Pressure InjuryDT-HIMRSNCT07310160
Digital Twin-Haptic Integrated Mixed Reality Simulation
A study testing Digital Twin-Haptic Integrated Simulation and High-Fidelity Simulation in people with Pressure Injury and Simulation Based Learning, run by NEBAHAT BORA GÜNEŞ.
Trial summary
The responsibility for the management of pressure injuries belongs to nurses; the development of pressure injuries indicates that nursing care is not adequate. Pressure injury management should be addressed starting from undergraduate education in line with current guidelines. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Simulation Based Learning, Nursing
- What is being tested?
- Digital Twin-Haptic Integrated Simulation and High-Fidelity Simulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 29 May 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
- Nursing students enrolled in the Fundamentals of Nursing course.
- Students who achieved a score of 50 or higher in the Fundamentals of Nursing course.
- Students who voluntarily agree to participate in the study and provide informed consent.
Who cannot join
- Students with any communication barriers that may prevent participation or comprehension.
- Students with balance disorders (e.g., vertigo) or other medical conditions that could interfere with participation in the simulation.
- Students who fail to attend pre-test, post-test, or follow-up assessments.
- Students who do not participate in or complete the assigned simulation intervention.
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: Development of a Digital Twin-Haptic Integrated Mixed Reality Simulation for Pressure Injury Management
The responsibility for the management of pressure injuries belongs to nurses; the development of pressure injuries indicates that nursing care is not adequate. Pressure injury management should be addressed starting from undergraduate education in line with current guidelines. However, programs in which traditional education methods are used in pressure injury management are insufficient. Therefore, pressure injuries should be addressed with a structured simulation practice integrated with advanced technological methods. Any study using mixed reality in pressure injury management was not found in the literature. There is a study using augmented reality with a smartphone to measure wounds and a study examining the effectiveness of augmented reality in leg ulcer care. The use of mixed reality simulation in pressure injury management is one of the unique values of the project. Within the scope of the project, anchoring and monitoring physical objects in all application steps in pressure injury management and creating a digital twin is the most important original value of this project, which is that the student is immersed in the virtual reality environment in real-time and experiences all the processes physically-haptically. The digital twin-haptic integrated mixed reality simulation proposed in this project will contribute to the pressure injury literature and education by increasing the retention of information in memory and providing a realistic experience to the student, as it appeals to both visual, auditory, and tactile senses. The main aim of this project is to develop a digital twin-haptic integrated mixed reality simulation in pressure injury management and to compare the effect of the developed digital twin-haptic integrated mixed reality simulation and the high reality simulation in the institutional infrastructure on the students' knowledge level, skill performance, perceived learning level, satisfaction, and confidence level in learning. The project is planned as a randomized and comparative type and will last 24 months. A total of 130 second-year nursing undergraduate students will be stratified and randomized into the digital twin-haptic integrated mixed reality simulation and high-fidelity simulation groups based on their course grades and gender. Data will be collected using tests and scales. In terms of project management, the project has been handled in four phases with six work packages; in the first preparation phase, validity and reliability studies of the data collection tools, scenarios, and theoretical training module developed by the project team will be carried out, and participant randomization will be carried out. In the second phase, simulation laboratories will be prepared. In the third stage, the mixed-reality simulation software will be created and tested. In the last stage, pre-test application, training with the theoretical training module, simulation application, post-test, and follow-up will be carried out. Data will be analyzed using SPSS®23. All work to be carried out within the scope of the project is defined concretely and according to the workflow, and who/s will carry out each work is defined according to the field of expertise. All possible risks that may be encountered during the project have been foreseen, and measures for risk management have been prepared as Plan B. Within the scope of the project, importance was given to the use of the facilities, infrastructure, and equipment available in the institution. Within the scope of the project, the digital twin-haptic integrated mixed reality simulation will be developed entirely with national resources and registered. The mixed reality simulation software will be commercialized for educational purposes. In addition, with the use of the digital twin-haptic integrated mixed reality simulation program in the management of pressure injury, the quality of education in the field of health will increase, and the IT infrastructure of the training curricula will be supported, and a standard will be provided throughout the country, thus creating a sufficient and qualified workforce in this field. As a result of this qualified training, it is predicted that pressure injury rates will decrease and patient safety will increase in the long term. With the mixed reality simulation program, the leadership power of our country in the international arena, its potential, and recognition in the field of education and technology will be increased.
- Conditions
- Pressure Injury, Simulation Based Learning, Nursing
- Being tested
- Digital Twin-Haptic Integrated Simulation, High-Fidelity Simulation
- Keywords
- haptic, mixed reality, digital twin
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Twin-Haptic Integrated SimulationDevice
Participants perform pressure injury care procedures using a virtual reality simulation with a real-time digital twin and haptic feedback. Students wear VR headsets and interact with a digital model of the wound while performing physical actions such as wound assessment, cleansing, dressing, and patient repositioning. The digital twin mirrors each action to provide immediate visual and tactile feedback. This method allows students to practice clinical skills in a controlled environment, combining virtual and physical components. No brand-specific equipment names are used, and all activities follow established clinical guidelines.
High-Fidelity SimulationBehavioural
Participants perform pressure injury care on a high-fidelity manikin in a simulation laboratory. The structured scenario includes wound assessment, cleansing, application of cream, dressing, and patient repositioning. The simulation replicates clinical procedures in a controlled setting, allowing students to practice and apply theoretical knowledge to standard nursing care. No brand-specific equipment names are used, and all activities follow established clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Digital Twin Haptic Integrated Simulation Group | Experimental | Participants in the digital twin-haptic integrated simulation group will receive training on pressure injury management using a virtual reality environment integrated with real-time digital twin and haptic feedback technologies. Nursing students who scored above 50 in the Fundamentals of Nursing course will be included. Those with communication barriers or balance disorders (e.g., vertigo) will be excluded. Participants who miss pre-, post-, or follow-up tests or fail to complete the intervention will be withdrawn. The intervention aims to enhance clinical reasoning, spatial awareness, and psychomotor skills through immersive, interactive simulation. Receives: Device: Digital Twin-Haptic Integrated Simulation |
| High-Fidelity Simulation Group | Active comparator | Participants in the high-fidelity simulation group will engage in a pressure injury management training using the high-fidelity simulator (SimMan®) within the faculty's simulation laboratory. Nursing students who scored above 50 in the Fundamentals of Nursing course will be included. Those with communication barriers or balance disorders (e.g., vertigo) will be excluded. Participants who fail to attend pre-, post-, or follow-up tests or do not complete the simulation will be withdrawn. The intervention aims to improve clinical decision-making and psychomotor skills through realistic, hands-on simulation experience. Receives: Behavioral: High-Fidelity Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Injury Management Skill Level
Evaluates students' practical performances in pressure injury care, including wound assessment, cleansing, dressing, and patient repositioning with 6-item skill checklist based on NPIAP guidelines. Each item scored 0-1; total 0-6. Inter-rater reliability assessed via Kendall W coefficient.
Measured: Pre-test, the day after intervention, 3-week follow-up
Pressure Injury Management Knowledge Level
Measures students' cognitive knowledge of pressure injury management with 20-item multiple-choice test. Each correct answer scores 1 point; total score ranges from 0 to 20. Test items were reviewed for content validity by experts and item analysis was performed to ensure reliability.
Measured: Pre-test, the day after intervention, 3-week follow-up
Secondary outcomes (2)
Perceived Learning in Pressure Injury Care
Measures students' self-reported learning in cognitive, affective, and psychomotor domains specifically related to pressure injury care. with a 9-item Rovai Perceived Learning Scale (cognitive, affective, psychomotor subscales) 7-point Likert scale; higher scores indicate higher perceived learning.
Measured: Pre-test, the day after intervention, 3-week follow-up
Satisfaction and Self-Confidence in Pressure Injury Training
Assesses students' satisfaction with the pressure injury simulation (teaching methods, materials, facilitation) and their confidence in performing the learned skills, including wound care and clinical decision-making with 13-item NLN Student Satisfaction and Self-Confidence Scale. Items scored on 5-point Likert scale; higher scores indicate greater satisfaction and self-confidence.
Measured: Pre-test, the day after intervention, 3-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start2 Feb 2026 (estimated)
- Primary completion2 Feb 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEBAHAT BORA GÜNEŞ
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, NEBAHAT BORA GÜNEŞ, Hacettepe University
- Investigators
- Leyla Özdemir, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310160
- Sponsor's protocol ID
- 124S837
- Other IDs
- 124S834
- Acronym
- DT-HIMRS
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaylor J, Hooper V, Wilson A, Burkert R, Lyda M, Fletcher K, Bowers E. Reliability Testing of Augmented Reality Glasses Technology: Establishing the Evidence Base for Telewound Care. J Wound Ostomy Continence Nurs. 2019 Nov/Dec;46(6):485-490. doi: 10.1097/WON.0000000000000585.
PubMed 31633610Hoenig, W., Milanes, C., Scaria, L., Phan, T., Bolas, M., & Ayanian, N. (2015, September). Mixed reality for robotics. In 2015 IEEE/RSJ International Conference on Intelligent Robots and Systems (IROS) (pp. 5382-5387). IEEE.
Hauze SW, Hoyt HH, Frazee JP, Greiner PA, Marshall JM. Enhancing Nursing Education Through Affordable and Realistic Holographic Mixed Reality: The Virtual Standardized Patient for Clinical Simulation. Adv Exp Med Biol. 2019;1120:1-13. doi: 10.1007/978-3-030-06070-1_1.
PubMed 30919290Baratz G, Sridharan PS, Yong V, Tatsuoka C, Griswold MA, Wish-Baratz S. Comparing learning retention in medical students using mixed-reality to supplement dissection: a preliminary study. Int J Med Educ. 2022 Apr 29;13:107-114. doi: 10.5116/ijme.6250.0af8.
PubMed 35506483
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Twin-Haptic Integrated Mixed Reality Simulation for Pressure Injury Management
- ClinicalTrials.gov ID
- NCT07310160
- Acronym / sponsor ID
- DT-HIMRS / 124S837
- Conditions
- Pressure Injury, Simulation Based Learning, Nursing
- Keywords
- haptic, mixed reality, digital twin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- NEBAHAT BORA GÜNEŞUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 30 Dec 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 responsibility for the management of pressure injuries belongs to nurses; the development of pressure injuries indicates that nursing care is not adequate. Pressure injury management should be addressed starting from undergraduate education in line with current guidelines. However, programs in which traditional education methods are used in pressure injury management are insufficient. Therefore, pressure injuries should be addressed with a structured simulation practice integrated with advanced technological methods. Any study using mixed reality in pressure injury management was not found in the literature. There is a study using augmented reality with a smartphone to measure wounds and a study examining the effectiveness of augmented reality in leg ulcer care. The use of mixed reality simulation in pressure injury management is one of the unique values of the project. Within the scope of the project, anchoring and monitoring physical objects in all application steps in pressure injury management and creating a digital twin is the most important original value of this project, which is that the student is immersed in the virtual reality environment in real-time and experiences all the processes physically-haptically. The digital twin-haptic integrated mixed reality simulation proposed in this project will contribute to the pressure injury literature and education by increasing the retention of information in memory and providing a realistic experience to the student, as it appeals to both visual, auditory, and tactile senses. The main aim of this project is to develop a digital twin-haptic integrated mixed reality simulation in pressure injury management and to compare the effect of the developed digital twin-haptic integrated mixed reality simulation and the high reality simulation in the institutional infrastructure on the students' knowledge level, skill performance, perceived learning level, satisfaction, and confidence level in learning. The project is planned as a randomized and comparative type and will last 24 months. A total of 130 second-year nursing undergraduate students will be stratified and randomized into the digital twin-haptic integrated mixed reality simulation and high-fidelity simulation groups based on their course grades and gender. Data will be collected using tests and scales. In terms of project management, the project has been handled in four phases with six work packages; in the first preparation phase, validity and reliability studies of the data collection tools, scenarios, and theoretical training module developed by the project team will be carried out, and participant randomization will be carried out. In the second phase, simulation laboratories will be prepared. In the third stage, the mixed-reality simulation software will be created and tested. In the last stage, pre-test application, training with the theoretical training module, simulation application, post-test, and follow-up will be carried out. Data will be analyzed using SPSS®23. All work to be carried out within the scope of the project is defined concretely and according to the workflow, and who/s will carry out each work is defined according to the field of expertise. All possible risks that may be encountered during the project have been foreseen, and measures for risk management have been prepared as Plan B. Within the scope of the project, importance was given to the use of the facilities, infrastructure, and equipment available in the institution. Within the scope of the project, the digital twin-haptic integrated mixed reality simulation will be developed entirely with national resources and registered. The mixed reality simulation software will be commercialized for educational purposes. In addition, with the use of the digital twin-haptic integrated mixed reality simulation program in the management of pressure injury, the quality of education in the field of health will increase, and the IT infrastructure of the training curricula will be supported, and a standard will be provided throughout the country, thus creating a sufficient and qualified workforce in this field. As a result of this qualified training, it is predicted that pressure injury rates will decrease and patient safety will increase in the long term. With the mixed reality simulation program, the leadership power of our country in the international arena, its potential, and recognition in the field of education and technology will be increased.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Twin Haptic Integrated Simulation Group | Experimental | Device: Digital Twin-Haptic Integrated SimulationParticipants in the digital twin-haptic integrated simulation group will receive training on pressure injury management using a virtual reality environment integrated with real-time digital twin and haptic feedback technologies. Nursing students who scored above 50 in the Fundamentals of Nursing course will be included. Those with communication barriers or balance disorders (e.g., vertigo) will be excluded. Participants who miss pre-, post-, or follow-up tests or fail to complete the intervention will be withdrawn. The intervention aims to enhance clinical reasoning, spatial awareness, and psychomotor skills through immersive, interactive simulation. |
| High-Fidelity Simulation Group | Active comparator | Behavioral: High-Fidelity SimulationParticipants in the high-fidelity simulation group will engage in a pressure injury management training using the high-fidelity simulator (SimMan®) within the faculty's simulation laboratory. Nursing students who scored above 50 in the Fundamentals of Nursing course will be included. Those with communication barriers or balance disorders (e.g., vertigo) will be excluded. Participants who fail to attend pre-, post-, or follow-up tests or do not complete the simulation will be withdrawn. The intervention aims to improve clinical decision-making and psychomotor skills through realistic, hands-on simulation experience. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Nursing students enrolled in the Fundamentals of Nursing course.
- Students who achieved a score of 50 or higher in the Fundamentals of Nursing course.
- Students who voluntarily agree to participate in the study and provide informed consent.
Key exclusion criteria (4 listed)
- Students with any communication barriers that may prevent participation or comprehension.
- Students with balance disorders (e.g., vertigo) or other medical conditions that could interfere with participation in the simulation.
- Students who fail to attend pre-test, post-test, or follow-up assessments.
- Students who do not participate in or complete the assigned simulation intervention.
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 |
|---|---|---|
| Digital Twin-Haptic Integrated SimulationParticipants perform pressure injury care procedures using a virtual reality simulation with a real-time digital twin and haptic feedback. Students wear VR headsets and interact with a digital model of the wound while performing physical actions such as wound assessment, cleansing, dressing, and patient repositioning. The digital twin mirrors each action to provide immediate visual and tactile feedback. This method allows students to practice clinical skills in a controlled environment, combining virtual and physical components. No brand-specific equipment names are used, and all activities follow established clinical guidelines. | Device | Digital Twin Haptic Integrated Simulation Group |
| High-Fidelity SimulationParticipants perform pressure injury care on a high-fidelity manikin in a simulation laboratory. The structured scenario includes wound assessment, cleansing, application of cream, dressing, and patient repositioning. The simulation replicates clinical procedures in a controlled setting, allowing students to practice and apply theoretical knowledge to standard nursing care. No brand-specific equipment names are used, and all activities follow established clinical guidelines. | Behavioural | High-Fidelity Simulation Group |
Primary outcome
Pressure Injury Management Skill Level
Time frame: Pre-test, the day after intervention, 3-week follow-up
Evaluates students' practical performances in pressure injury care, including wound assessment, cleansing, dressing, and patient repositioning with 6-item skill checklist based on NPIAP guidelines. Each item scored 0-1; total 0-6. Inter-rater reliability assessed via Kendall W coefficient.
Pressure Injury Management Knowledge Level
Time frame: Pre-test, the day after intervention, 3-week follow-up
Measures students' cognitive knowledge of pressure injury management with 20-item multiple-choice test. Each correct answer scores 1 point; total score ranges from 0 to 20. Test items were reviewed for content validity by experts and item analysis was performed to ensure reliability.
2 secondary outcomes
Perceived Learning in Pressure Injury Care
Time frame: Pre-test, the day after intervention, 3-week follow-up
Satisfaction and Self-Confidence in Pressure Injury Training
Time frame: Pre-test, the day after intervention, 3-week follow-up
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 30 Dec 2025.
- Background: PubMed 31633610Kaylor J, Hooper V, Wilson A, Burkert R, Lyda M, Fletcher K, Bowers E. Reliability Testing of Augmented Reality Glasses Technology: Establishing the Evidence Base for Telewound Care. J Wound Ostomy Continence Nurs. 2019 Nov/Dec;46(6):485-490. doi: 10.1097/WON.0000000000000585.
- BackgroundHoenig, W., Milanes, C., Scaria, L., Phan, T., Bolas, M., & Ayanian, N. (2015, September). Mixed reality for robotics. In 2015 IEEE/RSJ International Conference on Intelligent Robots and Systems (IROS) (pp. 5382-5387). IEEE.
- Background: PubMed 30919290Hauze SW, Hoyt HH, Frazee JP, Greiner PA, Marshall JM. Enhancing Nursing Education Through Affordable and Realistic Holographic Mixed Reality: The Virtual Standardized Patient for Clinical Simulation. Adv Exp Med Biol. 2019;1120:1-13. doi: 10.1007/978-3-030-06070-1_1.
- Background: PubMed 35506483Baratz G, Sridharan PS, Yong V, Tatsuoka C, Griswold MA, Wish-Baratz S. Comparing learning retention in medical students using mixed-reality to supplement dissection: a preliminary study. Int J Med Educ. 2022 Apr 29;13:107-114. doi: 10.5116/ijme.6250.0af8.
- 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.
Leyla Özdemir principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Digital Twin-Haptic Integrated Simulation and High-Fidelity Simulation in people with Pressure Injury and Simulation Based Learning, run by NEBAHAT BORA GÜNEŞ.
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 30 Dec 2025. 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 NEBAHAT BORA GÜNEŞ (+905053865558, nebahatgunes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Injury Management Skill Level (time frame: Pre-test, the day after intervention, 3-week follow-up). 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 NCT07310160, which also lists 4 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 30 Dec 2025.