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CTRI Number  CTRI/2025/08/092372 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Medical Education]  
Study Design  Other 
Public Title of Study   Hands-On-Learning of Simulation-based Auscultation Skills 
Scientific Title of Study   Effectiveness of simulation based education of clinical psychomotor skill of cardiovascular and respiratory auscultation in medical undergraduates: A prospective interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonia Kochhar 
Designation  Additional Professor and Officiating Head 
Affiliation  AIIMS Bathinda 
Address  Department of Physiology All India Institute of Medical Sciences Bathinda Punjab 151001

Bathinda
PUNJAB
151001
India 
Phone  9896672381  
Fax    
Email  kochhar.sonia.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia Kochhar 
Designation  Additional Professor and Officiating Head 
Affiliation  AIIMS Bathinda 
Address  Department of Physiology All India Institute of Medical Sciences Bathinda Punjab 151001

Bathinda
PUNJAB
151001
India 
Phone  9896672381  
Fax    
Email  kochhar.sonia.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonia Kochhar 
Designation  Additional Professor and Officiating Head 
Affiliation  AIIMS Bathinda 
Address  Department of Physiology All India Institute of Medical Sciences Bathinda Punjab 151001

Bathinda
PUNJAB
151001
India 
Phone  9896672381  
Fax    
Email  kochhar.sonia.dr@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Sonia Kochhar 
Address  A 312 Department of Physiology All India Institute of Medical Sciences, Bathinda Punjab 151001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonia Kochhar  All India Institute of Medical Sciences  Room No. 312, Department of Physiology, A Block Medical College Building
Bathinda
PUNJAB 
9896672381

kochhar.sonia.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bathinda  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  Post-test and assessment will be conducted and clinical skills will be evaluated on validated checklist.   Students will be divided equally in two groups (Group A & Group B). Simulation based training of respiratory auscultation will be given to group A and Simulation based training of heart sound auscultation will be given to group B in small groups of 5 students in each group. Post test and assessment will be conducted after simulation based training and feedback will be collected in the form of questionnaire. In next session simulation based training of cardiac auscultation will be done in Group A and respiratory auscultation will be done in Group B. Post-test and assessment will be conducted and clinical skills will be evaluated on validated checklist. 
Intervention  simulation-based training   All students will be given prerequisite knowledge in an interactive lecture in a large group, in two separate classes of cardiovascular system, regarding heart sounds and respiratory system examination. Large group teaching will be followed by demonstration and training of both the psychomotor skills in small groups. Small group training of the skills will be done using Peyton’s 4-step teaching approach. Pre-test will be conducted and assessment of clinical skills will be done by giving scenario-based problems. The duration of the study will be 6 months. Students will be divided equally in two groups (Group A & Group B). Simulation-based training of respiratory auscultation will be given to group A and simulation-based training of heart sound auscultation will be given to group B in small groups of 5 students in each group. Post-test and assessment will be conducted after simulation-based training within a month and feedback will be collected in the form of a questionnaire. In the next session, simulation-based training of cardiac auscultation will be done in Group A, and respiratory auscultation will be done in Group B. Post-test and assessment will be conducted, and clinical skills will be evaluated on a validated checklist again within 1 month of training.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  All students who will give consent and attend training and assessment sessions 
 
ExclusionCriteria 
Details  Students who will be absent and non-consenting students 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Medical students will be more confident in performing auscultation of respiratory and cardiovascular system on patients. They will show enhanced psychomotor and cognitive skills  The pre-test will be taken before each intervention as baseline.
Post-test will be taken after each intervention within 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Effective teaching of psychomotor skills is the benchmark of medical education in present scenario of advancing medical technologies , academics and research. A medical undergraduate needs to be trained holistically to be competent in not only cognitive skills but psychomotor skills also. Medical education  is challenging for every undergraduate as they are assimilating new knowledge along with learning of necessary psychomotor skills. Teaching clinical skills to first year medical undergraduates is an exigent task for faculty facilitators as they need to appreciate the balance between knowledge and clinical practice. Looking forward on understanding and learning of psychomotor skills it was seen in gap analysis that first year medical students felt a strong need for better understanding and learning of psychomotor skill of auscultation in cardiovascular system and respiratory system. Simulation based learning of psychomotor skills provides real time experience for medical undergraduates to learn vital skills like cardiac and respiratory auscultation in safe environment. It is an effective tool for training students in respiratory care education.(1) This simulated clinical environment helps medical student to have in-depth learning of essential clinical skills and prepare them clinically for accurate differential diagnosis in their forthcoming clinical posting. It was seen that training of cardiac auscultation significantly improved auscultatory skills in students in which 89.7% students were able to recognize mitral regurgitation on the simulated patient.(2) Students who are trained with simulation based tutoring shows better skill performance and confidence to identify lung sounds as compared to students who were just tutored without simulation. (3)Thus simulation based education also helps learner to have diverse exposure to auscultatory abnormalities that can be encountered in a patient. It gives opportunity and access to undergraduates to simulated patients in institution where exposure to real patients is less. Simulation based learning also ensures patient safety as student can learn and rehearse on patient simulator. In a study done on residents of cardiology specialty school it was seen that residents trained by simulation based education were having better auscultatory skills then residents who were trained in conventional manner.(4) Assessment on simulators will provide clinical scenario to the medical student which will help expand their cognitive clinical skills.(5) This study will therefore enhance their clinical skills and help us to understand effectiveness of simulation based education among medical students in auscultatory psychomotor skills in cardiovascular and respiratory system.  

Rationale and Justification: Simulation based education will provide Indian medical graduates a state of the art platform for learning vital clinical skills which is a must know to do clinical practice. Simulation based learning is a real time learning where students can practice and rehearse to learn and polish their clinical psychomotor skills. It will help them interpret auscultator abnormalities and enhance clinical cognitive skills, thus promoting patient safety. Novelty of the study includes scenario based learning and assessment on simulators.

AIM:

To study effectiveness of simulation based learning of auscultatory skills in cardiovascular and respiratory system among first year medical undergraduate students.

Objectives:

1.     To assess efficacy of simulation based learning of auscultation in cardiovascular system

2.     To assess efficacy of simulation based learning of auscultation in respiratory system

Methodology:

Study type: prospective interventional study

Study settings: Study will be conducted in Department of Physiology , AIIMS Bathinda  among medical undergraduates.

Study Duration : 6 months

Study Population: Purposive sampling (all first year medical undergraduates)

Inclusion criteria: All students who will give the consent and attend training and assessment sessions.

Exclusion criteria: students who will be absent and non consenting students.

 

Study Intervention:

At the level of Faculty: Sensitization session on simulation based training of auscultation in respiratory and cardiac examinations will be conducted among medical faculty of Department of Physiology. Faculty will be appraised of Peyton’s 4 step approach to teach clinical skills in small group.

At the level of Students: All students will be given pre requisite knowledge in an interactive lecture in large group, in two separate classes of cardio vascular system regarding heart sounds and respiratory system examination. Large group teaching will be followed by demonstration and training of both the psychomotor skills in small groups. Small group training of the skills will be done using Peyton’s 4 step teaching approach. Pre-test will be conducted and assessment of clinical skills will be done by giving scenario based problems.

Students will be divided equally in two groups (Group A & Group B). Simulation based training of respiratory auscultation will be given to group A and Simulation based training of heart sound auscultation will be given to group B in small groups of 5 students in each group. Post test and assessment will be conducted after simulation based training and feedback will be collected in the form of questionnaire. In next session simulation based training of cardiac auscultation will be done in Group A and respiratory auscultation will be done in Group B. Post-test and assessment will be conducted and clinical skills will be evaluated on validated checklist.

Data collection: Data will be collected as validated Pre and post test checklists and scenario based assessment on simulators. Feedback will be collected from students in form of questionnaire and feedback from faculty will be taken in focused group discussions.

Data Analysis: Statistical analysis of quantitative data will be done by comparing pre and post test scores using SPSS 26th version. Qualitative data will be analyzed by thematic analysis.

Short term outcomes: First year medical students will be competent in respiratory auscultation and cardiac auscultation. Medical students will be more confident in performing auscultatory examination of respiratory and cardiovascular system on patients. Medical students will show enhanced psychomotor and cognitive skills.

Long term outcomes: Medical students will be competent to perform clinical examination and interpretation of auscultatory abnormalities independently as physician of primary contact.

 

 
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