| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - After researcher scrutiny and IEC committee response
- 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.
- 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. |