| CTRI Number |
CTRI/2026/01/101795 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Patient Understanding and Comfort Before Surgery Through Better Anaesthesia Communication |
|
Scientific Title of Study
|
Effectiveness of structured preoperative anaesthesia communication on patient understanding and emotional comfort in surgical patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Sharukh |
| Designation |
Pg Scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-26,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
8125522536 |
| Fax |
|
| Email |
Sharukhbasha786786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Gayathri |
| Designation |
Professor & Hod |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-24,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrb@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shaik Sharukh |
| Designation |
Pg Scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No D4-26,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU
603203
India |
| Phone |
8125522536 |
| Fax |
|
| Email |
Sharukhbasha786786@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology, SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 B Gayathri |
SRM Medical college hospital |
Room No D4-24,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU |
9500092905
gayathrb@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z718||Other specified counseling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 and 60 years.
2.patient scheduled for elective procedure under anaesthesia.
3.Patients with ASA I, II & III |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patients with psychotic disorder.
3.Patient with decreased cognitive function or psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in patient understanding and emotional comfort related to anaesthesia following structured preoperative anaesthesia communication, assessed using the Pre Anaesthesia Communication Assessment Tool (CAT) during the pre anaesthesia check up. |
Time Point 1 (Baseline T0):
During pre-anaesthesia check-up, before structured preoperative anaesthesia communication (Day 1 or day of PAC).Time Point 2 (Post-intervention T1):Immediately after structured preoperative anaesthesia communication during the same pre-anaesthesia check-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="182"
Sample Size from India="182"
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)
|
02/02/2026 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sharukhbasha786786@gmail.com].
- For how long will this data be available start date provided 09-10-2026 and end date provided 09-10-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of structured preoperative anaesthesia communication on patient understanding and emotional comfort among adult surgical patients. Adult patients aged 18–60 years scheduled for elective surgery under anaesthesia and classified as ASA physical status I–III will be included. During the pre-anaesthesia check-up, patients will receive structured communication regarding the type of anaesthesia, procedure, risks, and perioperative care. Patient understanding, emotional comfort, and anxiety levels will be assessed using validated questionnaires before and immediately after the communication. The study seeks to determine whether structured preoperative anaesthesia communication improves patient comprehension and reduces emotional distress prior to surgery |