Three VR EnvironmentsNCT07817810
Clinic Validation of Three Virtual Reality Environments.
A study testing Clinical validation of HMD-VR environments. in people with Three VR Environments, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
Background: The healthcare sector has particularly embraced Virtual Reality (VR) applications, demonstrating its efficacy in creating relaxing virtual environments reduce stress and anxiety symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Three VR Environments
- What is being tested?
- Clinical validation of HMD-VR environments.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 16 Apr 2024to 17 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of the Intermediate Unit at either of two hospitals: the Hospital de Sant Jaume de Manlleu or the University Hospital of Santa Creu de Vic.
- Individuals aged 18 years or older were included.
- Participation in the study was voluntary, and all individuals provided written informed consent before enrolment.
- Both men and women were eligible, seeking a balanced gender distribution and patient willingness.
Who cannot join
- Binocular or auditory anomalies.
- Pre-existing psychiatric disorders.
- Serious medical conditions (e.g., cardiovascular disease, epilepsy, or implanted electronic devices like pacemakers) that could be negatively impacted by HMD-VR technology.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Vic-Central University of Catalonia (UVIC-UCC)
Vic, Barcelona, 08500
About this study
Official title: Therapeutic Virtual Blue Spaces: Immersive Virtual Environments to Promote the Emotional Well-being of Intermediate Unit Patients.
Background: The healthcare sector has particularly embraced Virtual Reality (VR) applications, demonstrating its efficacy in creating relaxing virtual environments reduce stress and anxiety symptoms. Recent investigations highlight the therapeutic value of nature-based "Head Mounted Display" (HMD)-VR environments as accessible and low-intensity interventions.
Aim: The aim is the health validation of three HMD-VR environments to promote emotional well-being and improve the mood of patients in intermediate units.
Methods: This research uses mixed methodology to validate three VR immersive environments with human-centred design and verify their impact with a study sample consisting of 80 patients from the Intermediate units; 50 women and 30 men, of whom 40 participants viewed the three environments in 3D 360° VR on HMD, and 40 participants viewed the same three environments in 2D on tablets. All participants answered the Positive and Negative Affect Schedule Questionnaire (PANAS), the Slater-Usoh-Steed (SUS), and the Simulator Sickness Questionnaire (SSQ).
Read the detailed description
This study was conducted in two phases. Phase I aimed to examine short-term affective changes following exposure to the developed VR environments, to assess perceived presence, and to evaluate adverse VR sickness symptoms in hospitalized patients. Phase II aimed to evaluate the intervention's impact on patients and the perspectives of key informants within the health centres.
The study was a multicentre experimental study with a pretest-posttest, cross-sectional design and used a mixed-methods approach combining quantitative and qualitative data.
This study conducted prior research to design and create three virtual reality (VR) person-centred design environments inspired by the contributions of people monitored by the Home Care Service of Manlleu City Council. The prior study aimed to identify the characteristics of HMD-VR environments most closely associated with emotional well-being in adults requiring support for daily activities. Results indicated a clear preference for natural landscapes that are highly realistic and free of digital or artificial elements. Additionally, natural elements such as vegetation, flowers, trees, and clear water were repeatedly highlighted as desirable. Regarding auditory components, natural sounds, particularly birdsong, the breeze, and the sound of sea waves, were strongly valued. Participants also valued creative and interactive audiovisual elements. Although the interactive artistic experience was well received, the final design of the environments prioritized simplicity and ease of use to ensure accessibility for the population with cognitive, sensory, or mobility limitations. Full descriptions of the VR environments are included in Annex 1.
To establish implementation procedures and timelines, coordination meetings were conducted with hospital administrators and healthcare coordinators at the two participating sites (HSJM-CHV and HUSC-FHSC) following the development of the three HMD-VR scenarios. Medical staff selected appropriate participants based on established inclusion and exclusion criteria.
Following a period of HMD-VR acclimatization with technician-facilitated headset fitting, participants underwent the VR session under constant supervision. Continuous monitoring was employed to detect any VR adverse effects (e.g., dizziness, eye strain). Immediate attention from the medical professional present was received if any participant reported discomfort. No participants discontinued or withdrew from the study.
A dedicated, isolated room containing one table and two chairs was set up in each Intermediate Unit to maintain controlled experimental conditions. Due to mobility impairments, five participants completed the study from their hospital rooms. Of these, four were lying in bed, while one was seated in a chair next to the bed.
Each participant first provided informed consent using printed information sheets and dual consent verification in both paper and electronic formats. Those who declined participation were excluded from the study.
Participants visualized three environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D 360° on tablets.
Each participant completed a questionnaire (10-15 minutes) and was then randomly assigned to one of the three environments. All participants (Group A and Group B) experienced the three environments in alternating order. The total participation time was approximately 60 minutes per individual.
Feedback from key informants was obtained to complement participant data. Healthcare workers completed a separate 10-minute electronic survey designed to collect their professional observations regarding the system's potential impact on patient care, alongside basic demographic and position data. Informed consent was secured from all staff members before survey completion.
- Conditions
- Three VR Environments
- Being tested
- Clinical validation of HMD-VR environments.
- Keywords
- Virtual reality, Intermediate unit, Affect, Presence, VR Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical validation of HMD-VR environments.Other
The study validated three HMD-VR environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D on tablets.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos Receives: Other: Clinical validation of HMD-VR environments. |
| Grup B | Placebo comparator | Group B (control group) viewed the same content in 2D on tablets. Receives: Other: Clinical validation of HMD-VR environments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
The Barthel Index is a standardized, ordinal scale used to measure a person's level of independence in performing Activities of Daily Living (ADLs). It is one of the most widely used functional assessment tools in clinical and research settings, particularly in geriatrics, rehabilitation, neurology, and nursing.
Measured: Baseline.
Pfeiffer scale.
The Pfeiffer Scale is a brief, widely used screening instrument designed to detect the presence and severity of cognitive impairment in older adults.
Measured: Baseline.
Quantitative data: the Positive and Negative Affect Schedule (PANAS) was used to assess baseline emotional state of the three VR enviroments.
Emotional changing state was assessed after the three VR enviroments. To assess changes in affect before and after exposure to each VR environment, paired-samples tests were used based on the PANAS scale's distribution.
Measured: Day 2. Baseline and Post-intervention.
Qualitative data: a six-item multiple-choice questionnaire was administered to assess participants' subjective experience of the study.
The questionnaire was developed based on a review of previous studies evaluating virtual reality experiences with vulnerable groups.
Measured: Day 3. Post-intervention.
Secondary outcomes (3)
Quantitative data: Simulator Sickness Questionnaire (SSQ).
Evaluates physical discomfort using sixteen items rated from "none" to "severe".
Measured: Day 2. Baseline and Post-intervention.
Quantitative data: he Slater-Usoh-Steed (SUS) Presence Questionnaire.
to measure perceived presence and immersion of the three VR enviroments.
Measured: Day 2. Post-intervention.
Qualitative data: fourteen-item semi-structured questions to key informants (hospital staff).
key informants answered fourteen-item semi-structured questions about their subjective observation of the study's impact on residents.
Measured: Day 3. Post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start16 Apr 2024
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three VR EnvironmentsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was based on a multicenter experimental study, with a pretest-posttest, cross-sectional, and mixed methods (quantitative and qualitative) design.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, University of Barcelona, Consorci Hospitalari de Vic, Hospital de la Santa Creu de Vic
- Responsible party
- Sponsor
- Investigators
- Maite Garolera, PhD, Principal investigator, Consorci Sanitari de TerrassaSalvador Simó-Algado, PhD, Principal investigator, University of Vic-Central University of Catalonia (UVIC-UCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817810
- Sponsor's protocol ID
- CEIm IRIS-CC 23/018
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Virtual Blue Spaces: Immersive Virtual Environments to Promote the Emotional Well-being of Intermediate Unit Patients.
- ClinicalTrials.gov ID
- NCT07817810
- Acronym / sponsor ID
- CEIm IRIS-CC 23/018
- Conditions
- Three VR Environments
- Keywords
- Virtual reality, Intermediate unit, Affect, Presence, VR Sickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, University of Barcelona, Consorci Hospitalari de Vic, Hospital de la Santa Creu de Vic
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 14 Sep 2026 (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.
Background: The healthcare sector has particularly embraced Virtual Reality (VR) applications, demonstrating its efficacy in creating relaxing virtual environments reduce stress and anxiety symptoms. Recent investigations highlight the therapeutic value of nature-based "Head Mounted Display" (HMD)-VR environments as accessible and low-intensity interventions.
Aim: The aim is the health validation of three HMD-VR environments to promote emotional well-being and improve the mood of patients in intermediate units.
Methods: This research uses mixed methodology to validate three VR immersive environments with human-centred design and verify their impact with a study sample consisting of 80 patients from the Intermediate units; 50 women and 30 men, of whom 40 participants viewed the three environments in 3D 360° VR on HMD, and 40 participants viewed the same three environments in 2D on tablets. All participants answered the Positive and Negative Affect Schedule Questionnaire (PANAS), the Slater-Usoh-Steed (SUS), and the Simulator Sickness Questionnaire (SSQ).
Detailed description
This study was conducted in two phases. Phase I aimed to examine short-term affective changes following exposure to the developed VR environments, to assess perceived presence, and to evaluate adverse VR sickness symptoms in hospitalized patients. Phase II aimed to evaluate the intervention's impact on patients and the perspectives of key informants within the health centres.
The study was a multicentre experimental study with a pretest-posttest, cross-sectional design and used a mixed-methods approach combining quantitative and qualitative data.
This study conducted prior research to design and create three virtual reality (VR) person-centred design environments inspired by the contributions of people monitored by the Home Care Service of Manlleu City Council. The prior study aimed to identify the characteristics of HMD-VR environments most closely associated with emotional well-being in adults requiring support for daily activities. Results indicated a clear preference for natural landscapes that are highly realistic and free of digital or artificial elements. Additionally, natural elements such as vegetation, flowers, trees, and clear water were repeatedly highlighted as desirable. Regarding auditory components, natural sounds, particularly birdsong, the breeze, and the sound of sea waves, were strongly valued. Participants also valued creative and interactive audiovisual elements. Although the interactive artistic experience was well received, the final design of the environments prioritized simplicity and ease of use to ensure accessibility for the population with cognitive, sensory, or mobility limitations. Full descriptions of the VR environments are included in Annex 1.
To establish implementation procedures and timelines, coordination meetings were conducted with hospital administrators and healthcare coordinators at the two participating sites (HSJM-CHV and HUSC-FHSC) following the development of the three HMD-VR scenarios. Medical staff selected appropriate participants based on established inclusion and exclusion criteria.
Following a period of HMD-VR acclimatization with technician-facilitated headset fitting, participants underwent the VR session under constant supervision. Continuous monitoring was employed to detect any VR adverse effects (e.g., dizziness, eye strain). Immediate attention from the medical professional present was received if any participant reported discomfort. No participants discontinued or withdrew from the study.
A dedicated, isolated room containing one table and two chairs was set up in each Intermediate Unit to maintain controlled experimental conditions. Due to mobility impairments, five participants completed the study from their hospital rooms. Of these, four were lying in bed, while one was seated in a chair next to the bed.
Each participant first provided informed consent using printed information sheets and dual consent verification in both paper and electronic formats. Those who declined participation were excluded from the study.
Participants visualized three environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D 360° on tablets.
Each participant completed a questionnaire (10-15 minutes) and was then randomly assigned to one of the three environments. All participants (Group A and Group B) experienced the three environments in alternating order. The total participation time was approximately 60 minutes per individual.
Feedback from key informants was obtained to complement participant data. Healthcare workers completed a separate 10-minute electronic survey designed to collect their professional observations regarding the system's potential impact on patient care, alongside basic demographic and position data. Informed consent was secured from all staff members before survey completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was based on a multicenter experimental study, with a pretest-posttest, cross-sectional, and mixed methods (quantitative and qualitative) design.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Clinical validation of HMD-VR environments.Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos |
| Grup B | Placebo comparator | Other: Clinical validation of HMD-VR environments.Group B (control group) viewed the same content in 2D on tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of the Intermediate Unit at either of two hospitals: the Hospital de Sant Jaume de Manlleu or the University Hospital of Santa Creu de Vic.
- Individuals aged 18 years or older were included.
- Participation in the study was voluntary, and all individuals provided written informed consent before enrolment.
- Both men and women were eligible, seeking a balanced gender distribution and patient willingness.
Key exclusion criteria (3 listed)
- Binocular or auditory anomalies.
- Pre-existing psychiatric disorders.
- Serious medical conditions (e.g., cardiovascular disease, epilepsy, or implanted electronic devices like pacemakers) that could be negatively impacted by HMD-VR technology.
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 |
|---|---|---|
| Clinical validation of HMD-VR environments.The study validated three HMD-VR environments by comparing two participant groups: Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos, and Group B (control group) viewed the same content in 2D on tablets. | Other | Group A, Grup B |
Primary outcome
Barthel Index
Time frame: Baseline.
The Barthel Index is a standardized, ordinal scale used to measure a person's level of independence in performing Activities of Daily Living (ADLs). It is one of the most widely used functional assessment tools in clinical and research settings, particularly in geriatrics, rehabilitation, neurology, and nursing.
Pfeiffer scale.
Time frame: Baseline.
The Pfeiffer Scale is a brief, widely used screening instrument designed to detect the presence and severity of cognitive impairment in older adults.
Quantitative data: the Positive and Negative Affect Schedule (PANAS) was used to assess baseline emotional state of the three VR enviroments.
Time frame: Day 2. Baseline and Post-intervention.
Emotional changing state was assessed after the three VR enviroments. To assess changes in affect before and after exposure to each VR environment, paired-samples tests were used based on the PANAS scale's distribution.
Qualitative data: a six-item multiple-choice questionnaire was administered to assess participants' subjective experience of the study.
Time frame: Day 3. Post-intervention.
The questionnaire was developed based on a review of previous studies evaluating virtual reality experiences with vulnerable groups.
3 secondary outcomes
Quantitative data: Simulator Sickness Questionnaire (SSQ).
Time frame: Day 2. Baseline and Post-intervention.
Quantitative data: he Slater-Usoh-Steed (SUS) Presence Questionnaire.
Time frame: Day 2. Post-intervention.
Qualitative data: fourteen-item semi-structured questions to key informants (hospital staff).
Time frame: Day 3. Post-intervention.
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 14 Sep 2026.
- Related InfoLink provided by the sponsor.
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.
Maite Garolera, PhD principal investigator
Consorci Sanitari de Terrassa
Salvador Simó-Algado, PhD principal investigator
University of Vic-Central University of Catalonia (UVIC-UCC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical validation of HMD-VR environments. in people with Three VR Environments, run by University of Vic - Central University of Catalonia 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 4 inclusion and 3 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 14 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
Barthel Index (time frame: Baseline.). The study lists 4 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 14 Sep 2026.