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
|
|
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
|
|
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 |