A Prediction Model of Postoperative Anxiety Symptom in El... | NCT06641986

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

NCT06641986

Sponsor

Chinese PLA General Hospital

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

5,551Actual

Phase

Not provided

Conditions

Predictive Model

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Oct 13, 2024

First Submission Date that Met QC Criteria

Oct 13, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2024

Last Update Posted Date

Oct 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weidong Mi, Director (Cheif expert of National key research and development program of China 2018YFC2001900), Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Name	Class
Beijing Tiantan Hospital	OTHER
Peking University First Hospital	OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Previous studies have found high risk of anxiety in older perioperative patients, especially for non-cardiac major surgery patients. Therefore, it is necessary to construct a predictive model of anxiety in elderly patients undergoing non-cardiac major surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,551Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly patients		elderly patients undergoing major non-cardiac surgery (aged ≥ 65 years)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Medical center of Chinese PLA General Hospital		Beijing	Beijing Municipality	China	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided