Preoperative Anxiety and Depression Amo… | Clinical Trial

Key information

Conditions

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

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

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 significant risk of anxiety and depression in older perioperative patients. However, nationally representative epidemiological data for preoperative anxiety and depression, in particular elderly patients undergoing non-cardiac major surgery, are unavailable in China.

Therefore, providing nationwide epidemiological data on preoperative 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

1. Elderly patients (age ≥65 years) 2. Undergoing elective non-cardiac major surgery with a planned overnight hospital stay following surgery 3. Cognitive ability: Conscious, no severe cognitive impairment (MMSE score ≥24), able to cooperate with scale assessment

Exclusion criteria

1. Patients who refuse to participate in the study 2. Patients with severe dementia, language disorder, severe hearing or visual impairment, or cognitive impairment preventing assessment 3. Patients whose surgeries were canceled 4. History of previous severe mental illness (schizophrenia, bipolar disorder) or long-term use of psychotropic medications 5. Patients admitted to ICU immediately after surgery 6. Patients who did not complete the scale assessment

Treatment and study plan

Primary outcomes

Preoperative Anxiety

Time frame: Preoperative (within 3 days before 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 ≥5, corresponding with at least a mild level of anxiety. Higher scores mean more anxiety.
Preoperative Depression

Time frame: Preoperative (within 3 days before surgery)

Depression was assessed using the 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 ≥5, corresponding with at least a mild level of depression. The higher the score, the worse the situation. Higher scores indicate more depressive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Cai

CONTACT

[email protected]

+8613718718781

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

Preoperative Anxiety and Depression Among Older Chinese Patients: A Multicenter Cross-sectional Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 4, 2026
Registry last updated: Aug 4, 2026

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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Completed