- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532122
Postoperative Anxiety and Depression Among Chinese Elderly Patients
Prevalence and Risk Factors for Postoperative Anxiety and Depression Symptoms in Non-cardiac Surgery Among Chinese Elderly Patients
The goal of this observational study is to learn about the prevalence of postoperative anxiety and depression symptoms and identify the related risk factors in elderly patients aged 65 and older who undergo non-cardiac surgery in China.
The main questions it aims to answer are:
What is the prevalence rate of postoperative anxiety symptoms in elderly Chinese patients after non-cardiac surgery?
What is the prevalence rate of postoperative depression symptoms in elderly Chinese patients after non-cardiac surgery?
What are the risk and protective factors linked to postoperative anxiety and depression symptoms in this patient population?
Participants will undergo routine non-cardiac surgery as part of their standard medical care, and researchers will collect relevant clinical data and assess their anxiety and depression symptoms using standardized screening scales after surgery.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- First Medical center of Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- elderly patients (age ≥ 65 years)
- undergoing elective surgery with a planned overnight hospital stay following surgery
- non-cardiac surgery, non-neurosurgical surgery
- patients who complete the scale assessment
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: within 7 days after surgery
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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.
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within 7 days after surgery
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Depression
Time Frame: within 7 days after surgery
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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.
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within 7 days after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-Anxiety-Depression
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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