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CTRI Number  CTRI/2025/12/098491 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare Peyton’s Four-Step Approach and the traditional teaching method in improving nursing students’ skills, confidence, and satisfaction at a college in Udupi district, Karnataka. 
Scientific Title of Study   Effectiveness of Peyton’s Four Step Approach (PFSA) versus traditional method on skill acquisition, self-efficacy and satisfaction among undergraduate nursing students at a selected college in Udupi district, Karnataka- A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Roychowdhury 
Designation  MSc Nursing student 
Affiliation  Manipal College of Nursing, Manipal 
Address  Fourth floor,Room 400A,Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8777674087  
Fax    
Email  aditi24601@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sulochana B 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing, Manipal 
Address  Ground floor,Room 005,Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844995784  
Fax    
Email  sulochana.k@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mitchelle S Lewis 
Designation  Lecturer 
Affiliation  Manipal College of Nursing, Manipal 
Address  Third floor,Room 303,Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7259693480  
Fax    
Email  lewis.mitchelle@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka 576104 India  
 
Primary Sponsor  
Name  Aditi Roychowdhury 
Address  Room 401, Fourth floor, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka 
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 Sulochana B  Manipal College of Nursing  3rd floor, Nursing Foundation Lab 1 and Lab 2, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA 
9844995784

sulochana.k@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Demonstration-Redemonstration Method  Demonstration-Redemonstration method is the standard teaching method used for skill training in the college. Here, the teacher will demonstrate and explain the procedure while the student observes and later performes on their own. 
Intervention  Peytons Four Step Approach (PFSA)  Peyton’s Four Step Approach (PFSA) is a teaching method that breaks down teaching clinical skills into four distinct steps which are 1.demonstration where the trainer demonstrates the procedure without commentary 2.deconstruction where the trainer demonstrates the procedure with explanation 3.comprehension where the learner guides the teacher through the steps and 4. performance where the learner executes the procedure independently.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  BSc Nursing students currently enrolled in the 2nd semester at a selected college in Udupi who consent to take part in the study. 
 
ExclusionCriteria 
Details  Students who refuse or are unable to provide informed consent and students who are not present at the time of data collection. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes to be measured are skill acquisition of cardiac and respiratory system assessment, students’ satisfaction with the training method, and self-efficacy in performing the skills.  At baseline and 2 weeks after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   01/01/2026 
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 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  After researcher scrutiny and IEC committee response

  6. For how long will this data be available start date provided 29-12-2026 and end date provided 29-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Teaching methods influence students’ competence, self-efficacy, and satisfaction. Traditionally, clinical skill training has followed the demonstration-redemonstration model, where the students learn the skill by observing the tutors, but this method has shown notable limitations in promoting skill retention and building confidence among learners. To overcome these challenges, structured and learner-centered models like Peyton’s Four-Step Approach (PFSA) are being explored.
Peyton’s Four-Step Approach is a four step method of skill training consisting of: (1) Demonstration where the trainer performs the entire procedure without commentary, (2) Deconstruction where the trainer again performs the entire procedure with explanation, (3) Comprehension where the learner guides the teacher through the steps, and (4) Performance where the learner executes the procedure independently. 
This parallel group Randomized Controlled Trial will be conducted among the students studying in 2nd semester BSc Nursing in Manipal College of Nursing, Manipal Academy of Higher Education, Karnataka. The required sample of students will be selected randomly using a computer-generated random number generator from the entire batch of 2nd semester BSc Nursing (2025-2026 batch). The selected students will be randomly allocated into two groups (Intervention group and Control group). The study will take place in the Fundamentals of Nursing Laboratory (A & B) of the college. The control group students will be taught using the demonstration-re-demonstration method, which is the standard teaching method used for skill training in the college, where, the teacher will demonstrate and explain the procedures for assessing the cardiac and respiratory systems while the student observes.
For the Intervention Group, the skills will be taught using PFSA, which includes the following 4 steps:
Step 1: Demonstration: The instructor will perform the entire skill of cardiac assessment and respiratory assessment at a normal pace without commentary. The students will only observe.
Step 2: Deconstruction: Instructor will repeat the skill but explain each step in detail, breaking it into parts (e.g., patient preparation, position, etc.). In this step, students may ask questions.
Step 3: Comprehension: The instructor repeats the skill with the guidance of the students, as they verbally direct each step of the procedure.
Step 4: Performance: The student carries out the skill on their own, while describing the steps. After the Implementation of the training, the students will be assessed for their skill acquisition immediately after the training using the OSCE checklists by the trainers. After 2 weeks, skill acquisition will be reassessed through a structured OSCE by the primary investigator, using the same OSCE checklists. Students’ satisfaction with the training method will be evaluated after two weeks using a self-structured Student Satisfaction Level Scale, while their self-efficacy will be assessed using the Learning Self-Efficacy Scale (L-SES).
Data will be analyzed using descriptive and inferential statistics using Jamovi software. 
 
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