- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474181
Simulation-Based Training for Urinary Catheterization Skills in Nursing Students
The Effect of Two Different Simulation Methods on Nursing Students' Knowledge and Skills in Urinary Catheter Application: A Randomised Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Healthcare-associated infections remain a significant challenge in modern healthcare systems, and catheter-associated urinary tract infections constitute an important portion of these complications. Proper urinary catheterization technique is essential for preventing infection, ensuring patient safety, and maintaining high-quality nursing care. Nursing education therefore requires effective teaching strategies that allow students to acquire both theoretical knowledge and psychomotor skills in a safe learning environment.
Simulation-based education has become an important approach in nursing training because it allows students to practice clinical procedures without risk to patients. Different simulation methods are currently used, including low-fidelity simulators, partial task trainers, and hybrid simulation approaches that combine standardized scenarios with procedural training. However, limited evidence exists regarding which simulation method provides better outcomes in terms of knowledge acquisition and procedural competence.
The present study is designed as a randomized controlled educational trial to compare the effectiveness of two simulation-based teaching approaches in urinary catheterization training among nursing students. The study will be conducted in the nursing simulation laboratory of Marmara University Faculty of Health Sciences. First-year nursing students will be recruited and randomly assigned into two parallel groups.
Participants in the control group will receive theoretical instruction followed by traditional simulation training using partial task trainers. Participants in the experimental group will receive the same theoretical instruction but will be trained using a hybrid simulation approach that integrates scenario-based learning with procedural simulation. Random allocation will be performed using computer-based randomization.
Data will be collected using multiple validated assessment tools. Knowledge regarding urinary catheterization will be measured using a structured knowledge test. Practical performance will be evaluated through an observational skill checklist during simulation practice. Additional outcomes include urinary catheterization competency, student satisfaction, learning self-confidence, and communication skills.
The collected data will be analyzed to compare educational outcomes between the two groups. The results are expected to provide evidence on the effectiveness of hybrid simulation methods in improving nursing students' knowledge and clinical skills in urinary catheterization training. The findings may contribute to improving simulation-based nursing education and enhancing patient safety through better clinical skill preparation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Özer, PhD(c)
- Phone Number: +902124984424 +905514042136
- Email: esraozer92@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Taking the Fundamentals of Nursing course
- Not having prior clinical experience
- Not having prior experience with urinary catheterization
- Not having received prior training in the field of health sciences (e.g., graduate of a health vocational high school, health services vocational college, etc.)
- Accepts Healthy Volunteers has not been entered.
Exclusion Criteria:
- Students who did not complete the research data collection forms
- Students who did not complete the simulation experiences
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arm
Hybrid Simulation Training
|
Experimental Group (Hybrid Simulation Method): Following theoretical training, students in the experimental group will be divided into small groups of five for a scenario-based hybrid simulation session.
In this session, a person playing the role of a simulated patient (e.g., a trained standardized patient or instructor) will have the developed wearable urinary catheter model inserted into its anatomical position.
The simulation scenario is designed to reflect a real clinical situation.
|
|
Active Comparator: Control Group
Partial Task Trainer-Based Simulation
|
Control Group (Traditional Method): Immediately following theoretical training, students in the control group will receive skills training in a laboratory setting using a demonstration method with a partial task instructor.
The instructor will demonstrate the urinary catheter insertion procedure on a mannequin; then each student will practice individually on the mannequin for 10-15 minutes.
Each student will be given a total of three catheter insertion attempts to reinforce the skill.
Throughout this process, the instructor will provide necessary corrective feedback.
Since this group focuses solely on technical skills without interaction with a real patient, they will be evaluated at the end of the training using a knowledge test, a skills checklist, and a competency scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observation Form for Urinary Catheter Insertion Skills (UCIS Observation Form)
Time Frame: During Catheterization Procedure
|
This is a three-point Likert-type observation checklist developed to objectively evaluate catheter placement skills in male patients.
The form consists of 29 critical steps determined through a literature review and based on evidence.
Each step is scored as follows: correct application is worth 2 points, partial application is worth 1 point, and failure to complete is worth 0 points.
Therefore, the minimum score on the form is 0, and the maximum score is 58.
An increase in the score indicates a better performance of the skill.
|
During Catheterization Procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Information Form (PIF)
Time Frame: baseline
|
Prepared by the researcher based on the literature, this form consists of questions containing demographic and educational information about the students, such as their age, gender, GPA, perception of the nursing profession, and whether they have previously received simulation training.
The form comprises a total of 8 questions.
|
baseline
|
|
Urinary Catheter Insertion Knowledge Test (UCI-KT)
Time Frame: baseline/within 10 minutes after urinary catheter insertion
|
This is a multiple-choice knowledge test created by a researcher to measure students' theoretical knowledge level regarding urinary catheterization.
The questions were developed based on relevant literature and educational content, aligning with the six cognitive levels of the original Bloom Taxonomy.
The test draft will be submitted for expert review and evaluated for content validity by at least eight academics.
Each correct answer is worth 1 point, and an incorrect answer is worth 0 points.
Higher scores indicate higher knowledge levels.
|
baseline/within 10 minutes after urinary catheter insertion
|
|
Urinary Catheterization Competency Scale (UCCS)
Time Frame: baseline/within 10 minutes after urinary catheter insertion
|
This is a measurement tool developed to assess nurses' knowledge, skills, and clinical management competencies regarding urinary catheterization.
The scale was developed by the researcher.
Initially, a pool of items was created using the literature.
A total of 26 items were prepared using a 4-point Likert scale (1: Strongly Disagree, 4: Strongly Agree).
It includes sub-dimensions of Knowledge and Awareness Level, Application Skills, and Clinical Management and Decision Making.
The highest possible score is 104, and the lowest is 26.
Higher scores indicate greater competence in urinary catheterization.
|
baseline/within 10 minutes after urinary catheter insertion
|
|
Student Satisfaction and Self-Confidence in Learning Scale (SSCL)
Time Frame: within 10 minutes after urinary catheter insertion
|
This scale was developed in 2006 by the National Nursing Association (NLN) to assess nursing students' attitudes toward learning through simulation, their satisfaction with instruction, and their self-confidence.
The scale consists of 13 items and includes two sub-dimensions: Satisfaction with Learning and Self-Confidence in Learning.
Item 13 is scored in reverse.
The response options are "5=Strongly agree, 4=Agree, 3=Undecided, 2=Disagree, 1=Strongly disagree".
The highest possible score on the scale is 65, and the lowest is 13.
As the scale score increases, satisfaction with learning and self-confidence increase.
|
within 10 minutes after urinary catheter insertion
|
|
Healthcare Professionals Communication Skills Scale (HP-CSS)
Time Frame: within 10 minutes after urinary catheter insertion
|
The scale was developed by Costa et al. in 2016.
The Turkish validity and reliability study of the scale was conducted by Mendi et al. in 2020.
This scale consists of 17 items and is divided into four dimensions: empathy (five items), informative communication (six items), respect (three items), and social skills (four items).
Participants rated each item on a Likert scale ranging from 1 to 6, indicating how often it was valid for them.
The highest possible score on the scale is 102, and the lowest is 16.
Higher scores indicate that healthcare professionals possess stronger communication skills.
|
within 10 minutes after urinary catheter insertion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MU-HEM-EÖ- 09.2025.25-0257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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