Nurse's RoleNCT06747286
Virtual Game Simulation in Patient Safety
A study testing Virtual Game Simulation in people with Nurse's Role, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
With the development of technology, virtual game simulation is starting to take an important place in nursing education, which has spread to the virtual world. There are studies conducted with this application, but there are no virtual game simulation studies related to patient safety. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Virtual Game Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 30 Jun 2025
- 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having taken the Fundamentals of Nursing course,
- Being willing and eager to participate in the study,
- Completing the Data Collection Forms completely,
- Not having any communication problems related to vision or hearing,
- Completing all stages of the simulation training process.
Who cannot join
- Not having received simulation training regarding patient safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Health Sciences University Hamidiye Faculty of Nursing
Istanbul
Semra AÇIKSÖZ, Assist Prof, (0216) 777 87 77, semra.aciksoz@sbu.edu.tr
About this study
Official title: The Effectiveness of Virtual Game Simulation Method Designed for Patient Safety in Nursing Students
With the development of technology, virtual game simulation is starting to take an important place in nursing education, which has spread to the virtual world. There are studies conducted with this application, but there are no virtual game simulation studies related to patient safety. The planned study aims to measure nursing students' tendencies and attitudes towards medical errors, satisfaction and self-confidence in nursing practices with a virtual game simulation related to patient safety developed by the researcher.
Read the detailed description
Simulation, also defined as activities that imitate clinical practices and simulation, are applications that provide competency-based clinical experience in a realistic environment that does not carry the risk of the real situation and is of great importance in terms of patient safety. Virtual game simulation, which includes technology and is one of the simulation applications, is a two-dimensional virtual computer game that includes simulated real people and allows students to actively participate in a clinical scenario. While the use of virtual game simulation in nursing education increases students' critical thinking, decision-making and problem-solving skills, it also provides learning by making mistakes and correcting mistakes by increasing individual development. The use of virtual game simulation in nursing education is necessary and important in ensuring and protecting patient safety. Virtual games, whose main purpose is to learn, have the potential to increase student participation, role-play difficult situations, try new reactions or work on creative solutions.
- Conditions
- Nurse's Role
- Being tested
- Virtual Game Simulation
- Keywords
- Virtual Game Simulation, Nursing Education, Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Game SimulationOther
Also called experimental
A virtual computer game that enables participation in a clinical scenario to measure competence.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | Group to be applied virtual game simulation Receives: Other: Virtual Game Simulation |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Student Information Form
The structured student information form, developed by the researcher in line with literature knowledge, includes a total of 13 questions on topics such as students' age, gender, etc.
Measured: one month
Modified Simulation Effectiveness Tool
The measurement tool for students' perceptions of the effectiveness of learning in a simulation environment was designed for self-reporting. The measurement tool has 19 items and four sub-dimensions. It is a 3-point Likert-type scale where the items are scored from 1 to 3. Scored as 1 - "Disagree", 2 - "Partially Agree", 3 - "Strongly Agree". The Cronbach Alpha internal consistency coefficient of the measurement tool is 0.93; the Cronbach Alpha coefficients of its sub-dimensions are 0.83, 0.85, 0.91 and 0.90, respectively. The total score is obtained by summing up all sub-dimension scores.
Measured: one month
Simulation Design Scale
The scale consists of 20 items and five subscales: "Goals and Information", "Support", "Problem Solving", "Feedback/Guided Reflection", and "Authenticity". The scale consists of two parts. The first part measures whether the best simulation design elements were applied in the simulation application. This section includes the statements "Strongly Disagree", "Disagree", "Undecided", "Agree", "Strongly Agree", and "Not Appropriate". The second part measures how important the simulation application is for the students. This section includes the statements "Not Important", "Partially Important", "Undecided", "Important", and "Very Important". Cronbach's Alpha values for the subheadings vary between 0.73 and 0.86. The score range is determined as 1 point being the lowest and 5 points being the highest. The scale is scored by dividing the total score given to the answers by the number of items.
Measured: one month
Student Satisfaction and Learning Self-Confidence Scale
It consists of two sub-dimensions, "satisfaction with learning" and "self-confidence", and a total of 13 items. The 13th item in the scale is reverse coded. The answer options are 5= Strongly agree, 4= Agree, 3= Undecided: Neither agree nor disagree, 2= Disagree, 1= Strongly disagree. The score is obtained from the sum of the items in the scale. The highest score that can be obtained from the scale is 65, the lowest score is 13. The internal consistency coefficient of the scale was found to be 0.94.
Measured: one month
Medical Error Scale for Nursing Students
The scale was prepared in a 5-point Likert type consisting of 36 items and 7 sub-dimensions, evaluated as always (5), usually (4), sometimes (3), rarely (2), never (1). The total score range of the scale is between 36 and 180. Scores close to 180 on the scale indicate that student nurses are controlled or careful regarding medical errors, while scores close to 36 indicate that student nurses are not controlled regarding medical errors or may make medical errors.
Measured: one month
Attitude Scale on Medical Errors
The scale consists of 16 items and 3 sub-dimensions. The aim of the scale is to examine the attitudes of healthcare professionals towards medical errors. It has 3 sub-headings: medical error perception (2 items), medical error approach (7 items), and reasons for medical errors (7 items). The scale is a five-point Likert-type scale. The scores of the answers to the items range from (1) I completely disagree to (5) I completely agree. Questions 10 and 13 under the sub-heading of medical error approach are reverse scored. The cut-off point of the scale is determined as 3. In the scale calculation, the total scale score is obtained by dividing the scale item number. In the sub-dimension calculation, the total score of the sub-dimension is divided by the number of items related to the relevant sub-dimension. The obtained score is between 1 and 5.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start30 Mar 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Two groups with an experiment control group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Avan Çınar, Saglik Bilimleri Universitesi
- Investigators
- Derya AVAN ÇINAR, Study Principal Investigator, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747286
- Sponsor's protocol ID
- SBU-SBEH-DAC-01
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Game Simulation Method Designed for Patient Safety in Nursing Students
- ClinicalTrials.gov ID
- NCT06747286
- Acronym / sponsor ID
- SBU-SBEH-DAC-01
- Conditions
- Nurse's Role
- Keywords
- Virtual Game Simulation, Nursing Education, Patient Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Dec 2024 (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.
With the development of technology, virtual game simulation is starting to take an important place in nursing education, which has spread to the virtual world. There are studies conducted with this application, but there are no virtual game simulation studies related to patient safety. The planned study aims to measure nursing students' tendencies and attitudes towards medical errors, satisfaction and self-confidence in nursing practices with a virtual game simulation related to patient safety developed by the researcher.
Detailed description
Simulation, also defined as activities that imitate clinical practices and simulation, are applications that provide competency-based clinical experience in a realistic environment that does not carry the risk of the real situation and is of great importance in terms of patient safety. Virtual game simulation, which includes technology and is one of the simulation applications, is a two-dimensional virtual computer game that includes simulated real people and allows students to actively participate in a clinical scenario. While the use of virtual game simulation in nursing education increases students' critical thinking, decision-making and problem-solving skills, it also provides learning by making mistakes and correcting mistakes by increasing individual development. The use of virtual game simulation in nursing education is necessary and important in ensuring and protecting patient safety. Virtual games, whose main purpose is to learn, have the potential to increase student participation, role-play difficult situations, try new reactions or work on creative solutions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with an experiment control group
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Other: Virtual Game SimulationGroup to be applied virtual game simulation |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Having taken the Fundamentals of Nursing course,
- Being willing and eager to participate in the study,
- Completing the Data Collection Forms completely,
- Not having any communication problems related to vision or hearing,
- Completing all stages of the simulation training process.
Key exclusion criteria (1 listed)
- Not having received simulation training regarding patient safety.
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 Game SimulationAlso: experimentalA virtual computer game that enables participation in a clinical scenario to measure competence. | Other | Experiment group |
Primary outcome
Structured Student Information Form
Time frame: one month
The structured student information form, developed by the researcher in line with literature knowledge, includes a total of 13 questions on topics such as students' age, gender, etc.
Modified Simulation Effectiveness Tool
Time frame: one month
The measurement tool for students' perceptions of the effectiveness of learning in a simulation environment was designed for self-reporting. The measurement tool has 19 items and four sub-dimensions. It is a 3-point Likert-type scale where the items are scored from 1 to 3. Scored as 1 - "Disagree", 2 - "Partially Agree", 3 - "Strongly Agree". The Cronbach Alpha internal consistency coefficient of the measurement tool is 0.93; the Cronbach Alpha coefficients of its sub-dimensions are 0.83, 0.85, 0.91 and 0.90, respectively. The total score is obtained by summing up all sub-dimension scores.
Simulation Design Scale
Time frame: one month
The scale consists of 20 items and five subscales: "Goals and Information", "Support", "Problem Solving", "Feedback/Guided Reflection", and "Authenticity". The scale consists of two parts. The first part measures whether the best simulation design elements were applied in the simulation application. This section includes the statements "Strongly Disagree", "Disagree", "Undecided", "Agree", "Strongly Agree", and "Not Appropriate". The second part measures how important the simulation application is for the students. This section includes the statements "Not Important", "Partially Important", "Undecided", "Important", and "Very Important". Cronbach's Alpha values for the subheadings vary between 0.73 and 0.86. The score range is determined as 1 point being the lowest and 5 points being the highest. The scale is scored by dividing the total score given to the answers by the number of items.
Student Satisfaction and Learning Self-Confidence Scale
Time frame: one month
It consists of two sub-dimensions, "satisfaction with learning" and "self-confidence", and a total of 13 items. The 13th item in the scale is reverse coded. The answer options are 5= Strongly agree, 4= Agree, 3= Undecided: Neither agree nor disagree, 2= Disagree, 1= Strongly disagree. The score is obtained from the sum of the items in the scale. The highest score that can be obtained from the scale is 65, the lowest score is 13. The internal consistency coefficient of the scale was found to be 0.94.
Medical Error Scale for Nursing Students
Time frame: one month
The scale was prepared in a 5-point Likert type consisting of 36 items and 7 sub-dimensions, evaluated as always (5), usually (4), sometimes (3), rarely (2), never (1). The total score range of the scale is between 36 and 180. Scores close to 180 on the scale indicate that student nurses are controlled or careful regarding medical errors, while scores close to 36 indicate that student nurses are not controlled regarding medical errors or may make medical errors.
Attitude Scale on Medical Errors
Time frame: one month
The scale consists of 16 items and 3 sub-dimensions. The aim of the scale is to examine the attitudes of healthcare professionals towards medical errors. It has 3 sub-headings: medical error perception (2 items), medical error approach (7 items), and reasons for medical errors (7 items). The scale is a five-point Likert-type scale. The scores of the answers to the items range from (1) I completely disagree to (5) I completely agree. Questions 10 and 13 under the sub-heading of medical error approach are reverse scored. The cut-off point of the scale is determined as 3. In the scale calculation, the total scale score is obtained by dividing the scale item number. In the sub-dimension calculation, the total score of the sub-dimension is divided by the number of items related to the relevant sub-dimension. The obtained score is between 1 and 5.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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.
Derya AVAN ÇINAR, Study Principal Investigator principal investigator
Saglik Bilimleri Universitesi
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 Game Simulation in people with Nurse's Role, run by Saglik Bilimleri Universitesi 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 5 inclusion and 1 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 27 Dec 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?
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 Semra Açıksöz, assist prof ((0216) 777 87 77, semra.aciksoz@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Student Information Form (time frame: one month). The study lists 6 primary outcomes in all. 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 27 Dec 2024.