| CTRI Number |
CTRI/2025/12/098619 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the anxiety level of the patients posted for surgery and to see whether the anxiety levels will decrease after educating them with anaesthesia related video or anaesthesia information sheet |
|
Scientific Title of Study
|
Effects Of Informational Video And Anaesthesia Information Sheet On Preoperative Anxiety In Patients Posted For Elective Laproscopic Surgeries : A Randomised Control Study |
| 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 Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical college Hospital |
| Address |
Department of Anaesthesia Rajarajeswari Medical College and hospital Kambipura mysore road
Bangalore
KARNATAKA
560074
India |
| Phone |
9740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical college Hospital |
| Address |
Department of Anaesthesia Rajarajeswari Medical College and hospital Kambipura mysore road
Bangalore
KARNATAKA
560074
India |
| Phone |
9740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya C R |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical college Hospital |
| Address |
Department of Anaesthesia Rajarajeswari Medical College and hospital Kambipura mysore road
Bangalore
KARNATAKA
560074
India |
| Phone |
9740060543 |
| Fax |
|
| Email |
crnavya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital kambipura mysore road 560074 |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari medical college hospital |
| Address |
Rajarajeswari medical college and hospital kambipura mysore road 560074 |
| 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 NAVYA C R |
Rajarajeswari medical college hospital |
Dpaerment of anaesthesia Rajarajeswari medical college and hospital kambipura mysore 560074 road 560074
Bangalore
KARNATAKA |
9740060543
crnavya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
ANAESTHESIA INFORMATION SHEET |
Anaesthesia information sheet explain how surgery is done under anaesthesia |
| Intervention |
INFORMATIONAL VIDEO |
Video is created about patient undergoing laproscopic surgery under anaesthesia in patients own language |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age group of 18-60 yrs
Patient with ASA status 1,2
Patients undergoing elective laparoscopic surgeries
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of anesthesia education through video and information sheet in reducing the preoperative anxiety. |
Before the day of surgery and on the day of surgery before shifting to OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare a) the incidence of PONV b) VAS score postoperatively c) requirement of additional analgesics.
|
during post surgery in post operative ward during 1 hour & after 6 hours |
|
|
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)
|
20/12/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Our study is about assessing the preoperative anxiety in patients posted for elective laproscopic surgery using informational video and anaesthesia information sheet for which institutional ethical committee approval has been taken |