Number: NCT06495840

Postoperative Anxiety and Depression Among Older Chinese Patients

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Elderly Patients Mental Disorders Non-cardiac Surgery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Medical center of Chinese PLA General Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Tiantan Hospital
  • Central South University
  • China-Japan Friendship Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Fudan University
  • Peking University First Hospital
  • Peking University People's Hospital
  • Shanghai Zhongshan Hospital
  • Sun Yat-sen University
  • Taihe Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital of Central South University
  • Zhejiang Provincial People's Hospital
  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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