Informed ConsentUBUJIRV25NCT06839573
Effectiveness of Immersive Virtual Reality in Nursing Students' Learning
A study testing Experience with virtual reality glasses in people with Informed Consent, run by Universitat Jaume I.
Trial summary
Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent
- What is being tested?
- Experience with virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2025to 8 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having completed the scheduled in-person simulation in previous years of the degree .
Who cannot join
- -the student does not sign the informed consent to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marta Raurell-Torredà, phD contact
About this study
Official title: Effectiveness of Immersive Virtual Reality to Improve Learning Outcomes in Nursing Degree Students: A Randomized Clinical Trial
Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.
- Conditions
- Informed Consent
- Being tested
- Experience with virtual reality glasses
- Keywords
- Virtual reality, nursing students, Learning Outcomes, Inmersive virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience with virtual reality glassesOther
Also called Formative intervention
If the group belongs to GE (teaching with in-person simulation in the classroom and teaching with VR headsets), they will also receive the two training sessions described for GC:
30 minutes of individual training through VR (headsets and controllers to perform actions while receiving immediate feedback through VR) before the in-person simulation.
| Study group | Role | What they receive |
|---|---|---|
| RV INTERVENTION | Experimental | Experience with virtual reality glasses Receives: Other: Experience with virtual reality glasses |
| NON RV CONTROL | No intervention | Group Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the satisfaction
To compare the satisfaction acquired by students when performing basic cardiopulmonary resuscitation and patient examination between both teaching groups (experimental group - EG: VR plus in-person simulation, control group - CG: in-person simulation). We will mesure this with Satisfaction and Self-Confidence in Learning Scale (SCLS-Sp) (Farrés-Tarafa et al., 2021) .
Measured: Five months
Compare the self-confidence
To compare the self-confidence acquired by students when performing basic cardiopulmonary resuscitation and patient examination between both teaching groups (experimental group - EG: VR plus in-person simulation, control group - CG: in-person simulation). We will mesure this with Satisfaction and Self-Confidence in Learning Scale (SCLS-Sp) (Farrés-Tarafa et al., 2021) .
Measured: Five months
Secondary outcomes (5)
To compare the acquisition of knowledge in each teaching group.
We will use the Knowledge and Skills Checklist to perform basic CPR to measure. Adapted from European Resuscitation Council Guidelines (Perkins et al., 2021), with official translation into Spanish from the Spanish CPR Council and validated in the Boada study (Boada et al., 2015). CPR instructor faculty who does not participate in simulation-based teaching will evaluate the performance in situ of the group during the face-to-face simulation scenario.
Measured: Five months
To compare the acquisition of skills in each teaching group.
We will use the Knowledge and Skills Checklist to perform basic CPR to measure. Adapted from European Resuscitation Council Guidelines (Perkins et al., 2021), with official translation into Spanish from the Spanish CPR Council and validated in the Boada study (Boada et al., 2015). CPR instructor faculty who does not participate in simulation-based teaching will evaluate the performance in situ of the group during the face-to-face simulation scenario.
Measured: Five months
To evaluate students' tolerance to VR headset technology.
To measure this objective, we will use the Student Tolerance Scale for Teaching with VR Glasses used by Martí-Hereu (Martí-Hereu et al., 2024). Evaluate the presence of effects collaterals of the use of VR glasses with six items (nausea, dizziness drowsiness, headache, tranquility, well-being) using a scale Likert (never, rarely, sometimes, most of the time). It will be administered to the students individually at the end of teaching with the VR glasses in both teaching groups (GC after simulation in person; GE before the face-to-face simulation).
Measured: Five months
To assess the usability of VR headsets by students.
USE questionnaire to assess the usefulness, satisfaction and ease of use of a digital technology, developed by Gao (Gao et al., 2018) and adapted to the use of immersive VR glasses with health sciences professionals by Peek (Peek et al., 2023). Scale to assess affinity with technology (ATI scale), validated to our cultural context (Franke et al., 2019).
Measured: Five months
To analyze the costs of traditional teaching with in-person simulation compared to teaching with VR.
With all the results we will be able to analyze the cost-benefit of this new technology.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start5 Mar 2025 (estimated)
- Primary completion5 Mar 2025 (estimated)
- Study completion8 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies 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
- Model description
- Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Isabel Almodóvar Fernández, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839573
- Sponsor's protocol ID
- UB-UJI-RV25
- Acronym
- UBUJIRV25
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is multicenter, so it is already planned to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality to Improve Learning Outcomes in Nursing Degree Students: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06839573
- Acronym / sponsor ID
- UBUJIRV25 / UB-UJI-RV25
- Conditions
- Informed Consent
- Keywords
- Virtual reality, nursing students, Learning Outcomes, Inmersive virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- University of Barcelona, Universidad Complutense de Madrid
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 8 May 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.
| Arm | Type | Receives |
|---|---|---|
| RV INTERVENTION | Experimental | Other: Experience with virtual reality glassesExperience with virtual reality glasses |
| NON RV CONTROL | No intervention | –Group Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having completed the scheduled in-person simulation in previous years of the degree .
Key exclusion criteria (1 listed)
- -the student does not sign the informed consent to participate in the study.
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 |
|---|---|---|
| Experience with virtual reality glassesAlso: Formative interventionIf the group belongs to GE (teaching with in-person simulation in the classroom and teaching with VR headsets), they will also receive the two training sessions described for GC: 30 minutes of individual training through VR (headsets and controllers to perform actions while receiving immediate feedback through VR) before the in-person simulation. | Other | RV INTERVENTION |
Primary outcome
Compare the satisfaction
Time frame: Five months
To compare the satisfaction acquired by students when performing basic cardiopulmonary resuscitation and patient examination between both teaching groups (experimental group - EG: VR plus in-person simulation, control group - CG: in-person simulation). We will mesure this with Satisfaction and Self-Confidence in Learning Scale (SCLS-Sp) (Farrés-Tarafa et al., 2021) .
Compare the self-confidence
Time frame: Five months
To compare the self-confidence acquired by students when performing basic cardiopulmonary resuscitation and patient examination between both teaching groups (experimental group - EG: VR plus in-person simulation, control group - CG: in-person simulation). We will mesure this with Satisfaction and Self-Confidence in Learning Scale (SCLS-Sp) (Farrés-Tarafa et al., 2021) .
5 secondary outcomes
To compare the acquisition of knowledge in each teaching group.
Time frame: Five months
To compare the acquisition of skills in each teaching group.
Time frame: Five months
To evaluate students' tolerance to VR headset technology.
Time frame: Five months
To assess the usability of VR headsets by students.
Time frame: Five months
To analyze the costs of traditional teaching with in-person simulation compared to teaching with VR.
Time frame: Five months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Yes. The study is multicenter, so it is already planned to be shared with other researchers.
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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.
Marta Raurell-Torredà, phD contact
Questions about this trial
What is this clinical trial studying?
A study testing Experience with virtual reality glasses in people with Informed Consent, run by Universitat Jaume I.
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: opening soon, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Almodóvar-Fernández, PhD (+0034636760923, isabelalmodovarfernandez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the satisfaction (time frame: Five months). The study lists 2 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 21 Feb 2025.