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CTRI Number  CTRI/2022/05/042579 [Registered on: 17/05/2022] Trial Registered Prospectively
Last Modified On: 08/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefits of Computer based teaching method on learning and self-confidence among Nursing students  
Scientific Title of Study   Effectiveness of Virtual Simulation teaching method on self-efficacy, learning and self-confidence among Nursing students in North India - A Randomized Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamilselvi Arumugam 
Designation  Professor Cum Principal 
Affiliation  Amity University, Gurugram, Haryana 
Address  Room No 310, Academic Block A, Amity College of Nursing, Amity University, Gurugram

Gurgaon
HARYANA
122413
India 
Phone  9894594932  
Fax    
Email  atamilselvi@ggn.amity.edu  
 
Details of Contact Person
Scientific Query
 
Name  Tamilselvi Arumugam 
Designation  Professor Cum Principal 
Affiliation  Amity University, Gurugram, Haryana 
Address  Room No 310, Academic Block A, Amity College of Nursing, Amity University, Gurugram

Gurgaon
HARYANA
122413
India 
Phone  9894594932  
Fax    
Email  atamilselvi@ggn.amity.edu  
 
Details of Contact Person
Public Query
 
Name  Tamilselvi Arumugam 
Designation  Professor Cum Principal 
Affiliation  Amity University, Gurugram, Haryana 
Address  Room No 310, Academic Block A, Amity College of Nursing, Amity University, Gurugram

Gurgaon
HARYANA
122413
India 
Phone  9894594932  
Fax    
Email  atamilselvi@ggn.amity.edu  
 
Source of Monetary or Material Support  
The Trained Nurses Association of India L-17, Florence Nightingale Lane Green Park Main, New Delhi-110016. 
 
Primary Sponsor  
Name  Tranied Nurses Association of India 
Address  L-17, Florence Nightingale Lane Green Park Main, New Delhi-110016 
Type of Sponsor  Other [Professional Association] 
 
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 
Hariprasath Pandurangan  Amity College of Nursing, Amity University Haryana  Room No 304, Academic Block A, Amity College of Nursing, Amity University Haryana.
Gurgaon
HARYANA 
8265993671

hpandurangan@ggn.amity.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amity University Haryana, institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Myocardial Infarction Nursing Management 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Traditional Teaching Method  Following randomization, students will be assigned to the traditional teaching method group where the students will receive regular teaching on various aspects of Myocardial Infarction and its management.  
Intervention  Virtual Simulation Teaching Method  Following randomization, students will be assigned to the Virtual Simulation teaching method group. In this teaching method the investigator will use Virtual Simulation to simulate the Myocardial Infarction Management Bundle (MIMB), which includes Cardiovascular assessment, Monitoring of Patient with Myocardial Infarction, ECG identification of Myocardial infarction, Laboratory Investigations, Medical and Nursing management of patients diagnosed with Myocardial Infarction. The Virtual Simulation on MIMB will be divided into three phases namely Pre-briefing, simulation Scenario, debriefing. In the Pre-briefing phase investigators will review scenario with students on different aspects of Myocardial Infarction Management Bundle. To promote fidelity and clarify expectations, the investigators will orient students to the simulation room prior to the simulation. In the simulation scenario phase the investigator will simulate scenes on Cardiovascular assessment, Monitoring of Patient with Myocardial Infarction, ECG identification of Myocardial infarction, Laboratory Investigations, Medical and nursing management of patients diagnosed with Myocardial Infarction. In debriefing phase investigators help the students to connect actions taken during scenario with the learning outcomes. The Virtual Simulation will last for 4 hrs and it will be implemented on Day 2.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  All the male and female students who were studying BSc Nursing Programme in prefinal and final year will be included in the study  
 
ExclusionCriteria 
Details  Male and female students those who are not willing participate and on leave during data collection period will be excluded from the study.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the trial is to determine the effectiveness of Virtual Simulation on self - efficacy, learning and self-confidence among nursing student which will be measured by modified universal self-efficacy scale, modified Chamberlain Learning and Self-Confidence.   32nd day and 62nd Day 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of the trial is to determine change in the level of knowledge on cardiovascular assessment, monitoring of the patient, ECG identification of Myocardial Infarction, Laboratory investigation, Medical and Nursing management of Myocardial Infarction which will be measured by Knowledge questionnaire.   32nd day and 62nd Day 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   20/05/2022 
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)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Simulation-based clinical education includes the use of devices, trained people, lifelike virtual environments, and role-playing, not just handling mannequins. With realistic clinical scenarios, simulation-based educational interventions in nursing can train novice as well as experienced nurses, helping them to develop effective non-technical skills, practise rare emergency situations, and provide a variety of authentic life-threatening situations. Both simulation and traditional teaching approaches are useful tools for teaching the learning process. Though both the techniques are effective in teaching nursing students, investigators identified few research gaps in both the novel teaching methods. Furthermore, in the revised basic B.Sc. nursing curriculum 2021, the Indian Nursing Council included simulation-based teaching. All these factors motivated the investigator to conduct a study on effectiveness of simulation on self-efficacy, learning, and confidence among nursing students in North India with the aim of closing the research gaps.

A randomised control trial will be conducted among nursing students in Northern States of India. The prefinal and final undergraduate nursing students will be assigned to either a simulation, or traditional teaching method. The students will learn about Myocardial Infarction Management Bundle (MIMB) through any one of the two teaching methods. The trial aims to determine the effectiveness of simulation on self-efficacy, learning and self-confidence among nursing students. Students’ self-efficacy, learning and self-confidence will be assessed by using modified universal self- efficacy scale and modified Chamberlain Learning and Self-Confidence tool. The secondary outcome is to determine change in the level of knowledge on cardiovascular assessment, monitoring of the patient, ECG identification of Myocardial Infarction, Laboratory investigation, Medical and Nursing management of Myocardial Infarction.

 
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