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CTRI Number  CTRI/2025/08/093755 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   E-Learning microcredential in Paediatric Pain Assessment and Management for Nursing Students  
Scientific Title of Study   Effectiveness of Paediatric Pain Assessment and Management E- Learning (PPAMEL) micro credential on Critical thinking, Knowledge, Attitude and Skills among Nursing Students: A Non-Randomized Controlled Trial 
Trial Acronym  PPAMEL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashal Rashmi Martis  
Designation  PhD Scholar  
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  5th floor, PhD Scholars Room, Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9972816927  
Fax    
Email  rashal.mconmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamatha Shivananda Pai 
Designation  Professor 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  1st floor, Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9448623789  
Fax    
Email  mamatha.spai@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Rashal Rashmi Martis  
Designation  PhD Scholar  
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  5th floor, PhD Scholars Room, Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9972816927  
Fax    
Email  rashal.mconmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal  
 
Primary Sponsor  
Name  Rashal Rashmi Martis 
Address  5th floor, PhD Scholars room, Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher of Education, Manipal, Karnataka, India, 576104 
Type of Sponsor  Other [] 
 
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 Sangeetha Priyadarshini  Manipal College of Nursing,Manipal Academy of Higher Education, Manipal  1st floor, Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, karnataka, India
Udupi
KARNATAKA 		 9844896929

sangeetha.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  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  Control group   The partcipants for control group are 3rd year BSc Nursing students. This group will not be provided with the intervention microcredential. Pre test will be conducted on day 1, followed by standard classroom teachings. Post test one on day 60 and post test two on day 90. Skill assesmnet will be done in the clinical setting using FLACC scale during IV cannulisation procedure.  
Intervention  Paediatric Pain Assessmnet and Mangement E-learning(PPAMEL) microcredential   The participants for the intervention are 3rd year BSc Nursing students.The intervention consists of 6 sections developed using the ADDIE model which will be hosted the universities LMS platform. The duration of this microcredentail will be 120 hours with 4 credit points. Pretest will be conducted on day 1 followed by intervention for 8 weeks. Post test will be conducted on day 60 and post test 2 on day 90. Skill assessement will be done in the clinical setting using FLACC scale during IV cannulisation procedure. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Nursing students of 3rd year BSc Nursing Manipal College of Nursing, MAHE, Manipal.
2. Available during the data collection.
3. Willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Students on long leave due to illness
2. Students who have attended the paediatric pain course earlier
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to help supplement the existing knowledge on pain assessment and management through the e-learning micro credential, measuring the impact among nursing students by improving their overall critical thinking, knowledge, attitude and skills to perform better in caring children with pain.   3 years
 
 
Secondary Outcome  
Outcome  TimePoints 
Empowerment of nursing students on paediatric pain assessment & management through training to be equipped with the necessary evidence-based knowledge of managing paediatric pain.
The e-learning micro credential can be recommended be used in the nursing curriculum & can be added as a credit course. For the future it can be recommended to be integrated with the Indian Nursing Council.
Disseminating the knowledge of paediatric pain assessment & management through conference presentations/ workshops & publications.
Copyright of the module can be used from future reference.

 		 12 weeks 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
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   Phase 1 
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="3"
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   The present study aims to evaluate the effectiveness of Pediatric Pain Assessment and Management E-Learning  (PPAMEL) micro-Credential developed for nursing students using the ADDIE instructional design model and four-quadrant framework. The intervention consists of six structured modules (120 hours) delivered through the university’s Learning Management System (LMS). A Non- Randomised Controlled study design will be used to assess the impact of the e-learning module on critical hinking,  knowledge, attitude, skills, online learning readiness and student satisfaction. Skills will be evaluated through observation of pain assessment during pediatric IV cannulisation  procedure using validated tools such as the FLACC scale. The findings of this study are expected to provide evidence on the effectiveness of e-learning in enhancing nursing students’ critical thinking, knowledge, attitude and skills in pediatric pain assessment and management. 
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