| CTRI Number |
CTRI/2024/08/072418 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Peer Led versus Professional Led Training in Basic Life Support among School Students 14 - 18 years of age |
|
Scientific Title of Study
|
Comparison of Peer Led versus Professional Led Training in Basic Life Support among School Students 14 - 18 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Nazar Ahmed |
| Designation |
PGT Department of Paediatrics |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Paediatrics
Command Hospital Air Force
Old Airport Road Agram Post
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
9706241471 |
| Fax |
|
| Email |
nazarahmed0910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamal Kiran Yenamandra |
| Designation |
HOD Department of Paediatrics |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Paediatrics
Command Hospital Air Force
Old Airport Road Agram Post
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
8009537637 |
| Fax |
|
| Email |
drykkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamal Kiran Yenamandra |
| Designation |
HOD Department of Paediatrics |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Department of Paediatrics
Command Hospital Air Force
Old Airport Road Agram Post
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
8009537637 |
| Fax |
|
| Email |
drykkiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Air Force, old airport road, Bangalore, India - 560008 |
|
|
Primary Sponsor
|
| Name |
Mohammad Nazar Ahmed |
| Address |
Command Hospital Air Force
Old Airport Road Agram Post Bengaluru 560007 |
| 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 Kamal Kiran Yenamandra |
Command Hospital Airforce Bengaluru |
Pediatric ward , Command Hospital , 2nd floor , Family Wing , Room No. 3
Bangalore
KARNATAKA |
8009537637
drykkiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Airforce Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Professional led Training in Basic Life Support among school students 14 -18 years of age |
| Intervention |
Intervention group |
Peer led Training in Basic Life Support among school students 14 -18 years of age during the study period of 18 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Students from classes 9, 10, 11, 12 in school in Bangalore
2. Participants and their parents or guardian must express willingness to participate in the study by providing informed consent
3. School student interested in serving as peer educator will be included after obtaining their consent and the consent of their parents or guardians.
4. Students included in the study must have a history of regular school attendance to ensure a consistent level of exposure to educational settings |
|
| ExclusionCriteria |
| Details |
1. Students or their parents/guardians who decline to participate or withdraw consent at any stage
2.Students with pre existing medical conditions that may limit their ability to participate in the BLS training or assessments
3. Students who have received formal Basic Life Support (BLS) training before the study
4. Individuals with a known history of trauma, severe anxiety, or psychological conditions that may be exacerbated by participation in BLS training or assessments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare proportion of participants who would ensure adequate chest compression depth among the study groups.
2. To compare proportion of participants who could ensure mouth to mouth breathing and adequate breath rate among the study groups. |
Baseline
6 weeks after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare retention of BLS knowledge among the study groups |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
26/08/2024 |
| 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 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
|
Peer-led training has
been successfully implemented in various educational settings, capitalizing on
the unique dynamics and communication styles among peers. It offers the
possibility of creating a more comfortable and relatable learning environment
for students, potentially enhancing engagement and knowledge retention. Peer-led
BLS training empowers students to take on roles of responsibility and
leadership within their school community. This not only enhances their
self-esteem but also cultivates a sense of duty towards the well-being of others.
Utilizing peer instructors can be a cost-effective approach for schools, as it
minimizes the need for external professional trainers. Moreover, the skills
acquired by students can be perpetuated through peer-led initiatives,
contributing to long-term sustainability.
The purpose of this
research is to compare the effectiveness of peer-led BLS training with
traditional health professional-led training among high school students. The
study focuses on specific objectives to evaluate key aspects of BLS performance
and knowledge retention within these two training modalities. |