FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/084407 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 13/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative Study of Two Teaching Approaches on Newborn lifesaving Skills Among Nursing Students in Tamil Nadu 
Scientific Title of Study   A Study to Assess the Effectiveness of Modified Peytons Approach Vs Gagnes Approach on Neonatal Resuscitation in terms of Knowledge and Skill Acquisition among Nursing Students in Selected nursing colleges at Tamil Nadu 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Melba Sahaya SweetyD 
Designation  Ph.D Scholar in Nursing 
Affiliation  Amity College of Nursing 
Address  Room No A-304, Amity College of Nursing, Amity University,Amity Education Valley, Gurugram (Manesar)

Gurgaon
HARYANA
122413
India 
Phone  956610019  
Fax    
Email  melbachinna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjana Chandran 
Designation  Assistant Professor 
Affiliation  Amity College of Nursing, Amity University 
Address  Room No A-304, Amity College of Nursing, Amity University,Amity Education Valley, Gurugram (Manesar)

Gurgaon
HARYANA
122413
India 
Phone  8925036062  
Fax    
Email  achandran@ggn.amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vijila Berlin S 
Designation  Professor cum Principal 
Affiliation  Global College of Nursing 
Address  Room No 101, Global College of Nursing,Room Edavilagam, Nattalam, Kanyakumari District

Kanniyakumari
TAMIL NADU
629165
India 
Phone  9443682001  
Fax    
Email  gcnmnet@gmail.com  
 
Source of Monetary or Material Support  
Global College of Nursing,103, Edavilagam, Nattalam, Kanyakumari District Tamil Nadu -629165, India 
White Memorial College of Nursing,10/41, Attoor, Veeyannoor post, Kanyakumari District Tamil Nadu -629177, India 
 
Primary Sponsor  
Name  Melba Sahaya sweety D 
Address  Room no- A304, Amity College of Nursing, Amity University, Manesar, Gurugram, Haryana-122413, India 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijila Berlin S  Global College of Nursing, PI: Melba Sahaya Sweety.D  Room No- 101, Department of nursing, Edavilagam, Nattalam, Kanyakumari District
Kanniyakumari
TAMIL NADU 		 9443682001

gcnmnet@gmail.com 
Prof Dr Zoe Sobhana  White memorial College of Nursing, PI: Melba Sahaya Sweety.D  Room No- 210, Department of nursing, Attoor, Veeyannoor post, Kanyakumari District
Kanniyakumari
TAMIL NADU 		 9486869038

wmcn300@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethical Committee, Global College of Nursing  Approved 
Independent Ethical Committee, White Memorial College of Nursing  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Nursing Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gagne’s Approach  For the comparator group Neonatal resuscitation skills will be taught using Gagne’s Approach over 2 weeks, with 120-minute daily sessions for small groups of 10 students. The approach follows nine instructional events: Gaining Attention – Engaging students with neonatal resuscitation images. Informing Objectives – Clarifying learning goals. Recalling Prior Learning – Brief interactive discussion. Presenting Stimulus – Demonstrating the skill step-by-step. Providing Guidance – Encouraging questions and clarifications. Eliciting Performance – Supervised student practice. Providing Feedback – Peer observation and constructive input. Assessing Performance – Independent skill demonstration. Enhancing Retention – Encouraging continued practice for mastery. 
Intervention  Modified Peyton’s Approach  For the intervention Group, the neonatal resuscitation skill will be taught using the Modified Peyton’s Approach. The investigator will divide the participants into smaller groups of eleven and ten, with each session lasting approximately 120 minutes per day over 2 weeks. The Modified Peyton’s Approach consists of seven structured steps to enhance learning and skill acquisition: 1. Construction: The investigator begins by describing the learning objectives, and setting clear goals to prepare students for the upcoming training in neonatal resuscitation. 2. Instruction: The investigator provides comprehensive instruction on neonatal resuscitation, covering key concepts, techniques, and necessary skills. 3. Demonstration: The investigator demonstrates the entire neonatal resuscitation procedure silently, performing each step at a normal pace without any verbal commentary. 4. Deconstruction: The procedure is repeated, but this time the investigator provides a detailed verbal description of each step, breaking down the process for clearer understanding. 5. Comprehension: The students are then asked to verbally explain each step of the neonatal resuscitation procedure while the investigator performs the steps according to the students instructions, ensuring that they fully understand each action. 6. Trial Performance: Students practice neonatal resuscitation skills under minimal supervision, allowing them to reinforce their learning and build confidence in their abilities. 7. Performance Evaluation: will be done by the investigator to assess each students knowledge and skill in neonatal resuscitation using a structured knowledge questionnaire and an observational checklist.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Fourth-year BSc Nursing students who were present during data collection., Both male and female nursing students are included in this study and Nursing students who are willing to participate in the Study  
 
ExclusionCriteria 
Details  The nursing students who are absent at the time of data collection, The nursing students who are sick and not able to participate in the study, and the Nursing students who are not willing to participate in the Study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge on neonatal resuscitation  Time points: Day 1, Day 14, Day 30, Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Skill on neonatal resuscitation  Time points: Day 1, Day 14, Day 30, Day 60 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   15/04/2025 
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="2"
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 - NO
Brief Summary
Modification(s)  

Effectiveness of Modified Peyton’s Approach Vs Gagne’s Approach on Neonatal Resuscitation in Terms of Knowledge and Skill Acquisition Among

Nursing Students in Selected Nursing Colleges at Tamil Nadu

Introduction: Competency in neonatal resuscitation is vital for healthcare professionals, especially in India, where neonatal mortality rates are alarming. Shockingly, UNICEF’s 2020 statistics reveal that 40% of neonatal deaths occur within 24 hours of birth, with 13% preventable due to causes like birth asphyxia and trauma. Empowering nursing students with neonatal resuscitation skills is crucial to combat these issues and reduce mortality rates.

Aim: To assess the effectiveness of Modified Peyton’s Approach versus Gagne’s Approach on neonatal resuscitation among nursing students.

Materials and Methods: A non-randomized parallel arm research design will be carried out in this study, based on the power analysis results, a total of 130 participants will be selected through purposive sampling from four nursing colleges located in Kaniya Kumari district, Tamil Nadu. one colleges will apply the Modified Peyton’s approach, and the other one will use Gagne’s approach. Knowledge of neonatal resuscitation will be assessed through Self-administered structured Knowledge questionnaires, while skill acquisition will be evaluated using observational checklists for neonatal resuscitation.

Plan for Data Analysis: Descriptive statistics will describe demographic variables, and inferential statistics repeated measures ANOVA will assess differences in mean post-scores over three-time points. Pearson correlation will analyze the relationship between knowledge and skill acquisition, and Chi-square tests will compute the associations with demographic variables in both groups.

Conclusion: This study’s results will provide valuable insights for nursing education practices, highlighting the importance of incorporating Modified Peyton’s Approach and Gagne’s approach to better equip nursing students in the domain of neonatal resuscitation. Implementation of this approach has the potential to improve neonatal healthcare delivery and contribute to reducing neonatal mortality rates.

 
Close