Clincosm LogoSign in Get a demo

Anxiety Before Non-cardiac Surgery in Adults

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05596188
Collaborator
(none)
424
Enrollment
1
Location
16.7
Anticipated Duration (Months)
25.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    424 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study
    Anticipated Study Start Date :
    Nov 10, 2022
    Anticipated Primary Completion Date :
    Oct 17, 2023
    Anticipated Study Completion Date :
    Mar 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Independent risk factors of preoperative anxiety [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) .

    Secondary Outcome Measures

    1. Incidence of preoperative anxiety [The 1 day before surgery]

      The State anxiety inventory (20-80，lower is better) was used to investigate the incidence of Preoperative anxiety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05596188
    Other Study ID Numbers:
    • SSY04070224
    First Posted:
    Oct 27, 2022
    Last Update Posted:
    Nov 1, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Necrosis

    Study Results

    No Results Posted as of Nov 1, 2022