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CTRI Number  CTRI/2026/01/100271 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Simulation]  
Study Design  Other 
Public Title of Study   Assessing Simulation training as a teaching method for Physiotherapy Students to safely move ICU Patients 
Scientific Title of Study   Effectiveness of Simulation Based Training in Enhancing the Skills of Undergraduate Physiotherapy Students for Early Mobilization of Intensive Care Unit Patients: A Mixed Method Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gatty Aishwarya Prabhakar 
Designation  Assistant Professor  
Affiliation  Department of Cardiorespiratory Sciences, Father Muller College of Physiotherapy 
Address  Department of Cardiorespiratory sciences, Father Muller College of Physiotherapy, Father Muller road, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8971846776  
Fax  -  
Email  ashgatty95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meghna Mukund 
Designation  Professor  
Affiliation  Department of Emergency Medicine Yenepoya Medical College Yenepoya (Deemed to be University) 
Address  Department of Emergency Medicine Yenepoya Medical College Yenepoya (Deemed to be University)

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9880432714  
Fax  -  
Email  meghnamukund@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gatty Aishwarya Prabhakar 
Designation  Assistant Professor  
Affiliation  Father Muller College of Physiotherapy 
Address  Department of Cardiorespiratory sciences, Father Muller College of Physiotherapy, Father Muller road, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  8971846776  
Fax  -  
Email  ashgatty95@gmail.com  
 
Source of Monetary or Material Support  
Material support and Infrastructure Support by Father Muller Simulation and Skill Center (FMSSC), Father Muller Charitable Institutions, Father Muller Road, Kankanady Mangalore-575002, Karnataka, India and ACTS-Yen, Yenepoya University(Deemed to be University) 8th Floor EMD Building Yenepoya Medical College Hospital University Road, Deralakatte, Mangalore 575018, Karnataka, India 
 
Primary Sponsor  
Name  Self 
Address  Department of Cardiorespiratory Sciences, Father Muller College of Physiotherapy 
Type of Sponsor  Other [Self] 
 
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 
Gatty Aishwarya Prabhakar  Advanced Comprehensive Clinical Training and Simulation Centre (ACTS-Yen)  Yenepoya University(Deemed to be University) 8th Floor EMD Building Yenepoya Medical College Hospital University Road, Deralakatte, Mangalore 575018.
Dakshina Kannada
KARNATAKA 		 8971846776
-
ashgatty95@gmail.com 
Gatty Aishwarya Prabhakar  Father Muller Simulation and Skill Center (FMSSC)  Father Muller simulation and skill centre, Father Muller Road, kankanady, Mangalore 575002
Dakshina Kannada
KARNATAKA 		 8971846776
-
ashgatty95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
Yenepoya Ethics Committee 2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undergraduate students studying Cardiorespiratory Physiotherapy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lecture Bases teaching+ Demonstration  A validated PPT on Early Mobilization in Intensive Care Unit including the following contents: Introduction, Effects of Early Mobilization, Safety measures for Early Mobilization, Devices used, Adjunct Procedures will be provided to the students in both the groups atleast 1 week prior to the sessions. Classroom lecture for 1hour 30 mins will be conducted for the control group by the primary investigator. This will include teaching the theoretical aspects early mobilization.using the validated PowerPoint Presentation and demonstration of early mobilization from supine to standing on a manikin in the simulation center. Duration: One lecture class for 1 hpur 30 mins will be conduted  
Intervention  Simulation Based Training  A validated PPT on Early Mobilization in Intensive Care Unit including the following contents: Introduction, Effects of Early Mobilization, Safety measures for Early Mobilization, Devices used, Adjunct Procedures will be provided to the students in both the groups atleast 1 week prior to the sessions. A simulation training module will be prepared for training the participants for early mobilization. Specific learning objectives (SLO) will be framed with proficiency as novice and targeting skills, attitude and cognitive domains. Scenario template of the centres will be used to ensure appropriate format of the scenario. A step by step content procedure will be used to validate the module. For implementation of the simulation scenario, allotted number of participants-5-6 in each session- will fill a pre-test with 10 MCQs and modified self-efficacy survey to assess their self-efficacy. They will be pre briefed by the primary investigator for ten minutes. The participants will be pre-briefed according the pre-brief script to maintain uniformity. The ground rules for participating in a simulation scenario will be explained. (Confidentiality and Privacy, Fiction contrast, Safe environment, Mutual respect) They will be provided with an opportunity to familiarize with the manikins and the equipment. The simulation case scenario will be performed for a period of 10 minutes. The progression of the scenario will be managed by the simulation technician from the control room. Cues will be provided by confederate (nurse)if required to facilitate the participants. They will be observed by the primary investigator and the points to be debriefed will be noted down. After the scenario, the participants will be participating in debriefing session facilitated by the primary investigator for 20 minutes. The debriefing will be conducted in four phases: Reactions, Description, Analysis, Summary. A combination of directed feedback, delta plus and advocacy inquiry will be used.46 A post-test and the modified self-efficacy survey will be conducted for both the groups and feedback regarding the training will be requested from the participants. The duration for implementation of these steps will be approximately 1 hour 30 minutes. Duration-One simulation session for 1 hour 30 mins  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  Undergraduate Physiotherapy students (III-year Bachelor of Physiotherapy) studying Cardiopulmonary Physiotherapy  
 
ExclusionCriteria 
Details  1.Students who will be absent for OSCE assessment
2.Students repeating the academic year ((These students will be included in the simulation sessions but data will not be included
for the study) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Objective Structured Clinical Examination (OSCE)
2. Students Perception using Focused Group Discussion 		 1. Atter 1 week of the session
2. Same day of the session  
 
Secondary Outcome  
Outcome  TimePoints 
1. Pre Test & Post Test-MCQs
2.Self Efficacy Scale (Adapted Version) 		 1. & 2.
Baseline (Before the session), After the session (Same day) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/01/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   This study will involve five objectives starting with needs assessment for simulation based training in cardiorespiratory physiotherapy. This will be assessed through a validated questionnaire that will be circulated among the cardiorespiratory physiotherapists. The second objective will involve preparing and validating a simulation training model for teaching the students the skills used in Early Mobilization of patients in the Intensive Care Unit. The third objective will include training students using the validated simulation model or the lecture method depending on the groups they are allotted into. The simulation training will include pre-briefing, simulation scenario and debriefing for a duration of one hour and a half. The lecture group will be having a theory session for one hour and a half including the demonstration of phases on early mobilization. The fourth objective includes assessment of effectiveness using an adapted self-efficacy questionnaire and observed structural clinical examination (OSCE). The fifth objective involves assessment of perspectives of participants regarding simulation based training by conducting a focused group discussion with the participants. 
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