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CTRI Number  CTRI/2020/10/028318 [Registered on: 09/10/2020] Trial Registered Prospectively
Last Modified On: 30/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study patients awareness about factors which affect the outcome of their surgery and their participation in contributing to their own safety during surgery. 
Scientific Title of Study   A study of patients knowledge and awareness of patient factors influencing peri-operative risks and their perception of patient participation in enhancing their own perioperative safety. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyotsna Agarwal 
Designation  Associate Professor (Anaesthesia) 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Critical Care, 8th floor, block B, Hamdard Institute of Medical Sciences and Research Hospital
New Delhi 110062
South
DELHI
110016
India 
Phone  9650252828  
Fax    
Email  jyotsna.doctor@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jyotsna Agarwal 
Designation  Associate Professor (Anaesthesia) 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Critical Care, 8th floor, block B, Hamdard Institute of Medical Sciences and Research Hospital
New Delhi 110062
South
DELHI
110016
India 
Phone  9650252828  
Fax    
Email  jyotsna.doctor@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jyotsna Agarwal 
Designation  Associate Professor (Anaesthesia) 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Critical Care, 8th floor, block B, Hamdard Institute of Medical Sciences and Research Hospital
New Delhi 110062
South
DELHI
110016
India 
Phone  9650252828  
Fax    
Email  jyotsna.doctor@gmail.com  
 
Source of Monetary or Material Support  
Hamdrad Institute of Medical Sciences and Research and associated Hakim Abdul Hamid Centenary Hospital 
 
Primary Sponsor  
Name  Hamdard Institute of Medical Sciences and Research New Delhi 
Address  Hamdard Nagar, New Delhi 110062 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyotsna Agarwal  Hamdard Institute of Medical Sciences and Research, New Delhi  Operation Theatre complex, 8th floor, block B, Hamdard Institute oF Medical Sciences and Research, New Delhi
South
DELHI 
9650252828

jyotsna.doctor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z038||Encounter for observation for other suspected diseases and conditions ruled out,  
 
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  All patients aged between 18-70 years of age
Orthopedic / General surgery
Elective procedure
 
 
ExclusionCriteria 
Details  Patients <18 years, > 70 years of age
Patients posted for emergency surgery
Patients having psychiatric disorders, speech and hearing problems
Patient refusal to participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess patient information of ‘patient factors’ influencing perioperative risks
2. To assess patient perception of ‘their involvement in enhancing their own perioperative safety’
 
At the time of data collection 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess patient awareness about anaesthesiology and anaesthesiologists
2. To assess patient apprehensions about anaesthesia
3. To collect patient suggestions about improvement in perioperative patient care
 
2 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="163" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2020 
Date of Study Completion (India) 31/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

With the growing involvement of anaesthesiologist in various areas of patient care, anaesthesiologist has become an important health care worker associated with patient management, patient safety and patient satisfaction. World Health Organization identifies surgical safety and medication safety as important Global Patient Safety Challenges - Anaesthesiologist is an intrinsic part of these areas. An informed and aware patient can help the clinician in providing better care. Patient engagement and active participation improves patient safety and reduces errors.  Some studies have been conducted about ‘awareness of anaesthesia specialty’ in patients. All have revealed the dismal state of awareness and knowledge about this critical branch in the patient population. Most studies are done in rural population and in peripheral locations of the country. Knowledge of patient’s information about anaesthesia, its risks and patient factors influencing these can help in providing better care to the patient. None of these surveys have studied the patient information specific to areas which would influence patient safety perioperatively. Preformed questionnaire with ten questions is prepared by the study investigators. The questions would be asked to the patient in his own language by a member of anaesthesia team (doctor). After interviewing the patient, the doctor will fill the questionnaire and submit the performa in the folder. The performas would be evaluated by the investigators who would be blind to the patient surveyed. Flexibility will be allowed to add relevant questions and record unanticipated patient responses during the course of study . We propose to study the patient awareness of ‘patient factors influencing perioperative risks’ and their perception about ‘patient participation in enhancing their own perioperative safety. Patient information of ‘patient factors involved in perioperative risk’ and patients perception about ‘their role in enhancing their own perioperative safety’ have never been investigated in our country.

As a part of the interview, patients would be educated about these areas. Based on its findings, patient education program will be planned to educate, empower and engage patients in enhancing their own perioperative safety. It will also help the patients and their families to have an insight in the potential perioperative complications and better acceptance of complications in adverse situations. This study will serve as a pilot project and based on its findings, multicenter survey and patient education program will be planned

 
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