| CTRI Number |
CTRI/2024/03/064099 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of awareness among patients about anaesthesia and the anaesthesiologist in a tertiary hospital in Kolkata. |
|
Scientific Title of Study
|
A Study of Patient’s Knowledge and Perception about Anaesthesia and Anaesthesiologist in a Tertiary Care Hospital in Kolkata. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjan Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
I.P.G.M.E.R. and S.S.K.M. Hospital Kolkata. |
| Address |
16A Lake View Road Kolkata 700029.
Department of Anaesthesiology and Intensive Care.
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital. 244, AJC Bose Road, Kolkata 700020.
Kolkata
WEST BENGAL
700029
India |
| Phone |
9831257338 |
| Fax |
2223-5181 |
| Email |
anjan.chat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjan Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
I.P.G.M.E.R. and S.S.K.M. Hospital Kolkata. |
| Address |
16A Lake View Roag Kolkata 700029
Department of Anaesthesiology and Intensive care.
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
244, AJC Bose Road, Kolkata 700020.
Kolkata
WEST BENGAL
700029
India |
| Phone |
9831257338 |
| Fax |
2223-5181 |
| Email |
anjan.chat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjan Chattopadhyay |
| Designation |
Assistant Professor |
| Affiliation |
I.P.G.M.E.R. and S.S.K.M. Hospital Kolkata. |
| Address |
16A Lake View Roag Kolkata 700029
Department of Anaesthesiology and Intensive care.
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
244, AJC Bose Road, KOlkata 700020.
Kolkata
WEST BENGAL
700029
India |
| Phone |
9831257338 |
| Fax |
2223-5181 |
| Email |
anjan.chat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
I.P.G.M.E.R. and S.S.K.M. Hospital Kolkata.
244, AJC Bose Road, Kolkata pin-700020.
under Department of Health and Family Welfare,
Government of West Bengal.
As a part of routine patient care. No extra funding for this study. |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
244, AJC Bose Road, KOlkata 700020.
under Department of Health and Family Welfare. Government of West Bengal.
As a part of routine patient care. No extra funding for this study |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| No 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 Anjan Chattopadhyay |
I.P.G.M.E.R. and S.S.K.M. Hospital Kolkata |
Department of Anaesthesiology and Intensive care.
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
244, AJC Bose Road, Kolkata 700020.
Kolkata
WEST BENGAL |
9831257338
2223-5181
anjan.chat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight 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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18 to 75 years who visit the preanesthesia check up clinics of IPGME&R and are planned to undergo some surgery under anaesthesia and who give written informed consent. |
|
| ExclusionCriteria |
| Details |
Paediatric patients, Elderly beyond 75 years of age, psychiatric illness intellectual disabilities and those who do not give consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge score of patients, on their perception of anaesthesia and the anaesthesiologist. It is based on a questionnaire , where Q1 to 5 is demographic information , Q 6 to 20 carries 1 mark each, a dichotomous scale is used as "good " or "poor" knowledge score based on a score of 7 or more and a score of less than 7 respectively. |
To assess the knowledge score of patients attending the preanaesthesia check up OPDs about anaesthesia and the anaesthesiologist 1 week before the scheduled suergery and a follow up 2 days after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate any fear or distress with regard to surgery & anesthesia. |
1 week prior to scheduled surgery at the pre anaesthesia check up clinics & 2 days after the operation. |
| To evaluate the correlation between the education level of an individual & his knowledge & fears of anaesthesia |
At preanaesthesia clinic 1 week prior to scheduled surgery & 2 days after the operation. |
To follow up patients during the postoperative period, 2 days after surgery for any change in their knowledge & perception about anaesthesia & the anaesthesiologist.
|
At the surgical wards 2 days after surgery. |
|
|
Target Sample Size
|
Total Sample Size="361"
Sample Size from India="361"
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)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The present study is a questionnaire based prospective, cross-sectional study that aims to evaluate the present knowledge and perception about anaesthesia and the anaesthesiologist among the patients scheduled for surgrical procedures under
anesthesia. It will also study the correlation of the basic education level of the participants and his/her knowledge of anaesthesia. Any improvement of knowledge and perception of anaesthesia and the anaesthesiologist after the procedures will be recorded.
The study will help to establish better rapport between the anaesthesiologist and the patients, allay their fears of surgery and anaesthesia. It will will lead to better treatment outcomes and highlight the measures necesary to improve the knowledge of
anaesthesia and the anaesthesiologist in the society. |