| CTRI Number |
CTRI/2024/03/063970 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
This is a study to understand the role of showing powerpoint comprising of images regarding OT environment and technique of anaesthesia prior to procedure on patient cooperation and satisfaction for spinal anaesthesia |
|
Scientific Title of Study
|
Role of preoperative powerpoint information regarding OT environment and technique of anaesthesia on patient cooperation and satisfaction for spinal anaesthesia |
| 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 Vineet Kumar |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma |
| Address |
Room No 22 second floor
Department of Anaesthesia
Modular OT complex
Pt.B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9416904050 |
| Fax |
|
| Email |
vineetkumar.pgims@uhsr.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Johar |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma |
| Address |
Room No 32 second floor
Department of Anaesthesia
Modular OT complex
Pt.B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9416904050 |
| Fax |
|
| Email |
vntkmr55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vineet Kumar |
| Designation |
Associate Professor |
| Affiliation |
Pt.B.D.Sharma |
| Address |
Room No 22 second floor
Department of Anaesthesia
Modular OT complex
Pt.B.D. Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9416904050 |
| Fax |
|
| Email |
vineetkumar.pgims@uhsr.ac.in |
|
|
Source of Monetary or Material Support
|
| department of anaesthesia
second floor
modular OT complex
Pt.B.D.Sharma PGIMS
Post Graduate Institute of Medical Sciences
Rohtak
Haryana 124001
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Second floor
Modular OT Complex
Pt.B.D.Sharma
Post Graduate Institute of Medical Sciences |
| Type of Sponsor |
Government 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 |
| DrMohd Irfan |
Department of Anaesthesia |
Second Floor
Department of Anaesthesia
Modular OT Complex
Pt.B.D.Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA |
8053734012
irfangobinspur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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 |
control group |
patients undergoing routine preanesthetic checkup one day prior to surgery |
| Intervention |
powerpoint information showing the OT environment and spinal anaesthesia technique |
patients exposed to powerpoint based multimedia information of five minutes during pre anaesthetic checkup one day prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients in the age group 18 to 60 years belonging to ASA I and II posted for orthopaedic surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Prior visit to the operation theatre
Education qualification below metric level
Refusal by patient
Impaired eyesight and hearing
History of psychiatric/neurological disorder
History of head injury
History of drug abuse
History of alcohol abuse
Any psychological trauma in past 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of preoperative powerpoint based information in improving patient’s cooperation and satisfaction for spinal anaesthesia |
Intraoperative baseline and 5 minutes after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Role of preoperative powerpoint based multimedia information in maintenance of hemodynamics & allaying anxiety |
Intraoperative at 5, 10,15, 20, 30, 40 & 50 minutes & 30 minutes post operative period |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
20/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Anticipation of surgical procedures is stressful as the patient is separated from family and friends in an unfamiliar environment depending on strangers. It becomes even more complicated in cases of spinal anaesthesia as the patient is awake and aware of the surroundings. Patient’s cooperation and experience to anaesthesia can be improved by providing explanations , explaining the environment and procedure , enhancing the theatre environment , giving patient an idea of operation theatre to make it less unfamiliar. So, the present study is planned to assess the effect of powerpoint based information on operation theatre environment and technique of spinal anaesthesia in improving patient’s cooperation and satisfaction to spinal anaesthesia in patients undergoing elective surgeries |