| CTRI Number |
CTRI/2023/06/054019 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparison of two different methods of learning] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of video based e-learning with instructor based learning |
|
Scientific Title of Study
|
Video-based e-learning as an alternative for instructors in teaching basic life support to school
children: a randomized control trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purvi Patel |
| Designation |
Associate Professor |
| Affiliation |
Bhaikaka university |
| Address |
Academic center,Department of pediatrics, Shree Krishna Hospital, Karamsad, Anand-
Anand
GUJARAT
388325
India |
| Phone |
09825661647 |
| Fax |
|
| Email |
evergreen.purvi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvi Patel |
| Designation |
Associate Professor |
| Affiliation |
Bhaikaka university |
| Address |
H M Patel Academic center,Department of pediatrics, Shree Krishna Hospital, Karamsad, Anand-
Anand
GUJARAT
388325
India |
| Phone |
09825661647 |
| Fax |
|
| Email |
evergreen.purvi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Damor |
| Designation |
First year resident |
| Affiliation |
Bhaikaka university |
| Address |
H M Patel Academic center,Department of pediatrics, Shree Krishna Hospital, Karamsad, Anand-
Anand
GUJARAT
388325
India |
| Phone |
09638652215 |
| Fax |
|
| Email |
pradeepdamor449@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pramukh swami Medical college, Bhaikaka university, Karamsad |
|
|
Primary Sponsor
|
| Name |
Dr Purvi Patel |
| Address |
Shree Krishna Hospital, gokalnagar, Karamsad, Anand-388325 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Schools will provide logistic support |
Yet to decide the school names in which we are going to conduct the study. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Purvi Patel |
Pramukh swami medical college, karamsad |
Pediatrics department, Skill lab, shree krishna hospital campus, karamsad
Anand
GUJARAT |
09825661647
evergreen.purvi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionalethicscommittee2,Bhaikakauniversity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents- school going children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
: instructor-based teaching |
The participants of the control group will receive training on the
principles of IAP BLS guidelines as per standardized program [25]. The instructors are certified trainers. Each group
will practice with two resuscitation manikins and two training AEDs |
| Intervention |
video-based e-learning |
g The intervention group will receive link for e-Sanjeevani course and
they will see whole video. We will provide mannikins and AED to do self- practice. In this group, only an observer
was present, who was instructed not to answer any questions coming from the participants. No instructor was
available.
Post-intervention After completing either the instructor course (control group) or the video-based e-teaching
(intervention group), the assessment will be done using same IAP BLS skills assessment checklist 2019 |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All students of selected schools having age between 15 to 18 years |
|
| ExclusionCriteria |
| Details |
Students who are absent on the day of training
ii. Students who are not interested
iii. Students who are not able to do due to any physical or mental problems.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
comparison of clinical skill achievement after doing e-course and instructor led course.
led course |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| See the retentiveness of clinical skills after 3 months of doing the course. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/07/2023 |
| 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
|
No publication done at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The importance of early cardiopulmonary resuscitation (CPR) during an out of hospital cardiac arrest (OHCA) cannot be emphasized enough and has a major impact on survival. Unfortunately, CPR education in schools is often inadequate or non-existing due to lack of educators and financial resources. The introduction of e-learning could facilitate education as no instructor is needed. The aim of present study is to compare e-course selfteaching (intervention group) with a traditional instructor-led course (control group). |