| 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
|
|
|
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
|
|
|
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. |