| CTRI Number |
CTRI/2024/10/075494 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Simulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Simulation Based Training
Regarding Management of Sports Injuries among School Going
Children of Secondary School in Eastern India |
|
Scientific Title of Study
|
Effectiveness of Simulation Based Training on the Knowledge
and Skill Level Regarding Management of Sports Injuries among School Going
Children of Secondary School in Eastern India A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sweta Maji |
| Designation |
M.Sc.Nursing (1st year) |
| Affiliation |
AIIMS kalyani |
| Address |
Room No 108 1 St floor College of Nursing AIIMS Kalyani,Basantapur Saguna kalyani Nadia pin 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
7029660327 |
| Fax |
|
| Email |
swetamaji2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jamuna Rani R |
| Designation |
Associate Professor |
| Affiliation |
AIIMS kalyani |
| Address |
Room No 404 4 th floor College of Nursing AIIMS Kalyani Basantapur Saguna kalyani Nadia pin 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
9894833696 |
| Fax |
|
| Email |
jamuna.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sweta Maji |
| Designation |
M.Sc.Nursing (1st year) |
| Affiliation |
AIIMS kalyani |
| Address |
Room No 108 1 St floor College of Nursing AIIMS Kalyani,Basantapur Saguna kalyani Nadia pin 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
7029660327 |
| Fax |
|
| Email |
swetamaji2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 103 Ground Floor Narayana School Kalyani Town Block B, Rathtala, Krishnadebbati, West Bengal 741235 |
|
|
Primary Sponsor
|
| Name |
Sweta Maji |
| Address |
Room No 108 1 St floor College of Nursing AIIMS Kalyani,Basantapur Saguna kalyani Nadia pin 741245 |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Sweta Maji |
Narayana School , Kalyani |
Block B, Rathtala, Krishnadebbati P, West Bengal 741235
Nadia
WEST BENGAL |
7029660327
swetamaji2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
| Narayana School |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For enriching their skill in sports injury management |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
simulation on sports injury management |
Simulation will be given by using the task trainer on sports injury management after the pre test and the duration of the each injury simulation is 15 minutes there are two injury simulation that is cut and sprain injury and its take total 30 minutes followed by the hand on practice on it then after 15 days post test will be done . |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children studying in class Eight.
2. Willing to participate in the study.
3. Available during the period of data collection.
|
|
| ExclusionCriteria |
| Details |
1. Any Physical and mental illness.
2. Absent during the data collection period.
3. Not given assent for the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the Knowledge and Skill level Regarding Management of Sports Injuries among School Going Children of Secondary School.
2. To determine the Effectiveness of Simulation Based Training on the knowledge and Skill level Regarding Management of Sports Injuries among School Going Children of Secondary School.
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To find out Correlation between the knowledge and skill level Regarding Management of Sports Injuries among School Going Children of Secondary School. |
1month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/10/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Simulation has had a long and varied history in many different fields like in the medical field and it is useful for improving the skill . In the other hand Schools offer an environment where students can acquire skills and develop intelligence that will help them reach their goals in life. Educating children about sports injuries aids in injury prevention and minimizes complications. Simulation based training gives the students the opportunities to practice the management of sports injury and they will be confident to perform in their daily life or in case of help to the others friend. The Secondary school will be selected in the Kalyani. Then prior permission will be taken from the School Authority.60 students of the school will be randomly selected and then they will be randomized into experimental and control groups by Lottery method of 30 students in each group. Then pre test was done with knowledge questionaries and skill by simulation checklist and then the experimental group was given the simulation-based training side by side the control group will not get any intervention, and then both groups will be tested with the same questionnaires. |