| CTRI Number |
CTRI/2024/08/072962 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To find out if using Peer teaching for procedural skill training of pediatric post graduates is as effective as faculty teaching |
|
Scientific Title of Study
|
Evaluation of peer teaching and learning process in simulation based procedural skills training for pediatric residents – A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Podhini Jegadeesan |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV |
| Address |
Department of Pediatrics,
Mahatma Gandhi Medical College and Research Institute,
SBV,
Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9566950528 |
| Fax |
|
| Email |
podhini@mgmcri.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Podhini Jegadeesan |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV |
| Address |
Department of Pediatrics,
Mahatma Gandhi Medical College and Research Institute,
SBV,
Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9566950528 |
| Fax |
|
| Email |
podhini@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Podhini Jegadeesan |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV |
| Address |
Department of Pediatrics,
Mahatma Gandhi Medical College and Research Institute,
SBV,
Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9566950528 |
| Fax |
|
| Email |
podhini@mgmcri.ac.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and research Institute, SBV |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute SBV |
| Address |
Cuddalore road, ECR,
Pillayarkuppam,
Puducherry 607402 |
| 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 |
| Podhini Jegadeesan |
Mahatma Gandhi Medical College and Research Institute |
Medical Simulation center, Third floor, College block,
Cuddalore road, ECR,
Pillayarkuppam,
Puducherry - 607402
Pondicherry
PONDICHERRY |
9566950528
podhinij@mgmcri.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Behavioural intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Faculty teaching |
Faculty will be the instructors for the students in control group.
They will teach them by 2 sessions per month for 4 months. |
| Intervention |
Peer Instructor learning |
Peer Instructor who have been trained in pediatric procedural skills by faculty by 2 sessions per month over 4 months, will then be the instructors for the intervention group.
Peer instructors will train the students in intervention group by 2 sessions per month a period of 4 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
All pediatric post graduates in second and first year |
|
| ExclusionCriteria |
| Details |
Post graduate not able to complete training due to any medical or emergency reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean directly observed procedural skills score |
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feedback analysis and focused group discussion analysis by grounded theory |
2 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/08/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - podhinij@mgmcri.ac.in
- For how long will this data be available start date provided 04-08-2025 and end date provided 04-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective interventional study to find out if peer teaching method is as effective as faculty teaching to teach procedural skills for postgraduates will be conducted in Mahatma Gandhi Medical college and research institute, Puducherry. Institute human ethics committee approval has been obtained. We will include 12 second year and 12 first year postgraduates in the study after obtaining informed consent. The second year postgraduates will be initially trained on four common pediatric procedural skills and evaluated using a performance checklist. Once their performance is satisfactory they will be assigned as Peer Instructors. The first year post graduates will be divided into two groups and each will be trained by the Peer instructors and Faculty respectively. At the end of the training the first year postgraduates will be evaluated using a performance checklist and scores between both the groups will be compared and analysed. Feed back will be collected and focus group discussion on the peer instructor teaching and learning method will be collected from all postgraduates and analysed. |