| CTRI Number |
CTRI/2025/11/097862 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [simulation based training ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Simulation-Based Disaster Risk Management on School Childrens Preparedness |
|
Scientific Title of Study
|
Effectiveness Of Simulation Based Disaster Risk Management Strategies On Disaster Preparedness With Reference To Knowledge And Practices Among School Children |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NISHA YADAV |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24,Bagarpur,Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
08923466697 |
| Fax |
|
| Email |
nishay.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Agnihotri |
| Designation |
Associate Professor and Superviser |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 214, First Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24,Bagarpur,Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7018781505 |
| Fax |
|
| Email |
rashmiagnihotri.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Teerthankar Mahaveer University |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24,Bagarpur,Delhi Road, Moradabad
Meerut
UTTAR PRADESH
244001
India |
| Phone |
8923466697 |
| Fax |
|
| Email |
nishay.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nisha Yadav |
| Address |
Phd Ground Floor, Teerthanker Mahaveer College Of Nursing, Teerthanker Mahaveer University,NH-24,Bagarpur,Delhi Road,Moradabad |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Nisha Yadav |
Simulation Based Disaster Management in Meerut District |
millennium public school (C.B.S.C. Affiliated Senior Secondary school), Bagapat Road, Near Bypass Crossing, Meerut
New Era Public School (C.B.S.C. Affiliated), Yadav Colony, Bhola Road, Meerut, U.P.
Meerut
UTTAR PRADESH |
8923466697
nishay.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TEERTHANKER MAHAVEER UNIVERSITY ISTITUTIONAL ETHICS COMMITTEE DENTAL COLLEGE & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Increasing self-confidence through practical skill, realistic Learning and Cost-Effectiveness reduced risk, cost-effectiveness. Enhancing disaster preparedness by providing practical experience,
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Concurrent Control |
The study is a single-arm (pretest and posttest) design. The intervention (simulation-based education) will be compared to the participants own baseline knowledge and practice score on disaster preparedness. |
| Intervention |
Simulation-Based Training On Disaster Preparedness |
The detailed curriculum (3-hour module), with a duration of 3 hours per session, includes an educational session, scenario-based simulation, and debriefing on disaster preparedness.
The total duration of the program will be 1.5 years. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
School children who are willing to participate in the study.
Available at the time of data collection.
|
|
| ExclusionCriteria |
| Details |
School children who are not available during the time of data collection are excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Simulation-based strategies are effective in improving disaster preparedness among schoolchildren by significantly increasing both their knowledge and practical skills. |
Baseline, 2 weeks after intervention, and 6 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
08/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
World Health Organization, more than 2.6 million people have
been affected by natural disasters such as earthquakes, tsunamis, earthquakes,
hurricanes, heat waves, floods, or cold in the last decade. These
injuries cause high mortality (e.g., blunt force trauma, strangulation)
that may interfere with local treatment. Health Management World Health
Organization: A comprehensive guide describing emergency medical care in
disaster situations and treatment of injuries in case of disaster. To reduce the effects of an earthquake, education on
disaster preparedness activities is crucial. Activities related to disaster preparedness are carried out by a wide variety of groups and
individuals, including emergency response agencies, public servants,
corporations, individuals, and those who work for international
non-governmental and humanitarian organizations. People, communities, and
nations work to lessen their vulnerability and enhance their resilience to
disasters through the preparedness and mitigation processes, which were
replicated and elaborated earlier.
RESEARCH HYPOTHESIS: (We
will test the hypothesis at a significance level of 0.05). H1:
The mean post-test knowledge score is significantly higher than the pre-test
knowledge scores of schoolchildren after implementing the simulation-based disaster risk
management strategies on disaster preparedness. H2: The mean post-test practice score is significantly higher than the
pretest practice scores of schoolchildren after implementing the simulation-based disaster risk
management strategies on disaster preparedness. H3:
There is a significant correlation between post-test knowledge and practice
scores on disaster risk management strategies of disaster preparedness.
H4:
There is a significant association between pre-test knowledge and practice
scores on disaster risk management strategies of disaster preparedness of
school children with their selected socio-demographic variables.
|