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临床试验/NCT06353763
NCT06353763已完成不适用

Effectiveness of Immersive Virtual Reality Training Versus Traditional Teaching in Pressure Ulcers Care. A Randomized Controlled Pilot Study

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2022年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
Knowledge

研究概览

简要总结

The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.

The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire).

详细描述

The study was a prospective, randomized, double-blind controlled trial conducted from March to May 2022 at a Nursing Faculty. The participants were second-year Nursing Bachelor Degree students from a University in the North of Spain. A convenience sample of students in the second year of the nursing program participated in the study. According to the sample size calculation for a two-tailed independent t-test, conducted using the G*Power 3.1.9 program, with a type I error rate of 0.05, power of 0.80, and an effect size of 0.71, the estimated minimum required sample size was 33. The recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up. After registering to enrol in the study, 127 students were screened by the researchers for eligibility. Of these, 99 volunteers met the inclusion criteria and were contacted to schedule the pre-test phase. Following the pre-test assessment, participants were randomly assigned to either the intervention group (50 students) or the control group (49 students) at a 1:1 allocation ratio using a computer-generated assignment. During the study, three participants in the intervention group and two in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. In total, 93 participants were included in the data analysis.

Data was collected from February to May, a period during which the students did not have exams. The demographic information form included fields for age, gender, specific learning related to pressure ulcer care at degree level, and previous experience with virtual reality devices and environments.

研究设计

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

盲法说明

Participants were blinded in their group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Students enrolled in the 2rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study.

排除标准

  • Students who had acquired the skill of caring pressure ulcers in advance.

结局指标

主要结局

Knowledge

时间窗: One month

The Pressure Ulcer Knowledge Assessment Tool (PUKAT) 2.0 was used to evaluate students' understanding of caring for patients with pressure ulcer problems. The instrument was created and validated by Manderlier (2017). It consists of 25 multiple-choice items, each with a stem containing the problem and five response alternatives. The items are categorized into six relevant themes: 'Aetiology' (6 items), 'Classification and observation' (4 items), 'Risk assessment' (2 items), 'Nutrition' (3 items), 'Prevention of PU' (8 items), and 'Specific patient groups' (2 items). Each correct answer was awarded one point, with a total score of 25. Incorrect answers were not penalised. A higher score indicated a better understanding of PU prevention and care.

Skill performance

时间窗: One month

To assess procedural skill in pressure ulcers care, a simulation-based experience (SBE) with a standardized patient was created. The SBE consisted of six cases, each corresponding to one of the six levels of Immersive Virtual Reality (IVR) training, but with different images. Upon entering the classroom, the student had to choose one of six real images, face down, and turn it over to reveal the hazard for the experiment. The simulation-based experience should be completed within ten minutes using the knowledge acquired through self-learning and IVR training. This includes the use of tools such as the Braden scale or the T.I.M.E. (Tissue, infection, moisture, edges) clinical decision support tool to care for the level of pressure ulcers shown in the image. The SBE was evaluated using a 10-item rubric created by the research team and reviewed by a nurse specialist in chronic wounds and pressure ulcers.

Usefulness, Satisfaction, and Ease of Use

时间窗: One month

Usability refers to the ease of identifying, comprehending, and using something. To measure the usability and satisfaction of the glasses, we used the Usefulness, Satisfaction, and Ease of Use (USE) questionnaire developed by Lund (2001). The questionnaire assesses four dimensions: usefulness, ease of use, ease of learning, and satisfaction. The USE questionnaire consists of 30 items that assess usability on a 7-point Likert scale ranging from 1 (totally disagree) to 7 (totally agree). The questionnaire has good face validity, reliability, and validity due to its unambiguous and relevant descriptions.

次要结局

未报告次要终点

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (1)

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