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

NCT06641986 | Completed

• 1 other identifier: PLAGH-AN-001
• Study Type: observational
• Target: 5,551
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Predictive Model

Keywords

predicted model; major non-cardiac surgery; elderly patients; anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety

  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.

  within 7 days after surgery

Study Arms (1)

Elderly patients

elderly patients undergoing major non-cardiac surgery (aged ≥ 65 years)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (aged ≥ 65 years) who completed the anxiety and depression assessment after the elective major noncardiac, non-neurosurgical surgery were included in this study.

You may qualify if:

• Elderly patients (age ≥ 65 years).
• Undergoing elective surgery with a planned overnight hospital stay following surgery.
• Major non-cardiac surgery, non-neurosurgical surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

First Medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-08

Locations

CN (1)