| CTRI Number |
CTRI/2025/08/093700 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study "Assessing the impact of audiovisual teaching on teenagers’ awareness and behavior about safe earbud use." |
|
Scientific Title of Study
|
ASSESS THE EFFECTIVENESS OF VIDEO ASSISTED TEACHING
ON KNOWLEDGE AND ATTITUDE REGARDING PREVENTION OF
HAZARDS ON USING EARBUD AMONG ADOLESCENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing Smt. Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8855868645 |
| Fax |
|
| Email |
shardul.timande11@gmil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Mourya |
| Designation |
Vice-Principal Cum Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing Smt. Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788276500 |
| Fax |
|
| Email |
archanatej95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Mourya |
| Designation |
Vice-Principal Cum Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing Smt. Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788276500 |
| Fax |
|
| Email |
archanatej95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| 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 |
| Sahil |
Sushil Himmat Singhaka Vidyalay Wardha |
Mahila Ashram Sewagram Road Wardha
Wardha
MAHARASHTRA |
08855868645
mahilaashramdled@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents aged 13–19 years, regular earbud users, willing to participate, mentally fit, and present for both tests were included. Those with ear disorders or hearing issues were excluded. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
“Awareness Module on Earbud Hazards Using Video Teaching” |
The intervention was a 15–20 minute video-assisted teaching program for adolescents, focusing on ear anatomy, ear hygiene, risks of earbud use (like injury and hearing loss), and preventive measures. The video included visuals, narration, and animations to enhance understanding. It was delivered via smartphones or projectors, and its effectiveness was assessed using pre- and post-test questionnaires for knowledge and a Likert scale for attitude. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents who are between age group 16-18 years.
2. Adolescent who are available at the time of data collection
3. Adolescent who read and write Marathi, English and Hindi language.
4. Parents who are willing to participate their adolescent in study with form of written |
|
| ExclusionCriteria |
| Details |
1. Adolescent who are having any mental problem.
2. Adolescent who are having any behavior problem.
3. Adolescent who are already participated in this type of study within 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study demonstrated that the video-assisted teaching program significantly improved adolescents’ knowledge and attitudes regarding the hazards of earbud use. Following the intervention, participants exhibited a better understanding of safe ear care practices and developed a more positive, health-conscious attitude, confirming the program’s effectiveness in enhancing awareness and promoting preventive behaviors. |
The study found that the video-assisted teaching program effectively improved adolescents’ knowledge and attitude regarding earbud hazards. After the intervention, participants showed better understanding of safe ear care and developed a more positive, health-conscious attitude, indicating the program’s success in promoting awareness and preventive behavior. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study was the change in attitude of adolescents toward safe ear care and responsible use of earbuds. It assessed whether the video-assisted teaching not only improved knowledge but also influenced the participants’ willingness to adopt safer behaviors and avoid harmful earbud practices in daily life. |
The secondary outcome, attitude change, was measured at two time points: before the video-assisted teaching (pre-test) and immediately after (post-test), to assess the shift in adolescents’ mindset toward safer earbud use. |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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/ Phase 4 |
|
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 evaluated the effectiveness of a video-assisted teaching program on improving knowledge and attitude regarding the prevention of hazards from earbud use among adolescents. A pre-test, intervention, and post-test design was used. Results showed a significant improvement in both knowledge and attitude after the intervention, indicating that video-assisted teaching is an effective method for promoting safe ear care practices. |