NCT07744295

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

July 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 20, 2026

Last Update Submit

August 1, 2026

Conditions

DepressionAnxietyElderly PatientsNon-cardiac Major Surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    Preoperative (within 3 days before surgery)

  • 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.

    Preoperative (within 3 days before surgery)

Study Arms (1)

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

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (aged ≥65 years) who completed the anxiety and depression assessment before elective non-cardiac major surgery were included in this study

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Chen Cai

CONTACT

+86137187187811607125811@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

July 20, 2026

First Posted

August 4, 2026

Study Start

August 15, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07