Catheter-Related InfectionsNCT05710731
The Urinary Catheterization Training on Skills, Satisfaction and Self-Confidence in Nursing Students
A study testing Use of simulation in urinary catheterization training in people with Catheter-Related Infections and Urinary Catheterization, run by Cukurova University.
Trial summary
In our study, it is planned to use three different simulation methods. One of these; It is a low-reality simulator, a hip model. It is known that this model is used by many universities in nursing education today and is called the traditional method. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter-Related Infections, Urinary Catheterization
- What is being tested?
- Use of simulation in urinary catheterization training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2023to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To register for the Nursing Fundamentals II Course for the first time,
- Volunteering to participate in the research,
Who cannot join
- To be a graduate of Health Vocational High School,
- Working as a nurse/midwife
- Have any previous experience of urinary catheterization,
- Not attending the theoretical lesson,
- Not participating in demonstration and group work,
- Not participating in skill measurements
About this study
Official title: The Effects of Virtual Reality Simulation, Computer Based Simulation and Low Reality Simulation Methods Used in Urinary Catheterization Training on Skills, Satisfaction and Self-Confidence in Nursing Students
In our study, it is planned to use three different simulation methods. One of these; It is a low-reality simulator, a hip model. It is known that this model is used by many universities in nursing education today and is called the traditional method. Both of the other simulators the investigators will use are high-fidelity models. One of them is a computer-based full-body manikin and the other is a virtual reality simulation.
Read the detailed description
The research was designed as a randomized controlled experimental study to determine the effects of virtual reality simulation, computer-based simulation and low-reality simulation methods used in urinary catheterization training on skills, satisfaction and self-confidence in nursing students. The research will be carried out in Çukurova University Health Sciences Faculty Nursing Department Vocational Skills Laboratory in the spring semester of 2022-2023 academic year. The students who will participate in the research do not have clinical practice experience yet.
The computer-based simulation model (S550.100 Noelle, Gynecology Model) to be used in our study consists of the full human body and can produce real human sounds (pain response, fear, etc.). Thus, thanks to the computer connection, the communication between the student and the simulator is increased and the reality of the clinical environment is maintained. Person performing urinary catheterization on the simulator; can feel the resistance of structures such as urethra, sphincter and bladder, which are similar to the anatomical structure of the real patient. When the catheter enters the bladder, as in a real patient, artificial urine (yellow water) flows through the catheter and the catheter balloon can be fully inflated/deflated during catheter insertion/removal.
Considering the technical features of the virtual reality simulator, which is another simulator to be used in our study; Thanks to the glasses used, it is possible to say that the patient and hospital environment are presented to the students in 3D with high reality. With the use of glasses, students will be able to perform urinary catheterization with the joysticks they hold in their hands. Thanks to this technology, it is possible for students to evaluate themselves by facing situations that are difficult to control in real life, as if they are actually experiencing them, to gain the right knowledge and skills through the mistakes they have made, and to gain experience by developing their sense of confidence.
Another simulator to be used in the study is a low-reality hip model. This is a model used to gain the ability to apply urinary catheterization and only female external reproductive organs can be seen. While the catheter moves through the urinary system and enters the bladder, the feeling of resistance and pressure experienced on real patients cannot be experienced. After the catheter is integrated into the external reproductive organ, operations such as seeing its progress along the urethra and bladder, controlling its location and inflating the balloon cannot be performed. It is the traditional method used for urinary catheterization practice training of nursing students.
The sample size was calculated by Power analysis (G*Power 3.1.9.2) based on a similar study done before. Based on the results of students' self-confidence and satisfaction levels, a total of 156 samples were determined for each group with a test power of 0.80, 95% confidence (1-α) and an effect size of f=0.25, with a minimum of 53 samples. identified as a student. In the 2022-2023 academic year, the Department of Nursing enrolled 182 students in the first class. All students who meet the criteria to participate in the research will be assigned to one of the three simulation groups using simple random sampling method. Students will be listed taking into account the last three digits of the school number. The web address https://www.randomizer.org will be used for random assignment.
- Being tested
- Use of simulation in urinary catheterization training
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of simulation in urinary catheterization trainingOther
To train students on urinary catheterization by using one of 3 different simulation methods.
| Study group | Role | What they receive |
|---|---|---|
| low-reality simulation Group | Experimental | In this group, urinary catheterization will be performed through a plastic half-hip model. Receives: Other: Use of simulation in urinary catheterization training |
| Computer Based Simulation Group | Experimental | In this group, urinary catheterization will be performed through a computer-based full-body model. Receives: Other: Use of simulation in urinary catheterization training |
| Virtual Reality Simulation Group | Experimental | In this group, urinary catheterization will be performed through a software based on virtual reality technology. Receives: Other: Use of simulation in urinary catheterization training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Catheterization Practice Skills Evaluation
-Each student's urinary catheterization practice will be video-recorded one by one by the researcher, and then the videos will be watched and the "Urinary Catheterization Skills Checklist" will be filled.
Measured: 10 minutes
Secondary outcomes (1)
Student Satisfaction and Self Confidence Measurement
- At the end of the application, students will fill in the "Student Satisfaction and Self Confidence in Learning Scale".
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start14 Feb 2023 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion4 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, ECE KURT, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710731
- Sponsor's protocol ID
- Cukurova Ece Kurt SBF 01
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality Simulation, Computer Based Simulation and Low Reality Simulation Methods Used in Urinary Catheterization Training on Skills, Satisfaction and Self-Confidence in Nursing Students
- ClinicalTrials.gov ID
- NCT05710731
- Acronym / sponsor ID
- Cukurova Ece Kurt SBF 01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 14 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 4 Apr 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
In our study, it is planned to use three different simulation methods. One of these; It is a low-reality simulator, a hip model. It is known that this model is used by many universities in nursing education today and is called the traditional method. Both of the other simulators the investigators will use are high-fidelity models. One of them is a computer-based full-body manikin and the other is a virtual reality simulation.
Detailed description
The research was designed as a randomized controlled experimental study to determine the effects of virtual reality simulation, computer-based simulation and low-reality simulation methods used in urinary catheterization training on skills, satisfaction and self-confidence in nursing students. The research will be carried out in Çukurova University Health Sciences Faculty Nursing Department Vocational Skills Laboratory in the spring semester of 2022-2023 academic year. The students who will participate in the research do not have clinical practice experience yet.
The computer-based simulation model (S550.100 Noelle, Gynecology Model) to be used in our study consists of the full human body and can produce real human sounds (pain response, fear, etc.). Thus, thanks to the computer connection, the communication between the student and the simulator is increased and the reality of the clinical environment is maintained. Person performing urinary catheterization on the simulator; can feel the resistance of structures such as urethra, sphincter and bladder, which are similar to the anatomical structure of the real patient. When the catheter enters the bladder, as in a real patient, artificial urine (yellow water) flows through the catheter and the catheter balloon can be fully inflated/deflated during catheter insertion/removal.
Considering the technical features of the virtual reality simulator, which is another simulator to be used in our study; Thanks to the glasses used, it is possible to say that the patient and hospital environment are presented to the students in 3D with high reality. With the use of glasses, students will be able to perform urinary catheterization with the joysticks they hold in their hands. Thanks to this technology, it is possible for students to evaluate themselves by facing situations that are difficult to control in real life, as if they are actually experiencing them, to gain the right knowledge and skills through the mistakes they have made, and to gain experience by developing their sense of confidence.
Another simulator to be used in the study is a low-reality hip model. This is a model used to gain the ability to apply urinary catheterization and only female external reproductive organs can be seen. While the catheter moves through the urinary system and enters the bladder, the feeling of resistance and pressure experienced on real patients cannot be experienced. After the catheter is integrated into the external reproductive organ, operations such as seeing its progress along the urethra and bladder, controlling its location and inflating the balloon cannot be performed. It is the traditional method used for urinary catheterization practice training of nursing students.
The sample size was calculated by Power analysis (G*Power 3.1.9.2) based on a similar study done before. Based on the results of students' self-confidence and satisfaction levels, a total of 156 samples were determined for each group with a test power of 0.80, 95% confidence (1-α) and an effect size of f=0.25, with a minimum of 53 samples. identified as a student. In the 2022-2023 academic year, the Department of Nursing enrolled 182 students in the first class. All students who meet the criteria to participate in the research will be assigned to one of the three simulation groups using simple random sampling method. Students will be listed taking into account the last three digits of the school number. The web address https://www.randomizer.org will be used for random assignment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-reality simulation Group | Experimental | Other: Use of simulation in urinary catheterization trainingIn this group, urinary catheterization will be performed through a plastic half-hip model. |
| Computer Based Simulation Group | Experimental | Other: Use of simulation in urinary catheterization trainingIn this group, urinary catheterization will be performed through a computer-based full-body model. |
| Virtual Reality Simulation Group | Experimental | Other: Use of simulation in urinary catheterization trainingIn this group, urinary catheterization will be performed through a software based on virtual reality technology. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To register for the Nursing Fundamentals II Course for the first time,
- Volunteering to participate in the research,
Key exclusion criteria (6 listed)
- To be a graduate of Health Vocational High School,
- Working as a nurse/midwife
- Have any previous experience of urinary catheterization,
- Not attending the theoretical lesson,
- Not participating in demonstration and group work,
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 |
|---|---|---|
| Use of simulation in urinary catheterization trainingTo train students on urinary catheterization by using one of 3 different simulation methods. | Other | Computer Based Simulation Group, Virtual Reality Simulation Group, low-reality simulation Group |
Primary outcome
Urinary Catheterization Practice Skills Evaluation
Time frame: 10 minutes
-Each student's urinary catheterization practice will be video-recorded one by one by the researcher, and then the videos will be watched and the "Urinary Catheterization Skills Checklist" will be filled.
1 secondary outcome
Student Satisfaction and Self Confidence Measurement
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of simulation in urinary catheterization training in people with Catheter-Related Infections and Urinary Catheterization, run by Cukurova 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Catheterization Practice Skills Evaluation (time frame: 10 minutes). 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 2 Feb 2023.