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Three VR EnviromentsNCT07809581

The Personalized Creation of Immersive Virtual Environments to Promote Emotional Well-being

An observational study of Three VR Enviroments, run by University of Vic - Central University of Catalonia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 minutes and olderHealthy volunteers can take part
Conditions the study is for
Three VR Enviroments
How many people
31 participants
Where
1 siteSpain
Study dates
1 Dec 2023to 15 Apr 2024
How long will I take part?
1 Day
Phase
Observational
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 minutes and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: This study was conducted in two phases. Phase I aimed to identify the characteristics of VR environments most closely associated with emotional well-being in adults requiring support with daily activities. Phase II was a proof-of-concept study with three aims: 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 older adults with support needs.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Vic-Central University of Catalonia (UVIC-UCC)

    Vic, Barcelona, 08500

Other trials in Spain

About this study

Official title: 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).

Read the 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.

Keywords
Virtual Reality, Older adults, VR Sickness, Presence, Affect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07809581
Study groupRoleWhat they receive
Home Care Service.Users of the Home Care Service (SAD) of the Manlleu City Council.
Residents.users of five older adult residences.
Staff.Multidisciplinary team working in the five residential centres.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I quantitative data: Assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive),

    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.

    Measured: Day 1. Baseline.

  2. Phase I qualitative data. Participants answered 13 semi-structured interview questions about the contexts (e.g., environments, sounds) they linked to emotional well-being.

    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.

    Measured: Day 1. Baseline.

  3. Phase II 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.

    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.

    Measured: Day 2. Baseline and Post-intervention.

Secondary outcomes (3)
  1. Phase II quantitative data: The Slater-Usoh-Steed (SUS) Presence Questionnaire to measure perceived presence and immersion

    Verify the degree of immersion generated in the three HMD-VR environments created in the participants.

    Measured: Day 2. Post-intervention.

  2. Phase II quantitative data: The Simulator Sickness Questionnaire (SSQ) to evaluate physical symptoms associated with HMD-VR exposure.

    Verify the VR Sickness symptoms after exposure to the three HMD-VR environments created.

    Measured: Day 2. Post-intervention.

  3. Phase II qualitative data: Key informants perception (staff).

    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:

    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.

  1. First posted9 Sep 2026
  2. Study start1 Dec 2023
  3. Primary completion15 Mar 2024
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
31 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07809581
Sponsor's protocol ID
UVic-UCC. Project num.277/2023
Status last verified
Sep 2026
First submitted
27 Mar 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Three VR Enviroments, 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 5 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 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. 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?

Phase I quantitative data: Assessing their perceptions of the four VR environments (realistic, digital, dreamlike, and interactive), (time frame: Day 1. Baseline.). 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?

On the ClinicalTrials.gov record for NCT07809581, which also lists 1 linked publication.

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 Sep 2026.

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