Nursing StudentsNCT07474181
Simulation-Based Training for Urinary Catheterization Skills in Nursing Students
A study testing Hybrid Simulation Training and Partial Task Trainer-Based Simulation in people with Nursing Students and Urinary Catheterization, run by Marmara University.
Trial summary
The purpose of this study is to comparatively evaluate the effectiveness of two different simulation-based training methods on nursing students' knowledge and skills regarding urinary catheterization in male patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Students, Urinary Catheterization
- What is being tested?
- Hybrid Simulation Training and Partial Task Trainer-Based Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Students who did not complete the research data collection forms
- Students who did not complete the simulation experiences
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Two Different Simulation Methods on Nursing Students' Knowledge and Skills in Urinary Catheter Application: A Randomised Controlled Study
The purpose of this study is to comparatively evaluate the effectiveness of two different simulation-based training methods on nursing students' knowledge and skills regarding urinary catheterization in male patients. Accordingly, the effects of hybrid simulation training using a wearable urinary catheter model on students' knowledge level, psychomotor skill acquisition, satisfaction, learning self-confidence, and communication skills will be revealed compared to standard training using traditional partial task instructional models.
Read the 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.
- Conditions
- Nursing Students, Urinary Catheterization
- Being tested
- Hybrid Simulation Training, Partial Task Trainer-Based Simulation
- Keywords
- urinary catheterization, nursing student, simulation based learning, clinical skills training, Randomized Controlled Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Simulation TrainingBehavioural
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.
Partial Task Trainer-Based SimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Hybrid Simulation Training Receives: Behavioral: Hybrid Simulation Training |
| Control Group | Active comparator | Partial Task Trainer-Based Simulation Receives: Behavioral: Partial Task Trainer-Based Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation Form for Urinary Catheter Insertion Skills (UCIS Observation Form)
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.
Measured: During Catheterization Procedure
Secondary outcomes (5)
Participant Information Form (PIF)
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.
Measured: baseline
Urinary Catheter Insertion Knowledge Test (UCI-KT)
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.
Measured: baseline/within 10 minutes after urinary catheter insertion
Urinary Catheterization Competency Scale (UCCS)
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.
Measured: baseline/within 10 minutes after urinary catheter insertion
Student Satisfaction and Self-Confidence in Learning Scale (SSCL)
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.
Measured: within 10 minutes after urinary catheter insertion
Healthcare Professionals Communication Skills Scale (HP-CSS)
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.
Measured: within 10 minutes after urinary catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare two groups: an experimental group and a control group. The experimental group will receive hybrid simulation training using a wearable urinary catheter model. The control group will receive low-level simulation training using traditional methods and partial task-teaching models. Both groups will be evaluated with pre- and post-training measurements, and the results between the groups will be compared.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Özer, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474181
- Sponsor's protocol ID
- MU-HEM-EÖ- 09.2025.25-0257
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Simulation Methods on Nursing Students' Knowledge and Skills in Urinary Catheter Application: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07474181
- Acronym / sponsor ID
- MU-HEM-EÖ- 09.2025.25-0257
- Conditions
- Nursing Students, Urinary Catheterization
- Keywords
- urinary catheterization, nursing student, simulation based learning, clinical skills training, Randomized Controlled Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to comparatively evaluate the effectiveness of two different simulation-based training methods on nursing students' knowledge and skills regarding urinary catheterization in male patients. Accordingly, the effects of hybrid simulation training using a wearable urinary catheter model on students' knowledge level, psychomotor skill acquisition, satisfaction, learning self-confidence, and communication skills will be revealed compared to standard training using traditional partial task instructional models.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will compare two groups: an experimental group and a control group. The experimental group will receive hybrid simulation training using a wearable urinary catheter model. The control group will receive low-level simulation training using traditional methods and partial task-teaching models. Both groups will be evaluated with pre- and post-training measurements, and the results between the groups will be compared.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Hybrid Simulation TrainingHybrid Simulation Training |
| Control Group | Active comparator | Behavioral: Partial Task Trainer-Based SimulationPartial Task Trainer-Based Simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Students who did not complete the research data collection forms
- Students who did not complete the simulation experiences
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Simulation TrainingExperimental 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. | Behavioural | Experimental Arm |
| Partial Task Trainer-Based SimulationControl 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. | Behavioural | Control Group |
Primary outcome
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.
5 secondary outcomes
Participant Information Form (PIF)
Time frame: baseline
Urinary Catheter Insertion Knowledge Test (UCI-KT)
Time frame: baseline/within 10 minutes after urinary catheter insertion
Urinary Catheterization Competency Scale (UCCS)
Time frame: 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
Healthcare Professionals Communication Skills Scale (HP-CSS)
Time frame: within 10 minutes after urinary catheter insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Simulation Training and Partial Task Trainer-Based Simulation in people with Nursing Students and Urinary Catheterization, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Özer, PhD(c) (+905514042136 ext. +902124984424, esraozer92@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation Form for Urinary Catheter Insertion Skills (UCIS Observation Form) (time frame: During Catheterization Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.