| CTRI Number |
CTRI/2025/09/094423 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Pre-Post Experimental Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on giving awareness to the teachers on how to handle the student while asthma attack. |
|
Scientific Title of Study
|
Bridging the Knowledge Gap in Bronchial Asthma: A Pre-Post Awareness-Based Study on Teachers Education in School Setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC-4/2025/084 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashlita Carol Mendonca |
| Designation |
Student |
| Affiliation |
Yenepoya School of Allied Health Sciences |
| Address |
MSc. in Respiratory Therapy (Student)
Department of Respiratory Therapy
Yenepoya School of Allied Health Sciences
Yenepoya (Deemed to be University)
Kurnad post, Bantwal Tq - 574153, Karnataka, India
Dakshina Kannada KARNATAKA 574153 India |
| Phone |
9591149322 |
| Fax |
|
| Email |
mendonca.ashlita15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ms Kavya Shettigar K |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya School of Allied Health Sciences |
| Address |
Guide,
Department of Respiratory Therapy,
Yenepoya School of Allied Health Sciences,
Yenepoya (Deemed to be University),
Kurnad post, Bantwal Tq - 574153, Karnataka, India
Dakshina Kannada KARNATAKA 574153 India |
| Phone |
9741734428 |
| Fax |
|
| Email |
kavyashettigar@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Ms Anjali Kotian |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya School of Allied Health Sciences |
| Address |
Co-Guide,
Department of Respiratory Therapy,
Yenepoya School of Allied Health Sciences,
Yenepoya (Deemed to be University),
Kurnad post, Bantwal Tq - 574153, Karnataka, India
Dakshina Kannada KARNATAKA 574153 India |
| Phone |
9071063531 |
| Fax |
|
| Email |
anjalikotian@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya School of Allied Health Sciences
Yenepoya (Deemed to be University)
Kurnad post, Bantwal Tq - 574153, Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Ashlita Carol Mendonca |
| Address |
MSc. in Respirtory Therapy(Student)
Depatment of Respiratory Therapy
Yenepoya School of Allied Health Sciences
Yenepoya (Deemed to be University)
Kurnad post, Bantwal Tq - 574153,Karnataka,India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashlita Carol Mendonca |
Deralakatte Public School |
Deralakatte,Mangaluru,Dakshina Kannda -575018, Karnataka, India Dakshina Kannada KARNATAKA |
9591149322
mendonca.ashlita15@gmail.com |
| Ashlita Carol Mendonca |
Dr. APJ Abdul Kalam Residential PU College |
Assaigoli,Mangaluru,Dakshina Kannda- 574199,Karnataka, India Dakshina Kannada KARNATAKA |
9591149322
mendonca.ashlita15@gmail.com |
| Ashlita Carol Mendonca |
Dr. APJ Abdul Kalam Residential School |
Assaigoli,Mangaluru,Dakshina Kannada -574199, Karnataka,India Dakshina Kannada KARNATAKA |
9591149322
mendonca.ashlita15@gmail.com |
| Ashlita Carol Mendonca |
Jnana Deepa High School |
Mudipu,Mangaluru,Dakshina Kannada -574153, Karnataka,India Dakshina Kannada KARNATAKA |
9591149322
mendonca.ashlita15@gmail.com |
| Ashlita Carol Mendonca |
Netaji Subhash Chandra Bose Government High School |
Derlakatte,Mangaluru,Dakshina Kannda -575018, Karnataka, India Dakshina Kannada KARNATAKA |
9591149322
mendonca.ashlita15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Deralakatte Public School |
No Objection Certificate |
| Dr. APJ Abdul Kalam Residential PU College |
No Objection Certificate |
| Dr. APJ Abdul Kalam Residential School |
No Objection Certificate |
| Jnana Deepa High School |
No Objection Certificate |
| Netaji Subhash Chandra Bose Government High School |
No Objection Certificate |
| Yenepoya Ethics Committee - 4 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Teachers in primary, higher primary, secondary and higher secondary schools at Ullal Taluk.
Teachers who agreed to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Teachers who have already undergone asthma education within the past 6 months.
Teachers who are on long-term leave, maternity leave, or administrative duty during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if the educational session improves teachers’ knowledge about bronchial asthma. |
Baseline, 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the long-term retention of the knowledge gained from the educational session. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
22/09/2025 |
| 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="0" Months="5" 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
|
Bronchial asthma is a chronic respiratory condition affecting children worldwide. Teachers play a vital role in managing asthma in School. Providing them with proper education can help improve disease control, reduce hospital visits, and enhance their children’s quality of life. The hypothesis of the study is that an education-based awareness program improves teachers’ knowledge of bronchial asthma. Therefore, this study aims to evaluate the effectiveness of an educational session in improving teachers’ knowledge about bronchial asthma in children. Scientific review board and Institutional Ethics Committee approval will be obtained prior to the commencement of the study. Informed consent will be obtained by the Principal Investigator from the study participants in a language that the participants fully understand. A participant information sheet will be provided, detailing the study’s purpose and procedures. The informed consent will be taken. Data will be collected using the Teacher’s Knowledge Asthma Questionnaire. The initial knowledge of the techers will be assessed using this questionnaire before the the educational program(Patient Education Materials Assessment Tool for Audiovisual Materials), which will be provided right before the educational program. The educational program will be conducted immediately after the questionnaire. One week later and one month later after the educational program, post-test questionnaire will be taken, same manner as the pre-test to evaluate knowledge improvement.The Questionnaire, contains 28 questions designed to evaluate a teacher’s understanding of the condition. The time required to complete the questionnaire is roughly around 15 to 20 minutes. |