A Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery

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.

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Key information

Conditions

Predictive Model Anxiety Disorders Mental Disorders

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

About this study

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.

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.
Major non-cardiac surgery, non-neurosurgical surgery.

Exclusion criteria

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 ≤ 2.
Failure to complete the postoperative anxiety assessment.

Treatment and study plan

Primary outcomes

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.

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

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 15, 2024
Registry last updated: Oct 15, 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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Completed