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CTRI Number  CTRI/2024/04/066026 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Evaluation study on nurses using low-fidelity simulation model to lower rate of catheter associated urinary tract infection 
Scientific Title of Study   Evaluation of nursing skill enhancement using low fidelity simulation strategy to lower the rate of catheter associated urinary tract infection (CAUTI): A Quasi-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  Dr Anjali Namdeo Patond 
Designation  Assistant Professor 
Affiliation  Datta Meghe Institute of Higher Education Sawangi Meghe  
Address  Department of Microbiology, Jawaharlal Nehru Medical College, AVBRH campus DMIHER Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8600076279  
Fax    
Email  anjalipatond@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gargi Mudey 
Designation  Professor & Head of Microbiology  
Affiliation  Datta Meghe Institute of Higher Education Sawangi Meghe  
Address  Department of Microbiology, Jawaharlal Nehru Medical College, AVBRH campus DMIHER Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9860265849  
Fax    
Email  gargimudey@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gargi Mudey 
Designation  Professor & Head of Microbiology  
Affiliation  Datta Meghe Institute of Higher Education Sawangi Meghe  
Address  Department of Microbiology, Jawaharlal Nehru Medical College, AVBRH campus DMIHER Sawangi Meghe


MAHARASHTRA
442001
India 
Phone  9860265849  
Fax    
Email  gargimudey@hotmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Meghe Wardha India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjali Patond  Jawaharlal Nehru Medical College  Department of Microbiology Jawaharlal Nehru MedicalSawangi Meghe College, AVBRH campus, DMIHER
Wardha
MAHARASHTRA 
8600076279

anjalipatond@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Interactive lecture, demonstration on low fidelity mannequin, observation, pre and post-test questionnaire 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aseptic Insertion of Urinary Catheter including catheter care and hand hygiene  Nursing staff included. Demonstration of urinary catheter in mannequin using prior checklist.Pre-test will be taken at the start of study and post-test will be taken at the end of one month. Nurses asked to demonstrate procedure before and after demonstration . They will be evaluated using standarized checklist and standarized questionnaire. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Nursing staff included in bedside care of adult patients 
 
ExclusionCriteria 
Details  Nurses involved in Out patient care, paediatric and neonatal care 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in catherter care, catheter care bundle, hand hygiene approach  Assessment will be done at end of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improving knowledge and practices of nursing staff to improve urinary catheter care measured   4 months 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/07/2024 
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="0"
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  

In a quasi-experimental study including staff nurses, the assessment of nursing skill enhancement utilising a low-fidelity simulation technique to lower the risk of catheter-associated urinary tract infection (CAUTI) would be investigated. The study will concentrate on how nurses’ proficiency with procedures like urinary catheterization can be enhanced through the use of simulation training, especially with low-fidelity simulators. The study emphasised the value of simulation in improving clinical skill, boosting self-assurance, and lowering the possibility of iatrogenic consequences from procedures like catheterization. The study made clear how well low-fidelity simulation training works to boost nurses’ self-efficacy and confidence when it comes to providing nursing care for patients with urine retention. It enhanced patient safety and care quality by giving nurses a secure setting in which to frequently practise skills until mastery. It has been determined that employing simulation as a teaching method is appropriate for the nursing profession since it allows nurses to make mistakes and grow from them without worrying about endangering patients. Overall, the study will demonstrate the value of simulation in nursing education, especially when it comes to improving the clinical skills, competence, and confidence of nurses. Simulation training is essential for preparing nurses for the difficulties they may encounter in clinical settings because it provides a secure setting for repeated practice and skill improvement. This, in turn, improves patient outcomes and the quality of healthcare provided.

 

 
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