Digital Twin-Haptic Integrated Mixed Reality Simulation

NCT ID: NCT07310160

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2026-05-29

Brief 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. 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

Keywords

haptic; mixed reality; digital twin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Digital Twin Haptic Integrated Simulation Group

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.

Group Type: EXPERIMENTAL

Digital Twin-Haptic Integrated Simulation

Intervention Type: DEVICE

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 Simulation Group

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.

Group Type: ACTIVE_COMPARATOR

High-Fidelity Simulation

Intervention Type: BEHAVIORAL

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.

Interventions

Digital Twin-Haptic Integrated Simulation

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.

Intervention Type: DEVICE

High-Fidelity Simulation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

NEBAHAT BORA GÜNEŞ

OTHER

Sponsor Role: lead

Responsible Party

NEBAHAT BORA GÜNEŞ

Assitant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leyla Özdemir

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Central Contacts

NEBAHAT BORA GÜNEŞ

Role: CONTACT

Phone: +905053865558

Email: nebahatgunes@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 31633610 (View on PubMed)

Hoenig, 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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 30919290 (View on PubMed)

Baratz 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.

Reference Type: BACKGROUND

PMID: 35506483 (View on PubMed)

Other Identifiers

124S834

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

124S837

Identifier Type: -

Identifier Source: org_study_id