Pressure UlcerNCT06353763
Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum
A study testing Immersive virtual reality learning program in people with Pressure Ulcer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Immersive virtual reality learning program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Students who had acquired the skill of caring pressure ulcers in advance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Immersive Virtual Reality Training Versus Traditional Teaching in Pressure Ulcers Care. A Randomized Controlled Pilot Study
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).
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- Immersive virtual reality learning program
- Keywords
- Virtual reality,
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality learning programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention. Virtual reality | Experimental | Immersive virtual reality learning program based on virtual reality glasses Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start24 Feb 2022
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Las Rosas-Salas, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353763
- Sponsor's protocol ID
- CV
- Status last verified
- Jan 2024
- First submitted
- 25 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality Training Versus Traditional Teaching in Pressure Ulcers Care. A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06353763
- Acronym / sponsor ID
- CV
- Conditions
- Pressure Ulcer
- Keywords
- Virtual reality,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention. Virtual reality | Experimental | Other: Immersive virtual reality learning programImmersive virtual reality learning program based on virtual reality glasses |
| Control group: Traditional teaching | No intervention | –Self learning theoretical lesson and traditional teaching with a task trainer, supervised by a teacher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Students who had acquired the skill of caring pressure ulcers in advance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive virtual reality learning programThe 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. | Other | Intervention. Virtual reality |
Primary outcome
Knowledge
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Pressure Ulcer
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Las Rosas-Salas principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality learning program in people with Pressure Ulcer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.