Clinic Validation of Three Virtual Reality Environments.
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Vic, Barcelona, Spain, 08500
- University of Vic-Central University of Catalonia (UVIC-UCC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria.
- 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.
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
Group A used a head-mounted display (HMD-VR, Oculus Quest 2) to view 3D 360° VR videos
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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.
|
|
Placebo Comparator: Grup B
Group B (control group) viewed the same content in 2D on tablets.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline.
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Pfeiffer scale.
Time Frame: Baseline.
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The Pfeiffer Scale is a brief, widely used screening instrument designed to detect the presence and severity of cognitive impairment in older adults.
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Baseline.
|
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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.
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Day 2. Baseline and Post-intervention.
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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.
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Day 3. Post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative data: Simulator Sickness Questionnaire (SSQ).
Time Frame: Day 2. Baseline and Post-intervention.
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Evaluates physical discomfort using sixteen items rated from "none" to "severe".
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Day 2. Baseline and Post-intervention.
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Quantitative data: he Slater-Usoh-Steed (SUS) Presence Questionnaire.
Time Frame: Day 2. Post-intervention.
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to measure perceived presence and immersion of the three VR enviroments.
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Day 2. Post-intervention.
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Qualitative data: fourteen-item semi-structured questions to key informants (hospital staff).
Time Frame: Day 3. Post-intervention.
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key informants answered fourteen-item semi-structured questions about their subjective observation of the study's impact on residents.
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Day 3. Post-intervention.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maite Garolera, PhD, Consorci Sanitari de Terrassa
- Principal Investigator: Salvador Simó-Algado, PhD, University of Vic-Central University of Catalonia (UVIC-UCC)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CEIm IRIS-CC 23/018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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