| CTRI Number |
CTRI/2024/09/073728 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to assess the effectiveness of simulation based vs traditional teaching methodology on the school childrens level of knowledge and skill on responding to good and bad touch in selected schools of Gorakhpur |
|
Scientific Title of Study
|
Effectiveness of Simulation Based Vs Traditional Teaching on Knowledge And Skill on Safe and Unsafe Touch among the children in selected schools Of Gorakhpur - A Randomized Control 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 |
Ankita Thakur |
| Designation |
M.Sc. Nursing II year |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
AIIMS Gorakhpur
AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8130879671 |
| Fax |
|
| Email |
ankitathakur7571@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrArun Varghese |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
Department of Psychiatry
All India Institute of Medical Sciences, Kunraghat, Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8194009109 |
| Fax |
|
| Email |
arunvarghese.msc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MrArun Varghese |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS GORAKHPUR |
| Address |
All India Institute of Medical Sciences, Kunraghat, Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8194009109 |
| Fax |
|
| Email |
arunvarghese.msc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
College of Nursing All India Institute of Medical Sciences
Gorakhpur
UTTAR PRADESH
273008 |
| 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 |
| Dr Arun Varghese |
AIIMS Gorakhpur |
Department of Psychiatry
Gorakhpur
UTTAR PRADESH |
8194009109
arunvarghese.msc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of selected schools in Gorakhpur |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation based teaching |
The participants will be given simulation based teaching on safe and unsafe touch through phases such as pre briefing, simulation and debriefing using low cost stuffed toys. |
| Comparator Agent |
Traditional teaching on safe and unsafe touch. |
The study participants will be given traditional didactic lecture cum discussion method based teaching on safe and unsafe touch. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All the students of Sixth to Eight standard irrespective of age studying in the respective schools of Gorakhpur are included in the study |
|
| ExclusionCriteria |
| Details |
The students who will not be present in the school at the time of data collection along with those not consenting to participate in the study will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the pre and post test level of knowledge and skill on safe and unsafe touch among the school children receiving simulation based and traditional teaching. |
The knowledge and skill will be assessed first on the same day and then after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the correlation between the knowledge and skill on safe and unsafe touch among the school children receiving simulation based and traditional teaching.
3.To find the association between the knowledge and skill with the selected demographic variables.
|
The knowledge and skill will be assessed first on the same day and then after 1 week |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| 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="0"
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
|
The study is a randomized control trial that will be conducted amongst the school students in selected schools of Gorakhpur to evaluate the effectiveness of simulation based vs traditional didactic lecture based teaching in improving the knowledge and skill levels among the students on safe and unsafe touch. The sample size will be calculated after the pilot study. The study participants will be randomized using simple random sampling using sequentially numbered envelopes prepared with the help of computer generated random number table. The participants will be allocated to experimental as well as the control groups where the experimental group will receive the simulation based teaching on safe and unsafe touch while the control group will receive the traditional didactic lecture based teaching on safe and unsafe touch. Pre and post test knowledge and skill assessment will be carried out on the same day, knowledge and skill retention will be assessed further after one week and analysis will be carried out. Retention of knowledge and skill will be assessed further at the end of six months in second phase of the trial and after analysis, crossing over will be carried out. The details of the simulation session are as follows: The duration of the session will be for four hours where students will be taught about the concept of safe and unsafe touch using low cost self made stuffed toys. The phases will be as follows; Pre Briefing: Informed consent from the parents/ guardian of the students and pre test along with conveying rules to the learners. Briefing: Reviewing objectives and providing details of the session. Simulation: Giving scenario based teaching to the students using stuffed toys. Debriefing; Short conversation with the students about the type of experience they had during the session. Feedback: Filling up of feedback forms and post test knowledge and skill assessment using knowledge assessment questionnaire/ skill checklist.
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