Cohort StudiesNCT06861764
The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients
An observational study of Cohort Studies, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cohort Studies
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients (aged ≥ 65 years) who completed the anxiety assessment after the elective noncardiac, non-neurosurgical surgery were included in this study.
Who may be able to join
- elderly patients (age ≥ 65 years)
- non-cardiac surgery, non-neurosurgical surgery
Who cannot join
- History of neurological or psychiatric disorders or use of neuropsychiatric drugs;
- Impaired cognitive function or inability to cooperate with preoperative follow-up;
- Sent to ICU after surgery;
- Deletional delirium outcome;
- Baseline missing >5%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
Read the detailed description
This is a retrospective cohort study using prospective data from a multicenter database. 8000 elderly patients undergoing elective non-cardiac or non-neurosurgical surgery were included in this study. The Generalized Anxiety Disorder Scale (GAD-7) was used to measure preoperative anxiety symptoms. The confusion assessment method (3D-CAM) was used to assess postoperative delirium in elderly patients undergoing non-cardiac surgery. If the patient is discharged, follow up by phone or email. Binary logistic regression analysis and propensity score matching (PSM) and subgroup analysis were used to analyze the data.
- Conditions
- Cohort Studies
- Keywords
- preoperative anxiety, Aged, postoperative delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative anxiety | According to the GAD-7 scale, the population was defined as the Preoperative anxiety group | |
| Non-preoperative anxiety | According to the GAD-7 scale, the population was defined as the Non-preoperative anxiety group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cohort StudiesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861764
- Sponsor's protocol ID
- PLAGH-PA-PD
- Status last verified
- Feb 2025
- First submitted
- 1 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
- ClinicalTrials.gov ID
- NCT06861764
- Acronym / sponsor ID
- PLAGH-PA-PD
- Conditions
- Cohort Studies
- Keywords
- preoperative anxiety, Aged, postoperative delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between Preoperative Anxiety and Postoperative Delirium in Elderly Chinese Patients: a Multicenter Prospective Cohort
Detailed description
This is a retrospective cohort study using prospective data from a multicenter database. 8000 elderly patients undergoing elective non-cardiac or non-neurosurgical surgery were included in this study. The Generalized Anxiety Disorder Scale (GAD-7) was used to measure preoperative anxiety symptoms. The confusion assessment method (3D-CAM) was used to assess postoperative delirium in elderly patients undergoing non-cardiac surgery. If the patient is discharged, follow up by phone or email. Binary logistic regression analysis and propensity score matching (PSM) and subgroup analysis were used to analyze the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative anxiety | – | –According to the GAD-7 scale, the population was defined as the Preoperative anxiety group |
| Non-preoperative anxiety | – | –According to the GAD-7 scale, the population was defined as the Non-preoperative anxiety group |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients (aged ≥ 65 years) who completed the anxiety assessment after the elective noncardiac, non-neurosurgical surgery were included in this study.
Key inclusion criteria (2 listed)
- elderly patients (age ≥ 65 years)
- non-cardiac surgery, non-neurosurgical surgery
Key exclusion criteria (5 listed)
- History of neurological or psychiatric disorders or use of neuropsychiatric drugs;
- Impaired cognitive function or inability to cooperate with preoperative follow-up;
- Sent to ICU after surgery;
- Deletional delirium outcome;
- Baseline missing >5%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative delirium
Time frame: within 7 days after surgery
The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cohort Studies, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.