| CTRI Number |
CTRI/2022/09/046012 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Simulation Based Learning] |
| Study Design |
Other |
|
Public Title of Study
|
effectiveness of simulation based learning in terms of competency regarding Management of Multisystem Inflammatory Syndrome in Children(MIS-C) among nursing students in selected nursing colleges of Ambala, Haryana |
|
Scientific Title of Study
|
A study to assess the effectiveness of simulation based learning in terms of competency regarding Management of Multisystem Inflammatory Syndrome in Children(MIS-C) among nursing students in selected nursing colleges of Ambala, Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Bhatt |
| Designation |
Student |
| Affiliation |
M. M. College of Nursing, Mullana, Ambala |
| Address |
M. M. College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
9053104787 |
| Fax |
|
| Email |
bhattsimran.025@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogesh Kumar |
| Designation |
HOD Child Health Nursing |
| Affiliation |
M. M. College of Nursing, Mullana, Ambala |
| Address |
M. M. College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana. Pin Code: 133203
Ambala
HARYANA
133203
India |
| Phone |
9053104787 |
| Fax |
|
| Email |
yogesh.dhakar@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Simran Bhatt |
| Designation |
Student |
| Affiliation |
M. M. College of Nursing, Mullana, Ambala |
| Address |
M. M. College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana. Pin Code: 133203
Ambala
HARYANA
133203
India |
| Phone |
9053104787 |
| Fax |
|
| Email |
bhattsimran.025@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.M College of Nursing Mullana Ambala |
|
|
Primary Sponsor
|
| Name |
MM College of Nursing |
| Address |
M.M. College of Nursing, Mullana, Ambala |
| Type of Sponsor |
Other [Nursing College] |
|
|
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 |
| Simran Bhatt |
M.M. College of Nursing, M.M. Institute of Nursing |
Maharishi Markandeshwar(Deemed to be University), Mullana, Ambala
Ambala
HARYANA |
9053104787
bhattsimran.025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
comparison group |
conventional learning |
| Intervention |
simulation based learning |
two parallel simulation based case scenario will be administered for 45 minutes each. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
willing to participate
available at the time of data collection
students studying in BSc nursing 3rd year |
|
| ExclusionCriteria |
| Details |
absent on the day of data collection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of simulation based learning in terms of competency regarding Management of Multisystem Inflammatory Syndrome in Children(MIS-C) among nursing students |
15days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/11/2022 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multisystem Inflammatory Syndrome in Children (MIS-C) has recently being discovered during the time of COVID-19, as the cases of this disease condition is increasing day by day, nursing students need to know more about the disease condition. Hence, a simulation based learning technique can be used to teach the students regarding this disease condition and make them competent enough to deal with this condition effectively. |