Preoperative Anxiety and Depression Among Older Chinese Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-100
SponsorChinese PLA General Hospital
About this trial
A multicenter, cross-sectional study to characterize the clinical profiles of the Chinese elderly population and to determine the prevalence of preoperative anxiety and depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Elderly patients (aged ≥65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
8,000 Participants
are grouped into 1 trial groupGroup A: Elderly patients undergoing non-cardiac major surgery (aged ≥65 years)
Trial outcomes
Primary outcomes
1
Preoperative 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 ≥5, corresponding with at least a mild level of anxiety. Higher scores mean more anxiety.
Time frame
Preoperative (within 3 days before surgery)2
Preoperative Depression
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.
Time frame
Preoperative (within 3 days before surgery)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
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
Source ClinicalTrials.gov
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