| 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
|
|
|
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
|
|
|
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. |