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CTRI Number  CTRI/2023/05/052564 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Teaching Training (SIMULATION VERSUS DEMONSTRATION on Psychomotor skills on selected procedure) ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   “Evaluate the effectiveness of simulation versus demonstration on psychomotor skills. 
Scientific Title of Study   “Randomized controlled trial to evaluate the effectiveness of simulation versus demonstration on psychomotor skills among undergraduate BSc Nursing Students College of Nursing, IMS, BHU”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajendra Kumar jinjwaria  
Designation  Nursing Officer 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
College of Nursing ,IMS BHU.
Varanasi
UTTAR PRADESH
221005
India 
Phone  8871206912  
Fax    
Email  rajendra4137@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Kumar 
Designation  Professor 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Department of CTVS, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI. pin 221005
Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI. pin 221005
Varanasi
UTTAR PRADESH
221005
India 
Phone  9340858699  
Fax    
Email  kapuriyasaroj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rajendra kumar jinjwaria  
Designation  Nursing Officer 
Affiliation  BANARAS HINDU UNIVERSITY 
Address  Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Cardiothoracic ICU, Sir Sunderlal Hospital, Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Varanasi
UTTAR PRADESH
221005
India 
Phone  8871206912  
Fax    
Email  rajendra4137@gmail.com  
 
Source of Monetary or Material Support  
College of Nursing, IMS, BHU Varanasi 
 
Primary Sponsor  
Name  Rajendra Kumar Jinjwaria 
Address  2nd Floor, department of CTVS, IMS, BHU. 
Type of Sponsor  Other [[Self]] 
 
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 Punam Pandey  College of Nursing, BHU  Frist floor room no 3, College of Nursing Institute of Medical Science, Banaras Hindu University, Lanka, VARANASI.
Varanasi
UTTAR PRADESH 		 9984613336

rajendra4137@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University, Institute Of Medical Sciences Varanasi India- 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  BSC NURSING STUDENT, COLLEGE OF NURSING, IMS, BHU, VARANASI 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  clear control group on IV cannulation and orotracheal suctioning  Common Lecture on IV Canulation among Clear control Group 3rd: - 1 Hour. Common Lecture on orotracheal suctioning among Clear control Group 3rd: - 1 Hour.  
Intervention  demonstration on IV cannulation and orotracheal suctioning  The total duration of simulation and practice is 38 days (lecture and practice and pre & post-test) B. Demonstration (Experimental Group 2nd): - Total 18 days. 1) Total duration for lecture: - 2 days: - (One day for 1 hour) Common Lecture on IV Cannulation among Experimental Group 2nd: - 1 Hour. Common Lecture on orotracheal suctioning among Experimental Group 2nd: - 1 Hour. 2)The total duration for the demonstration for explanation and assessment by the researcher, practice by the participant on a normal dummy after that on a patient on IV Cannulation: - 8 days. Each day 5 students. Every student 10 to 20 minutes. 1)The total duration for the demonstration for explanation and assessment by the researcher, practice by the participant on a normal dummy after that on a patient on orotracheal suctioning: - 8 days. Each day 5 students. Every student 10 to 20 minutes.  
Intervention  simulation and on IV cannulation and orotracheal suctioning  The total duration of simulation and practice is 38 days (lecture and practice and pre & post-test) A. Simulation (Experimental Group 1st): - Total 18 days. 1)Total duration for lecture: - 2 days: - (One day for 1 hour) Common Lecture on IV Cannulation among Experimental Group 1st: - 1 Hour. Common Lecture on orotracheal suctioning among Experimental Group 1st: - 1 Hour. 2)The total duration for the simulation for explanation and assessment by the researcher, practice by the participant on a simulator dummy after that on a patient on IV Cannulation: - 8 days. Each day 5 students Every student 10 to 20 minutes. 1)The total duration for the simulation for explanation and assessment by the researcher, practice by the participant on a simulator dummy after that on a patient on orotracheal suctioning: - 8 days. Each day 5 students. Every student 10 to 20 minutes.  
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  1st year & initially enrolled 2nd year BSc Nursing Students College of Nursing IMS BHU are subject to written informed consent. Able to understand Hindi / English language. 
 
ExclusionCriteria 
Details  Cognitive impairment. Systematic illness upper respiratory tract, fever, any communicable disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of interventions on psychomotor skills in both experimental and control groups.


 		 pre and post-test data collection (2 times) 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the effect of simulation versus demonstration on psychomotor skills.  pre and post-test data collection (2 times) 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2023 
Date of Study Completion (India) 28/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/02/2024 
Estimated Duration of Trial   Years="3"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rajendra4137@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-09-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 â€œAim of this study is to compare the effectiveness of simulation versus demonstration on psychomotor skills on IV canulation and orotracheal suctioning”.

 
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