| CTRI Number |
CTRI/2025/07/092035 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a short play on helping school boys learn about the dangers of smoking and how to avoid it |
|
Scientific Title of Study
|
Effectiveness of role play on knowledge regarding cigarette smoking and its prevention among adolescent boys in new english junior college wardha
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayli Dilip Gaidhane |
| Designation |
PG student |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Mental Health Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8080187345 |
| Fax |
|
| Email |
sayligaidhane394@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Pooja Kasturkar |
| Designation |
Dean Academics Cum HOD Of Mental Health Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Mental Health Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Pooja Kasturkar |
| Designation |
Dean Academics Cum HOD Of Mental Health Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Mental Health Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
MAHARASHTRA
442001
India |
| Phone |
9673886027 |
| Fax |
|
| Email |
poojakasturkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta meghe institute of higher education and research sawangi ,wardha 442001 India |
|
|
Primary Sponsor
|
| Name |
Datta meghe institute of higher education and researchSawangi Meghe Wardha India |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical 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 |
| Dr Sayli Dilip Gaidhane |
New English School |
Wardha
Wardha
MAHARASHTRA |
08080187345
sayligaidhane394@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,datta meghe institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To Prevent Cigarette Smoking And Increase The Mental Health Knowledge
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Role Play On Knowledge Regarding Smoking And Its Prevention |
Role play on knowledge regarding exam stress and its prevention on adolescents boys |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Male |
| Details |
1 Adolescents students who are willing to Participate in the study
2 Adolescents students who are Available at the time of data collection
3 Adolescents students who are can read and understand English Marathi
|
|
| ExclusionCriteria |
| Details |
1 Adolescents students who are already participated in the similar study
2 Adolescents students who are mentally ill
3 Adolescents who are medical conditions or physical disabilities that prevent participation in outdoor games
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in knowledge about harmful effects and prevention of cigarette smoking among adolescent boys |
Improvement in knowledge about harmful effects and prevention of cigarette smoking among adolescent boys |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in attitude towards cigarette smoking and increased willingness to avoid or refuse smoking |
Assessed one week after the role play during the post-test evaluation
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="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
|
This study aims to assess how effective role play is in improving knowledge about cigarette smoking and its prevention among adolescent boys in New English Junior College, Wardha. A structured role play was conducted, and knowledge levels were compared before and after the activity using questionnaires. Results showed a significant improvement in awareness and understanding, highlighting role play as an effective educational tool. |