Clinical trial NCT06353763: Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum
Official title: Effectiveness of Immersive Virtual Reality Training Versus Traditional Teaching in Pressure Ulcers Care. A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Virtual reality,
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Knowledge
timeFrame: One month
measure: Skill performance
timeFrame: One month
measure: Usefulness, Satisfaction, and Ease of Use
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Virginia Las Rosas-Salas
role: PRINCIPAL_INVESTIGATOR
References: