Anxiety Before Non-cardiac Surgery in Adults

May 29, 2023 updated by: RenJi Hospital

Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study

Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

424

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • RenJi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who met the eligibilty criteria for elective surgery under general anesthesia.

Description

Inclusion Criteria:

  1. patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
  2. The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;

4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.

Exclusion Criteria:

  1. Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
  2. Patients with serious diseases of heart, liver, lung, kidney or other organs.
  3. Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
  4. Those who use sedatives before evaluation in this study;
  5. Drug addicts;
  6. Alcoholics;
  7. pregnant women;
  8. participated in other clinical trials as a subject in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent risk factors of preoperative anxiety and establishment of prediction model
Time Frame: From the 1 day before surgery to 7 days after surgery or discharge, whichever came first
To identify the independent factors related to preoperative anxiety, which would be analyzed by Logistic regression according to anxiety or not before surgery evaluated by the State anxiety inventory（20-80，lower is better) . Meanwhile, the prediction model of preoperative anxiety would be established based on independent factors.
From the 1 day before surgery to 7 days after surgery or discharge, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of preoperative anxiety
Time Frame: The 1 day before surgery
The State anxiety inventory (20-80，lower is better) was used to investigate the incidence of Preoperative anxiety
The 1 day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Estimated)

October 17, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSY04070224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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