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CTRI Number  CTRI/2024/07/070732 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study to determine the effectiveness of the sequential method (flipped classroom method and Peyton’s 4-step teaching method) when compared to Peyton’s 4-step teaching method on the management of foreign body aspiration in children. 
Scientific Title of Study   The sequential method of flipped classroom and Peyton’s 4-step teaching method on the management of foreign body aspiration in children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Shettigar 
Designation  Student of M.Sc. Respiratory Therapy in Neonatal and Pediatric Respiratory Care 
Affiliation  Manipal College of Health Professions 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9844602137  
Fax    
Email  vaishnavipdr2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Leslie Edward S. Lewis 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College, Manipal. 
Address  Department of Pediatrics, KMC, MAHE, Manipal- 576104 Udupi KARNATAKA India

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Vaishnavi Shettigar 
Designation  Student of M.Sc. Respiratory Therapy in Neonatal and Pediatric Respiratory Care 
Affiliation  Manipal College of Health Professions 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9844602137  
Fax    
Email  vaishnavipdr2001@gmail.com  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE, Manipal. 
 
Primary Sponsor  
Name  Vaishnavi Shettigar 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayashree Purkayastha  Manipal College of Health Professions, Manipal.  Department of Respiratory Therapy Room number 515 in 5th floor Division is nil Participants are 1st year B.Sc. Respiratory Therapy of batch 2024-2025
Udupi
KARNATAKA 		 9886249133

jaya.p@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Students of Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Peyton 4 step teaching method   Peyton 4 step teaching method on the management of foreign body aspiration in infants and pediatrics. Peyton 4 step teaching method includes, Step 1: Demonstration: The instructor will be demonstrating the skill related to the management of choking without explaining the procedure/skill. Step 2: Deconstruction: The instructor will demonstrate the technique slowly while explaining each step in detail. Step 3: Comprehension: The participants in the intervention group explain, and the instructor follows through with every step of the process. Step 4: Execution: The participants in the intervention group demonstrate each stage of the process while also explaining the steps. The duration of this comparator is 4 hours. Frequency of comparator is 1 time.  
Intervention  Sequential method  Sequential method i.e. Flipped classroom method and Peyton 4 step teaching method on the management of infants and pediatric Foreign body aspiration. The duration of this intervention includes a total of 6 hours i.e. duration for flipped classroom is 2 hours and Peytons 4 step teaching method is 4 hours The frequency of this intervention is 1 time. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  1) 1st-year students of Respiratory Therapy of the batch 2024-2025 of Manipal College of Health
Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal.
2) Undergraduate students of Manipal College of Health Professions (MCHP) who agree to
participate. 
 
ExclusionCriteria 
Details  1) Undergraduate students who do not agree to participate.
2) Students who are already knowledgeable about the management of infant and pediatric foreign
body aspiration.
3) Students from other courses except B.Sc. Respiratory Therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in the sequential method (flipped classroom method and Peyton’s 4-step teaching method) when compared to Peyton’s 4-step teaching method in acquiring and retaining skills and knowledge by using a percentage of questionnaires and checklists.  Significant improvement in the sequential method compared to Peyton’s 4-step teaching method in acquiring and retaining skills and knowledge will be assessed immediately after the interventions.  
 
Secondary Outcome  
Outcome  TimePoints 
1) Significant improvement in the sequential method in the acquisition & retention of skills by using a percentage of checklists.
2) Significant improvement in the sequential method in the acquisition & retention of knowledge by using a percentage of questionnaires.
3) Significant improvement in Peytons 4 step teaching method in the acquisition & retention of skills by using a percentage of checklists. 		 1) A significant improvement in the sequential method of skill & knowledge acquisition will be evaluated at the post intervention test.
2) A significant increase in knowledge & skill retention using the sequential method will be assessed after 1 & 3 months of intervention.
3) Significant improvement in Peytons 4 step teaching method in skill acquisition will be evaluated at post intervention test & skill retention will be assessed after 1 & 3 months of intervention.  
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   01/08/2024 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vaishnavipdr2001@gmail.com].

  6. For how long will this data be available start date provided 01-01-2029 and end date provided 31-12-2034?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Need of the study:

There is currently inadequate information available on the sequential method of the flipped classroom and Peyton’s 4- step teaching method. In addition, there is currently limited information available regarding the best ways to educate about the management of foreign body aspiration in pediatrics and infants. 

Aims & objectives

This study aimed to assess the effectiveness of the sequential method (i.e. flipped classroom method and Peyton’s 4-step teaching method) when compared to Peyton’s 4-step teaching method on the management of foreign body aspiration in infants and pediatrics. 
Primary objective: To compare the efficacy of the sequential method (i.e. flipped classroom method and Peyton’s 4-step teaching method) and Peyton’s 4-step teaching method to the management of foreign body aspiration in infants and pediatrics. 
Secondary objectives: (1) To assess the effectiveness of the sequential method in the acquisition and retention of skills in the management of foreign body aspiration in infants and pediatrics. (2) To assess the effectiveness of the sequential method in the acquisition and retention of knowledge on the management of foreign body aspiration in infants and pediatrics. 
This study hypothesized that giving educational intervention in the sequential method of the flipped classroom and Peyton’s 4-step teaching method is better for improving the acquisition and retention of skills and knowledge.

Primary Outcome

Significant improvement in the sequential method (flipped classroom method and Peyton’s 4- step teaching method) when compared to Peyton’s 4-step teaching method in acquiring and retaining skills and knowledge by using a percentage of questionnaires and checklists. 
 
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