Catheter-Associated Urinary Tract InfectionCAUTI-VSGNCT05309317
Preventing Catheter-Associated Urinary Tract Infections With a Virtual Simulation Game
A study testing Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections and Ongoing education in people with Catheter-Associated Urinary Tract Infection and Nurse's Role, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The purpose of this study was to investigate the effectiveness of a virtual simulation game in improving nursing students' knowledge and abilities in preventing catheter-associated urinary tract infection (CAUTI). Method: The study was designed as a parallel-group, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter-Associated Urinary Tract Infection, Nurse's Role
- What is being tested?
- Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections and Ongoing education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2022to 25 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be enrolled in Nursing Profession Courses Practice-II for the first time
- To agree to participate in the study
- To have internet access and smartphone or computer
Who cannot join
- Not filling in the data collection forms of the research at any stage
- Answering the data collection forms of the research incomplete
- Not having received the first or last skill assessments
- Not attending the training on preventing CAUTI
- Not playing/completing the virtual simulation game
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Simulation Game on Improving Nursing Students' Knowledge and Skills Regarding Prevention of Catheter- Associated Urinary Tract Infection
Objective: The purpose of this study was to investigate the effectiveness of a virtual simulation game in improving nursing students' knowledge and abilities in preventing catheter-associated urinary tract infection (CAUTI).
Method: The study was designed as a parallel-group, randomized controlled trial. A pre-test on knowledge and abilities will be administered to all students participating in the study. Following the pre-test evaluation, a training session on "CAUTI Prevention" will be held. The present training approach (lecture method) in the curriculum will be employed in this session. Following the training, the students in the sample group will be randomly divided into the experimental group (students using virtual simulation game application) and the control group (students learning with the existing education method) based on their general weighted grade averages using the stratified randomized approach. The experimental group will play the virtual simulation game for seven days. Knowledge and competence assessments (post-test) of the control and experimental groups will be conducted seven days following the training. The virtual simulation game application will be evaluated by the students in the experimental group after the post-test evaluations. The students' positive, negative, and constructive feedback on the virtual simulation game will be solicited during the assessment. In addition, these students will score in a 5-point Likert type to evaluate the statements about the virtual simulation game.
Read more
Hypothesis: H0-1: There is no difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.
H1-1: There is a difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.
H0-2: There is no difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.
H1-2: There is a difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.
- Being tested
- Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections, Ongoing education
- Keywords
- Virtual Simulation Game, Catheter-Associated Urinary Tract Infection, Nursing Education, Nursing Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract InfectionsOther
A training on "Prevention of CAUTI" will be held for the experimental and control groups. The experimental group will be able to play a seven-day virtual simulation game devised by the researcher to prevent CAUTI.
Ongoing educationOther
Only a course on "Prevention of CAUTI" will be given to the control group.
| Study group | Role | What they receive |
|---|---|---|
| CAUTI-VSG | Experimental | Preventing Catheter-Associated Urinary Tract Infections with a Virtual Simulation Game Receives: Other: Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections; Other: Ongoing education |
| Control group | Active comparator | Training on "CAUTI Prevention" Receives: Other: Ongoing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level
The investigator developed the "Knowledge Test on Preventing Catheter-Associated Urinary Tract Infection." There are 25 multiple-choice questions with five options on the test. The response to each question in the knowledge test will be scored out of 100 points, with 4 points being awarded for each correct answer. The overall score is based on a scale of 0 to 100. Higher scores imply that the student has a higher degree of knowledge.
Measured: Change from students' knowledge levels at seven days
Skill level
The investigator developed the "Skills Assessment Checklist for Preventing Catheter-Associated Urinary Tract Infection." Emptying the collecting bag, mobilization, specimen collection, and removal of the urine catheter of the patient are the parts of the competency evaluation checklist. The stages on the skill evaluation checklist will be scored as "Applied" (3 points), "Partly Applied (Incorrect)" (2 points), "Partly Applied (Missing)" (2 points), and "Not Applied" (3 points) (1 point). The collecting bag emptying checklist has 13 steps (minimum 13, maximum 39 points), the mobilization checklist has 8 steps (minimum 8, maximum 24 points), the specimen collection checklist has 22 steps (minimum 22, maximum 66 points), and the urinary catheter removal checklist has 13 steps (minimum 22, maximum 66 points) (minimum 13, maximum 39 points). Higher scores imply that the student's skill level is improving.
Measured: Change from students' skill levels at seven days
Secondary outcomes (1)
Opinions of the experimental group about the virtual simulation game
The Virtual Simulation Game Application Evaluation Form is divided into two sections. Three open-ended questions regarding the virtual simulation game are asked in the first section (What are your positive thoughts about the virtual simulation game?, What are your negative thoughts about the virtual simulation game?, What are your suggestions about the virtual simulation game?) The Virtual Simulation Game Technology Acceptance Questionnaire (SSO-TKA) is included in the second section, and it was created using the Technology Acceptance Model as a guide. The SSO-TKA contains 21 items that are used to assess the game's ease of use (applicability-15 items) and perceived utility (usability-6 items). Students will use a 5-point Likert scale to rate the items relevant to the virtual simulation game (1: Strongly disagree, 2: Disagree, 3: Undecided, 4: Agree, 5: Strongly Agree).
Measured: within 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start21 May 2022
- Primary completion28 May 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated Urinary Tract InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Mercan Annak, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309317
- Sponsor's protocol ID
- 57440
- Acronym
- CAUTI-VSG
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mercan Annak I, Bulut H. The Effect of Virtual Simulation Game on the Development of Nursing Students' Knowledge and Skills: A Randomized Controlled Trial. Nurs Open. 2026 May;13(5):e70566. doi: 10.1002/nop2.70566.
PubMed 42054480
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Simulation Game on Improving Nursing Students' Knowledge and Skills Regarding Prevention of Catheter- Associated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05309317
- Acronym / sponsor ID
- CAUTI-VSG / 57440
- Keywords
- Virtual Simulation Game, Catheter-Associated Urinary Tract Infection, Nursing Education, Nursing Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 21 May 2022 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 4 Apr 2022 (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.
Objective: The purpose of this study was to investigate the effectiveness of a virtual simulation game in improving nursing students' knowledge and abilities in preventing catheter-associated urinary tract infection (CAUTI).
Method: The study was designed as a parallel-group, randomized controlled trial. A pre-test on knowledge and abilities will be administered to all students participating in the study. Following the pre-test evaluation, a training session on "CAUTI Prevention" will be held. The present training approach (lecture method) in the curriculum will be employed in this session. Following the training, the students in the sample group will be randomly divided into the experimental group (students using virtual simulation game application) and the control group (students learning with the existing education method) based on their general weighted grade averages using the stratified randomized approach. The experimental group will play the virtual simulation game for seven days. Knowledge and competence assessments (post-test) of the control and experimental groups will be conducted seven days following the training. The virtual simulation game application will be evaluated by the students in the experimental group after the post-test evaluations. The students' positive, negative, and constructive feedback on the virtual simulation game will be solicited during the assessment. In addition, these students will score in a 5-point Likert type to evaluate the statements about the virtual simulation game.
Hypothesis: H0-1: There is no difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.
H1-1: There is a difference in knowledge about preventing CAUTI between students using the virtual simulation game method and students in the control group.
H0-2: There is no difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.
H1-2: There is a difference in CAUTI prevention skills between students using the virtual simulation game method and students in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAUTI-VSG | Experimental | Other: Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections, Other: Ongoing educationPreventing Catheter-Associated Urinary Tract Infections with a Virtual Simulation Game |
| Control group | Active comparator | Other: Ongoing educationTraining on "CAUTI Prevention" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be enrolled in Nursing Profession Courses Practice-II for the first time
- To agree to participate in the study
- To have internet access and smartphone or computer
Key exclusion criteria (5 listed)
- Not filling in the data collection forms of the research at any stage
- Answering the data collection forms of the research incomplete
- Not having received the first or last skill assessments
- Not attending the training on preventing CAUTI
- Not playing/completing the virtual simulation game
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 |
|---|---|---|
| Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract InfectionsA training on "Prevention of CAUTI" will be held for the experimental and control groups. The experimental group will be able to play a seven-day virtual simulation game devised by the researcher to prevent CAUTI. | Other | CAUTI-VSG |
| Ongoing educationOnly a course on "Prevention of CAUTI" will be given to the control group. | Other | CAUTI-VSG, Control group |
Primary outcome
Knowledge Level
Time frame: Change from students' knowledge levels at seven days
The investigator developed the "Knowledge Test on Preventing Catheter-Associated Urinary Tract Infection." There are 25 multiple-choice questions with five options on the test. The response to each question in the knowledge test will be scored out of 100 points, with 4 points being awarded for each correct answer. The overall score is based on a scale of 0 to 100. Higher scores imply that the student has a higher degree of knowledge.
Skill level
Time frame: Change from students' skill levels at seven days
The investigator developed the "Skills Assessment Checklist for Preventing Catheter-Associated Urinary Tract Infection." Emptying the collecting bag, mobilization, specimen collection, and removal of the urine catheter of the patient are the parts of the competency evaluation checklist. The stages on the skill evaluation checklist will be scored as "Applied" (3 points), "Partly Applied (Incorrect)" (2 points), "Partly Applied (Missing)" (2 points), and "Not Applied" (3 points) (1 point). The collecting bag emptying checklist has 13 steps (minimum 13, maximum 39 points), the mobilization checklist has 8 steps (minimum 8, maximum 24 points), the specimen collection checklist has 22 steps (minimum 22, maximum 66 points), and the urinary catheter removal checklist has 13 steps (minimum 22, maximum 66 points) (minimum 13, maximum 39 points). Higher scores imply that the student's skill level is improving.
1 secondary outcome
Opinions of the experimental group about the virtual simulation game
Time frame: within 1 week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 42054480Mercan Annak I, Bulut H. The Effect of Virtual Simulation Game on the Development of Nursing Students' Knowledge and Skills: A Randomized Controlled Trial. Nurs Open. 2026 May;13(5):e70566. doi: 10.1002/nop2.70566.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Simulation Game for the Prevention of Catheter-Associated Urinary Tract Infections and Ongoing education in people with Catheter-Associated Urinary Tract Infection and Nurse's Role, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge Level (time frame: Change from students' knowledge levels at seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309317, which also lists 1 linked publication.
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 1 Mar 2024.