Anxiety Before Non-cardiac Surgery in Adults

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596188
• Other study ID #: SSY04070224
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Min Chen
• Phone: +862168383702
• Email: chenmin[@]renji.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 and prediction model would be established.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: March 31, 2024
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Femoral Head Necrosis
• Gastric Carcinoma
• Myoma of Uterus
• Necrosis
• Prostate Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independent risk factors of preoperative anxiety and establishment of prediction model	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	Incidence of preoperative anxiety	The State anxiety inventory (20-80,lower is better) was used to investigate the incidence of Preoperative anxiety	The 1 day before surgery