| CTRI Number |
CTRI/2021/01/030826 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical virtual simulation is effective in nursing education |
|
Scientific Title of Study
|
Virtual simulation in Nursing Education: A Randomised Controlled trial during Covid-19 crisis period |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashi Mawar |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 2, Porta Cabin College of Nursing, AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shashi Mawar |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 2, Porta Cabin, College Of Nursing, AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashi Mawar |
| Designation |
Associate professor |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 2, Porta Cabin, College Of Nursing, AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
8800228317 |
| Fax |
|
| Email |
drshashimawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Section (Intramural grant), AIIMS, Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS intramural grant |
| Address |
AIIMS, Research Section |
| 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 Shashi Mawar |
AIIMS, Delhi |
College Of Nursing, Room No 2, AIIMS, New Delhi
New Delhi
DELHI |
8800228317
drshashimawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low technology simulation |
Control group will be provided similar clinical scenarios in lab settings and will be performing the management based on their understanding. Inputs will be provided only if asked. |
| Intervention |
Virtual clinical simulation |
Its a type of touch screen physiological algorithm for various clinical situations which students will operate based on their clinical reasoning. The virtual patient will respond as per the students decisions. The student will either be able to successfully manage the patient or will not and then provide feedback as per the performance.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Nursing students enrolled for PG program at AIIMS college of Nursing. |
|
| ExclusionCriteria |
| Details |
Students not consenting for study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge based clinical reasoning |
Baseline, Post intervention Day 1 and 3 months later. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Student satisfaction and self efficacy |
Baseline, Post intervention day 1 and 3 months later |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/04/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published after completion of the trail |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nursing students need to learn and relate theory and practices ensuring quality and safety of the patients. In todays Covid scenario it has become challenging to provide clinical experience in social distancing situation. classroom teachings are also not feasible. virtual clinical simulation will be able to replace clinical hours for students enrolled in nursing program. teaching with virtual simulation offers opportunities to experience in common situations that students are likely to encounter in clinical settings. This study aims to assess the effectiveness of Virtual clinical simulation as a method of teaching Vs Low technology simulation in terms of knowledge, student satisfaction, self efficacy and clinical reasoning.. This prospective RCT on 52 PG nursing students will be conducted in two phases, phase I is development of coding for physiological algorithm and phase II is testing the algorithm on students. After enrolment of the students for trail pre test will be done and then post test after implementation of intervention. One group will be provided education through low technology simulation. Both groups will be compared for outcomes. |