| CTRI Number |
CTRI/2025/08/092218 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out how much patients know about anesthesia and anesthesiologists and how this affects their anxiety before surgery. |
|
Scientific Title of Study
|
Prevalence of preoperative anxiety and its correlation with knowledge about
anaesthesia in patients undergoing elective surgery at a Tertiary care centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J JASMINE EZHIL |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology program,
5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9150218137 |
| Fax |
|
| Email |
jasmine.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Satish |
| Designation |
Assistant professor and guide |
| Affiliation |
Kasturba Medical College and Hospital, Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology, Kasturba Hospital, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8848998980 |
| Fax |
|
| Email |
aparnasshenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
J JASMINE EZHIL |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Anaesthesia and Operation Theatre Technology program, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9150218137 |
| Fax |
|
| Email |
jasmine.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Medical college, Manipal, Udupi Karnataka. 576104 |
|
|
Primary Sponsor
|
| Name |
Jasmine Ezhil J |
| Address |
Anaesthesia and Operation Theatre Technology program, 5th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka,576104. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna Satish |
Kasturba Hospital and medical college |
surgical ward, 2nd floor, main OT block, Manipal, 576104
Udupi
KARNATAKA |
8848998980
aparna.satish@maipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital Institutional Ethics committee -2 (student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants undergoing all elective surgery
Participants with functional speech and hearing |
|
| ExclusionCriteria |
| Details |
Participants with Cognitive impairment
Participants undergoing Emergency surgery
Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine prevalence of anxiety prior to surgery in patients undergoing elective surgery in tertiary
care center |
On the day before elective surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between the level of preoperative anxiety and the knowledge about
anaesthesia in the patients undergoing elective surgery in tertiary care Centre |
On the day before elective surgery |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This was an Observational cross-sectional study conducted to find the Prevalence of preoperative anxiety and its correlation with knowledge about
anaesthesia in patients undergoing elective surgery at a Tertiary care centre . The primary objective is to determine the prevalence of anxiety prior to surgery in patients undergoing elective surgery in a tertiary
care center. The secondary objective is to evaluate the correlation between the level of preoperative anxiety and the knowledge about
anaesthesia in the patients undergoing elective surgery in the tertiary care Centre |