| CTRI Number |
CTRI/2025/11/097235 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on what patients know and worry about anesthesia before their surgery. |
|
Scientific Title of Study
|
Assessment of knowledge and concerns of patients regarding anesthesia during preoperative evaluation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveena Pandiyan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena Pandiyan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raut Akshada Sonba |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9082543367 |
| Fax |
|
| Email |
akshadaraut1311@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636308 |
| Type of Sponsor |
Private medical college |
|
|
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 Raut Akshada Sonba |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
Pre anaesthetic evaluation room, Department of Anaesthesiology, Room number 14
Salem
TAMIL NADU |
9082543367
akshadaraut1311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgery under general anesthesia, regional anesthesia or nerve blocks.
2. Age group: 18 to 70 years
3. Both male and female patients
4. Patient providing written informed consent
5. Obstetric patients |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18 and more than 70 years
3. Patients with known psychiatric illness
4. Patients with head trauma, GCS less than 13
5. History of delirium and/or confusion
6. Pediatric patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the patient’s knowledge about anesthesia and assess the concerns and anxiety related to anesthesia with a standardized questionnaire during preoperative evaluation. |
Data recorded during anesthesic evaluation before surgery - Typically 1-2 days before surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
24/11/2025 |
| 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="1"
Months="0"
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 is a cross-sectional observational
study designed to assess the knowledge and concerns of patients regarding
anesthesia during preoperative evaluation.
A total of 150 adult patients (aged 18–70
years, ASA I–III) undergoing elective surgeries under general anesthesia,
regional anesthesia, or nerve blocks will be enrolled after obtaining informed
consent. Each participant will complete a standardized 40-question
questionnaire, available in English and Tamil, administered through a personal
interview.
The primary objective is to evaluate
patients’ understanding of anesthesia and the role of anesthesiologists.
The secondary objective is to assess their
concerns and anxiety related to anesthesia using a structured scoring system to
categorize levels of awareness and anxiety.
The study aims to identify gaps in patient
knowledge and common concerns about anesthesia, thereby helping to improve
preoperative counseling and patient confidence before surgery.
|