NursingVRNCT07175467
Development and Implementation Haptic VR Simulation
A study testing Haptic-asissted virtual simulation in people with Nursing and Skill Performance, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this experimental study is to increase objectivity in clinical decision-making and skill assessment of nursing students by using haptic-assisted virtual reality simulation, unlike imported products used in nursing education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing, Skill Performance, Virtual Reality
- What is being tested?
- Haptic-asissted virtual simulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students who have agreed to participate in the study,
- Students taking the Fundamentals of Nursing course for the first time,
- Students with no prior simulation experience
Who cannot join
- Students who do not meet the inclusion criteria,
- Students who do not complete the data collection forms in full,
- Students who are retaking the Fundamentals of Nursing course will be excluded from the study.
- Students who do not participate in the virtual reality application or laboratory application to be implemented during the study period, who are absent, or who wish to withdraw from the study will be excluded from the study during the follow-up period.
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
Sakarya University Faculty of Health Sciences
Sakarya, Serdivan, 54200
Ramazan Bozkurt, MSc, +902642956607, ramazanbozkurt@sakarya.edu.tr
Özlem Doğu, PhD, +902642953882, ozlemdogu@sakarya.edu.tr
About this study
Official title: Development and Implementation of a Multi-Skill, Haptic-Supported Virtual Reality Simulation for Nursing Students
The goal of this experimental study is to increase objectivity in clinical decision-making and skill assessment of nursing students by using haptic-assisted virtual reality simulation, unlike imported products used in nursing education.
Hypotheses:
Read more
H1: There is a difference between the total psychomotor skill levels of the intervention and control group students in all relevant skill applications.
H2: There is a difference between the clinical decision-making score averages of the intervention and control group students.
Researchers will compare the effects of haptic-assisted virtual simulation training on psychomotor skill levels and clinical decision-making scores in the intervention and control groups.
Participants will:
- Students who have agreed to participate in the study,
- Students taking the Fundamentals of Nursing course for the first time,
- Students with no prior simulation experience
- Conditions
- Nursing, Skill Performance, Virtual Reality, Simulation-based Training
- Being tested
- Haptic-asissted virtual simulation
- Keywords
- nursing, virtual reality, skills training, clinical decision making, haptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haptic-asissted virtual simulationOther
The virtual reality application will be developed using the Unity game engine. The VR simulation environment, which will progress through scenarios, will include taking vital signs, performing aspiration, performing a nasogastric catheterization, oxygen therapy, performing physical examinations, and performing subcutaneous injections.
| Study group | Role | What they receive |
|---|---|---|
| Haptic-assisted virtual reality | Experimental | The haptic-assisted virtual reality simulation developed for the intervention group will enable them to practice nursing skills. Receives: Other: Haptic-asissted virtual simulation |
| Control | No intervention | Classic nursing skills education with task trainer in the nursing skills laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Decision Making, Self-Confidence, and Anxiety Assessment in Nursing
This scale assesses nursing students' anxiety and self-confidence levels in clinical decision-making. Separate scores are obtained for self-confidence and anxiety from the scale, which consists of a total of 27 questions. Both the self-confidence and anxiety sections of the scale have three subscales: "Using resources to obtain information and listening carefully (13 questions)", "Using available information to identify the problem (7 questions)", and "Knowing and taking action (7 questions)". Higher scores on self-confidence and its subdimensions indicate increased levels of self-confidence in clinical decision-making among students. Low scores on the anxiety section and its subdimensions indicate low levels of anxiety in clinical decision-making. It is a six-point Likert-type scale. The lowest possible score on the self-confidence and anxiety sections is 27, and the highest possible score is 162.
Measured: 1 month
Knowledge Test
The Knowledge Test, prepared in line with the literature, consists of 20 questions. Each question will be scored with "1" point for a correct answer and "0" points for an incorrect answer. Questions covering all skill applications will be scored out of 100, with the total number of correct answers completing the score. The form was evaluated by ten experts in the field of Nursing Fundamentals outside of the study and finalized. The purpose of the expert opinion is to examine the items according to criteria such as whether the test measures behavior according to its structure, its comprehensibility in terms of language, whether there are scientific errors, grammatical errors, and the suitability of the items for the group to be applied to, and to make the necessary corrections.
Measured: 1 month
Performance evaluation
The performance report, which awards points out of 100, will include scoring for nursing interventions. Performance report scores range from 0 to 100; minimum score "0", maximum score "100". The performance report applied with the task trainer has been created to be identical to the virtual patient simulation performance report, and OSCE steps have been defined. The performance forms created will be evaluated by the researcher during the student's application. All students (intervention and control groups) will use the application at least once within the scope of the study. For the success assessment in the applications, the cutoff score is considered as follows: 50.00-59.99 is passing, 60.00-69.99 is average, 70.00-84.99 is good, and 85.00-100 is excellent. A higher score indicates higher performance.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NursingStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, özlem doğu, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175467
- Sponsor's protocol ID
- E-61923333-050.99-285112
- Acronym
- VR
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are plans to make the IPD and related data dictionaries available for use. Researchers may share the data upon request after the study is published.
Publications
White KA. Development and validation of a tool to measure self-confidence and anxiety in nursing students during clinical decision making. J Nurs Educ. 2014 Jan 1;53(1):14-22. doi: 10.3928/01484834-20131118-05. Epub 2013 Nov 18.
PubMed 24256004Park S, Hur HK, Chung C. Learning effects of virtual versus high-fidelity simulations in nursing students: a crossover comparison. BMC Nurs. 2022 Apr 27;21(1):100. doi: 10.1186/s12912-022-00878-2.
PubMed 35473614Butt, A. L., Kardong-Edgren, S., & Ellertson, A. (2018). Using game-based virtual reality with haptics for skill acquisition. Clinical Simulation in Nursing, 16, 25-32.
Sundler AJ, Pettersson A, Berglund M. Undergraduate nursing students' experiences when examining nursing skills in clinical simulation laboratories with high-fidelity patient simulators: A phenomenological research study. Nurse Educ Today. 2015 Dec;35(12):1257-61. doi: 10.1016/j.nedt.2015.04.008. Epub 2015 Apr 25.
PubMed 25943280Sanders, D. (2010). Comparing ability to complete simple tele-operated rescue or maintenance mobile-robot tasks with and without a sensor system. Sensor Review, 30(1), 40-50.
Kim, S. Y., Han, H. G., Kim, J. W., Lee, S., & Kim, T. W. (2017). A hand gesture recognition sensor using reflected impulses. IEEE Sensors Journal, 17(10), 2975-2976.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Multi-Skill, Haptic-Supported Virtual Reality Simulation for Nursing Students
- ClinicalTrials.gov ID
- NCT07175467
- Acronym / sponsor ID
- VR / E-61923333-050.99-285112
- Conditions
- Nursing, Skill Performance, Virtual Reality, Simulation-based Training
- Keywords
- nursing, virtual reality, skills training, clinical decision making, haptic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 16 Sep 2025 (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 goal of this experimental study is to increase objectivity in clinical decision-making and skill assessment of nursing students by using haptic-assisted virtual reality simulation, unlike imported products used in nursing education.
Hypotheses:
H1: There is a difference between the total psychomotor skill levels of the intervention and control group students in all relevant skill applications.
H2: There is a difference between the clinical decision-making score averages of the intervention and control group students.
Researchers will compare the effects of haptic-assisted virtual simulation training on psychomotor skill levels and clinical decision-making scores in the intervention and control groups.
Participants will:
- Students who have agreed to participate in the study,
- Students taking the Fundamentals of Nursing course for the first time,
- Students with no prior simulation experience
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haptic-assisted virtual reality | Experimental | Other: Haptic-asissted virtual simulationThe haptic-assisted virtual reality simulation developed for the intervention group will enable them to practice nursing skills. |
| Control | No intervention | –Classic nursing skills education with task trainer in the nursing skills laboratory. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Students who have agreed to participate in the study,
- Students taking the Fundamentals of Nursing course for the first time,
- Students with no prior simulation experience
Key exclusion criteria (4 listed)
- Students who do not meet the inclusion criteria,
- Students who do not complete the data collection forms in full,
- Students who are retaking the Fundamentals of Nursing course will be excluded from the study.
- Students who do not participate in the virtual reality application or laboratory application to be implemented during the study period, who are absent, or who wish to withdraw from the study will be excluded from the study during the follow-up period.
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 |
|---|---|---|
| Haptic-asissted virtual simulationThe virtual reality application will be developed using the Unity game engine. The VR simulation environment, which will progress through scenarios, will include taking vital signs, performing aspiration, performing a nasogastric catheterization, oxygen therapy, performing physical examinations, and performing subcutaneous injections. | Other | Haptic-assisted virtual reality |
Primary outcome
Clinical Decision Making, Self-Confidence, and Anxiety Assessment in Nursing
Time frame: 1 month
This scale assesses nursing students' anxiety and self-confidence levels in clinical decision-making. Separate scores are obtained for self-confidence and anxiety from the scale, which consists of a total of 27 questions. Both the self-confidence and anxiety sections of the scale have three subscales: "Using resources to obtain information and listening carefully (13 questions)", "Using available information to identify the problem (7 questions)", and "Knowing and taking action (7 questions)". Higher scores on self-confidence and its subdimensions indicate increased levels of self-confidence in clinical decision-making among students. Low scores on the anxiety section and its subdimensions indicate low levels of anxiety in clinical decision-making. It is a six-point Likert-type scale. The lowest possible score on the self-confidence and anxiety sections is 27, and the highest possible score is 162.
Knowledge Test
Time frame: 1 month
The Knowledge Test, prepared in line with the literature, consists of 20 questions. Each question will be scored with "1" point for a correct answer and "0" points for an incorrect answer. Questions covering all skill applications will be scored out of 100, with the total number of correct answers completing the score. The form was evaluated by ten experts in the field of Nursing Fundamentals outside of the study and finalized. The purpose of the expert opinion is to examine the items according to criteria such as whether the test measures behavior according to its structure, its comprehensibility in terms of language, whether there are scientific errors, grammatical errors, and the suitability of the items for the group to be applied to, and to make the necessary corrections.
Performance evaluation
Time frame: 1 month
The performance report, which awards points out of 100, will include scoring for nursing interventions. Performance report scores range from 0 to 100; minimum score "0", maximum score "100". The performance report applied with the task trainer has been created to be identical to the virtual patient simulation performance report, and OSCE steps have been defined. The performance forms created will be evaluated by the researcher during the student's application. All students (intervention and control groups) will use the application at least once within the scope of the study. For the success assessment in the applications, the cutoff score is considered as follows: 50.00-59.99 is passing, 60.00-69.99 is average, 70.00-84.99 is good, and 85.00-100 is excellent. A higher score indicates higher performance.
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 19 Sep 2025.
- Background: PubMed 24256004White KA. Development and validation of a tool to measure self-confidence and anxiety in nursing students during clinical decision making. J Nurs Educ. 2014 Jan 1;53(1):14-22. doi: 10.3928/01484834-20131118-05. Epub 2013 Nov 18.
- Background: PubMed 35473614Park S, Hur HK, Chung C. Learning effects of virtual versus high-fidelity simulations in nursing students: a crossover comparison. BMC Nurs. 2022 Apr 27;21(1):100. doi: 10.1186/s12912-022-00878-2.
- BackgroundButt, A. L., Kardong-Edgren, S., & Ellertson, A. (2018). Using game-based virtual reality with haptics for skill acquisition. Clinical Simulation in Nursing, 16, 25-32.
- Background: PubMed 25943280Sundler AJ, Pettersson A, Berglund M. Undergraduate nursing students' experiences when examining nursing skills in clinical simulation laboratories with high-fidelity patient simulators: A phenomenological research study. Nurse Educ Today. 2015 Dec;35(12):1257-61. doi: 10.1016/j.nedt.2015.04.008. Epub 2015 Apr 25.
- BackgroundSanders, D. (2010). Comparing ability to complete simple tele-operated rescue or maintenance mobile-robot tasks with and without a sensor system. Sensor Review, 30(1), 40-50.
- BackgroundKim, S. Y., Han, H. G., Kim, J. W., Lee, S., & Kim, T. W. (2017). A hand gesture recognition sensor using reflected impulses. IEEE Sensors Journal, 17(10), 2975-2976.
- Individual participant dataSharing planned: Yes. There are plans to make the IPD and related data dictionaries available for use. Researchers may share the data upon request after the study is published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haptic-asissted virtual simulation in people with Nursing and Skill Performance, run by Sakarya 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 4 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 19 Sep 2025. 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 Özlem Doğu, PhD (+902642953882, ozlemdogu@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Decision Making, Self-Confidence, and Anxiety Assessment in Nursing (time frame: 1 month). The study lists 3 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 NCT07175467, which also lists 6 linked publications.
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 19 Sep 2025.