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临床试验/NCT07310160
NCT07310160尚未招募不适用

Development of a Digital Twin-Haptic Integrated Mixed Reality Simulation for Pressure Injury Management

NEBAHAT BORA GÜNEŞ0 个研究点目标入组 130 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
130
主要终点
Pressure Injury Management Skill Level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Pressure Injury Management Skill Level

时间窗: 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

时间窗: 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.

次要结局

  • Perceived Learning in Pressure Injury Care(Pre-test, the day after intervention, 3-week follow-up)
  • Satisfaction and Self-Confidence in Pressure Injury Training(Pre-test, the day after intervention, 3-week follow-up)

研究者

发起方
NEBAHAT BORA GÜNEŞ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

NEBAHAT BORA GÜNEŞ

Assitant Professor

Hacettepe University

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