- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07809581
The Personalized Creation of Immersive Virtual Environments to Promote Emotional Well-being
A Proof-of-Concept Study: The Personalized Creation of Immersive Virtual Environments to Promote Emotional Well-being in Older Adults
Background: Virtual Reality (VR) technology has seen a growing adoption in clinical and healthcare settings. VR applications are both effective and acceptable, with a great potential for populations with mobility restrictions, such as older adults receiving home-based care or in long-term care facilities. However, creating head-mounted display virtual reality (HMD-VR) environments still faces considerable challenges.
Aim: The aim is to create three HMD-VR environments and to carry out a proof of concept to verify their impact on older adults.
Methods: This research uses mixed methodology to design three immersive environments with human-centred design and verify its impact with a study sample consisting of 31 people; 18 women and 13 men, of whom 16 were over 89 years old, 11 were between 79 and 89 years old, and 4 people were between 66 and 77 years old. Each participant viewed the three virtual reality environments and answered the Positive and Negative Affect Schedule (PANAS) scale, the Slater-Usoh-Steed (SUS) Presence Questionnaire, and the Simulator Sickness Questionnaire (SSQ).
Study Overview
Status
Conditions
Detailed Description
Phase I was based on observational, cross-sectional, and mixed-method (quantitative and qualitative) approaches. Phase II was based on a multicentre pre-post quasi-experimental pilot study (proof-of-concept feasibility study) with a cross-sectional design and used a mixed methodology approach combining quantitative and qualitative data.
Phase I was conducted with users of the Home-Based Care (HBC) of the Manlleu City Council, located in the province of Barcelona (Spain). Initial contact and recruitment took place in September 2023, during which potential participants were informed about the aims and procedures of the study. Data collection among eligible HBC users was conducted in November 2023. The inclusion and exclusion criteria were applied jointly with the HBC technical staff to ensure the suitability and safety of the participants.
Phase II was implemented in five residential centres for older adults: La Bona Mar, Vida per l'Avi, Sant Marc, Llar per l'Avi, and Vida als Anys, located in the municipalities of Vilassar de Mar and Mataró (Spain). The centres were first contacted in December 2023, followed by a coordination meeting with the multidisciplinary teams (including social workers, social educators, psychologists, and physiotherapists). Participant selection and recruitment were performed in January 2024, in collaboration with the professional staff of each centre. All eligible residents were considered, considering the clinical criteria. Data collection with residents took place in January and February 2024. In March 2024, additional data were collected from the multidisciplinary teams to obtain their perceptions of the intervention's impact.
Phase I followed a standardized protocol designed to ensure the safe and comfortable use of the HMD-VR device by participants with personal vulnerability factors. The protocol was developed in accordance with recommendations for HMD-VR use in vulnerable populations and considering social and mental health aspects described in recent research.
The protocol was briefly described as follows: an HMD-VR acclimatization period was included, and assistance was provided for properly fitting the HMD-VR headset. A technician provided continuous supervision throughout the session. To ensure immersion and prevent distraction, participants always remained seated within a closed room to block out external sounds during the HMD-VR exposure.
A questionnaire was developed to collect information on participants' preferences, experiences, and relevant elements for the creation of the VR environments. Its structure and content were based on previous work evaluating VR experiences in vulnerable groups.
Participant selection was performed by the management team of the Home Care Service, in collaboration with each participant's reference professional, ensuring full adherence to the inclusion and exclusion criteria.
Data collection took place in participants' homes. Each participant was exposed to four HMD-VR environments presented in random order (alternating order), followed by completion of the questionnaire. The complete session lasted approximately 60 minutes. The technician continuously monitored participants throughout the session for adverse effects (e.g., dizziness, eye strain).
In Phase II, the standardized protocol was also followed. An HMD-VR acclimatization period was included with assistance from the technician to fit the headset correctly. VR Adverse effects (e.g., dizziness, eye strain) were continuously monitored throughout the session. Participants remained seated in a closed room that blocked external noise during the entire VR exposure to guarantee immersion and avoid distractions.
First, a meeting was held with the management and multidisciplinary teams (e.g., social workers, psychologists, physiotherapists) to determine the sample and schedule. Individual data collection sessions were conducted in a designated room at each of the five centers, using the Oculus Quest 2 HMD-VR system.
Each participant completed a questionnaire (10-15 minutes) and was then randomly assigned to one of the three HMD-VR environments. All participants experienced the three HMD-VR environments in alternating order. The total participation time was approximately 60 minutes per individual.
Finally, center staff completed a 10-minute electronic questionnaire (Microsoft Forms) to assess the study's impact on residents, providing sociodemographic, role-related, and impact feedback after providing informed consent.
Study Type
Enrollment (Actual)
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Gender (preference for equality between men and women).
- Users of the Home Care Service (SAD) and elderly people from the five residential centres.
- Age (first phase over 18 years old and second phase over 65 years old).
- Participation in this study was completely voluntary, and all participants signed an informed consent form before taking part in the research.
Exclusion Criteria:
- People who suffer from any anomaly in binocular or auditory vision.
- People with physical or mental disabilities, or pre-existing psychiatric disorders, with serious medical conditions.
- People who suffer from any cardiovascular disease are susceptible to being affected by HMD-VR technology.
- People who suffer from symptoms related to epilepsy.
- People who have any electronic device, such as a cardiac pacemaker or other implanted medical device susceptible to being altered by HMD-VR technology.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Home Care Service.
Users of the Home Care Service (SAD) of the Manlleu City Council.
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Residents.
users of five older adult residences.
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Staff.
Multidisciplinary team working in the five residential centres.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Phase I quantitative data: Assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive),
Time Frame: Day 1. Baseline.
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Participants completed three Likert-scale items assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive), together with one categorical item indicating overall preference. Quantitative Phase I, composed of three questions with a Likert response scale that measure the assessment of the four different experiences (realistic, digital, dreamlike, and interactive) with the VR glasses, and a nominal categorical question with three levels. |
Day 1. Baseline.
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Phase I qualitative data. Participants answered 13 semi-structured interview questions about the contexts (e.g., environments, sounds) they linked to emotional well-being.
Time Frame: Day 1. Baseline.
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Collect information on which aspects (environments, sounds, images, etc.) and experiences are most relevant in VR environments regarding the emotional well-being of the participants to desing three VR enviroments. Phase I qualitative data consisted of semi-structured interviews of thirteen questions. |
Day 1. Baseline.
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Phase II 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.
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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. Verify that the three HMD-VR environments created significantly favourable positive emotions in the participants related to emotional well-being and improved mood. Verify that the three HMD-VR environments created significantly decrease negative emotions in the participants related to emotional well-being and improved mood. |
Day 2. Baseline and Post-intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Phase II quantitative data: The Slater-Usoh-Steed (SUS) Presence Questionnaire to measure perceived presence and immersion
Time Frame: Day 2. Post-intervention.
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Verify the degree of immersion generated in the three HMD-VR environments created in the participants.
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Day 2. Post-intervention.
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Phase II quantitative data: The Simulator Sickness Questionnaire (SSQ) to evaluate physical symptoms associated with HMD-VR exposure.
Time Frame: Day 2. Post-intervention.
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Verify the VR Sickness symptoms after exposure to the three HMD-VR environments created.
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Day 2. Post-intervention.
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Phase II qualitative data: Key informants perception (staff).
Time Frame: Day 3. Post-intervention.
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Evaluate the impact of the study on the residents through the perception of the staff at the centres.
In Phase II, key informants answered 14 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
Investigators
- Principal Investigator: Salvador Simó, PhD, University of Vic-Central University of Catalonia (UVIC-UCC)
Publications and helpful links
General Publications
- Anderson, A. P., Mayer, M. D., Fellows, A. M., Cowan, D. R., Hegel, M. T., and Buckey, J. C. (2017). Relaxation with immersive natural scenes presented using virtual reality. Aerospace medicine and human performance, 88(6), 520-526. https://doi.org/10.3357/AMHP.4747.2017 Appel, L., Appel, E., Bogler, O., Wiseman, M., Cohen, L., Ein, N., Abrams, H. B., and Campos, J. L. (2020). Older adults with cognitive and/or physical impairments can benefit from immersive virtual reality experiences: a feasibility study. Frontiers in Medicine, 6, 329-329. https://doi.org/10.3389/fmed.2019.00329 Bimberg, Pauline and Weissker, Tim and Kulik, Alexander. (2020). On the usage of the simulator sickness questionnaire for virtual reality research. 464-467. 10.1109/VRW50115.2020.00098. Birckhead, B., Khalil, C., Liu, X., Conovitz, S., Rizzo, A., Danovitch, I., Bullock, K., & Spiegel, B. (2019). Recommendations for methodology of virtual reality clinical trials in health care by an international working group: Iterative Study. JMIR mental health, 6(1), e11973. https://doi.org/10.2196/11973 Brungardt, A., Wibben, A., Shanbhag, P., Boeldt, D., Youngwerth, J., Tompkins, A., Rolbiecki, A. J., Coats, H., LaGasse, A. B., Kutner, J. S., & Lum, H. D. (2024). Patient outcomes of a virtual reality-based music therapy pilot in palliative care. Palliative medicine reports, 5(1), 278-285. https://doi.org/10.1089/pmr.2024.0022 Bryant, Brunner, M., and Hemsley, B. (2020). A review of virtual reality technologies in the field of communication disability: implications for practice and research. Disability and Rehabilitation: Assistive Technology, 15(4), 365-372. https://doi.org/10.1080/17483107.2018.1549276 Clemente, D., Romano, L., Zamboni, E., Carrus, G., & Panno, A. (2024). Forest therapy using virtual reality in the older population: a systematic review. Frontiers in Psychology, 14, 1323758-1323758. https://doi.org/10.3389/fpsyg.2023.1323758 Cullen, A.J., Dowling, N.L., Segrave, R. et al. Considerati
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
Keywords
Other Study ID Numbers
- UVic-UCC. Project num.277/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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