NCT06353763

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

March 25, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

Virtual reality,

Outcome Measures

Primary Outcomes (3)

  • Knowledge

    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.

    One month

  • Skill performance

    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.

    One month

  • Usefulness, Satisfaction, and Ease of Use

    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.

    One month

Study Arms (2)

Intervention. Virtual reality

EXPERIMENTAL

Immersive virtual reality learning program based on virtual reality glasses

Other: Immersive virtual reality learning program

Control group: Traditional teaching

NO INTERVENTION

Self learning theoretical lesson and traditional teaching with a task trainer, supervised by a teacher.

Interventions

The immersive virtual reality learning programme was developed by the research team and two nurse experts in chronic wounds, who designed the learning content and script and created six pressure ulcer (PU) cases. Based on the standards of the European Pressure Ulcer Advisory Panel (EPUAP), the National Pressure Ulcer Advisory Panel (NPUAP) and the National Group for the Study and Advice on Pressure Ulcers and Chronic Wounds (GNEAUPP), prevention of healthy skin (case one), management of grade I, II, III and IV PUs (cases two to five) and an infected PU (debridement intervention) were developed. For each case, there was a formative version with immediate feedback and an evaluative one. Before starting the training, the students learned how to use the virtual reality glasses, buttons and joystick by playing a game that trained different dexterity movements. The computer assembly IVR application was developed using Unity 3D and the virtual objects were designed in 3Ds Max.

Intervention. Virtual reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Navarra

Pamplona, Navarre, Spain

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Virginia Las Rosas-Salas

    University of Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded in their group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 9, 2024

Study Start

February 24, 2022

Primary Completion

May 30, 2022

Study Completion

June 30, 2022

Last Updated

April 9, 2024

Record last verified: 2024-01

Locations