Psychological Well BeingREVINCT07742137
REVI Pilot Feasibility Trial in Long-Term Care
A study testing Active IVR and Passive IVR in people with Psychological Well Being and Healthy Volunteers, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This pilot study evaluates the feasibility, safety, and acceptability of an immersive virtual reality (VR) intervention designed to promote psychological well-being in older adults living in a long-term care facility. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well Being, Healthy Volunteers, Aging
- What is being tested?
- Active IVR and Passive IVR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2026to 30 Apr 2026
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents of long-term care facilities.
- Age 65 years or older.
- Full functional independence (Barthel Index = 100).
- Adequate balance and gait to safely participate in VR sessions (Berg Balance Scale > 45).
- Absence of significant cognitive impairment (MMSE ≥ 25 or CAMCOG-R ≥ 80).
- Absence of clinically significant depressive symptoms (GDS-SF ≤ 5).
Show all 10Show fewer
- No prior experience with immersive virtual reality.
- Able to provide informed consent or have a legal representative who can do so.
- Able to remain seated for approximately 20 minutes per session.
- Willing to participate in eight VR sessions over four weeks.
Who cannot join
- Cognitive impairment that prevents understanding instructions or interacting with VR content.
- Depressive symptoms above the screening threshold established in the inclusion criteria.
- Balance or gait limitations judged by clinical staff to pose a safety risk during VR use.
- Medical or neurological conditions that contraindicate VR exposure (e.g., uncontrolled epilepsy, severe motion sickness).
- Acute medical instability or conditions requiring urgent clinical intervention.
- Any condition judged by clinical staff to pose a safety risk during VR immersion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
This pilot study evaluates the feasibility, safety, and acceptability of an immersive virtual reality (VR) intervention designed to promote psychological well-being in older adults living in a long-term care facility. The study examines whether an eight-session VR program can be delivered safely and comfortably, whether participants tolerate and engage with the sessions, and whether the intervention shows preliminary signals of benefit in emotional well-being and subjective experience of presence. The results will inform the design and implementation of a larger, ongoing study using the same protocol.
Read the detailed description
This pilot feasibility study evaluates the implementation of "REVI," a personalized immersive virtual reality (IVR) protocol designed for cognitively intact older adults living in long-term care. The intervention consists of eight individually guided IVR sessions delivered twice weekly over four weeks, using Meta Quest 2 head-mounted displays and browser-based WebXR environments developed to ensure accessibility and comfort. The protocol is explicitly grounded in Ryff's multidimensional model of psychological well-being and the Dignity-by-Design framework, emphasizing personalization, meaningful choice, and user agency as core design principles. Each session targets specific facets of eudaimonic well-being through structured activities such as avatar creation, motor-skills training, immersive visits to personally meaningful places, cooperative tasks, and a life-narrative exercise.
The study uses a three-arm design to compare an Active IVR condition (full REVI protocol), a Passive IVR condition (non-interactive exposure to immersive environments), and a usual-care Control group. All IVR sessions are supervised one-on-one by a trained guide who monitors safety, provides technical support, and facilitates grounding and orientation when needed. The primary focus of this pilot is to assess feasibility (recruitment, retention, procedural consistency) and safety (adverse events, tolerability), as well as acceptability through observer-rated engagement and qualitative in-session feedback. Secondary measures include presence and structured emotional responses collected after immersion sessions. Exploratory outcomes include both state-level indicators aligned with the targeted psychological well-being dimensions and trait-level scores assessed at baseline and one week post-intervention.
The study is designed as an early-stage evaluation of a theory-driven IVR protocol in a real-world residential care setting. Its purpose is to determine whether REVI can be delivered safely, comfortably, and consistently, and whether participants engage meaningfully with the personalized activities. Findings from this feasibility phase will inform refinements to the protocol and guide the development of a future definitive trial.
- Conditions
- Psychological Well Being, Healthy Volunteers, Aging, Long-Term Care
- Being tested
- Active IVR, Passive IVR
- Keywords
- Virtual Reality Exposure, Older Adults, Long-Term Care, Residential Facilities, Psychological Well-Being, Immersive Virtual Reality, Avatar-Based Interaction, Eudaimonic Well-Being, Ryff's Model, Dignity-by-Design, Institutionalized Older Adults, Feasibility Study, Acceptability Study, Pilot Trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active IVRBehavioural
Participants complete eight individually guided immersive virtual reality sessions delivered twice weekly over four weeks. Sessions include structured interaction with immersive virtual environments, guided experiential tasks, and presence-enhancing activities aligned with the psychological well-being model.
Passive IVRBehavioural
Participants complete eight immersive virtual reality sessions delivered twice weekly over four weeks. Sessions consist of passive exposure to immersive virtual environments without guided experiential tasks or structured interaction. Participants view the VR scenarios while remaining seated and without engaging in presence-enhancing activities.
| Study group | Role | What they receive |
|---|---|---|
| Active IVR | Experimental | Participants complete the full REVI protocol, consisting of eight individually guided immersive virtual reality sessions delivered twice weekly over four weeks. Sessions include structured interaction with immersive virtual environments, guided experiential tasks, and presence-enhancing activities aligned with the psychological well-being model. Receives: Behavioral: Active IVR |
| Passive IVR | Experimental | Participants complete eight immersive virtual reality sessions delivered twice weekly over four weeks. Sessions consist of passive exposure to immersive virtual environments without guided experiential tasks or structured interaction. Participants view the VR scenarios through Meta Quest 2 headsets while remaining seated and without engaging in presence-enhancing activities. Receives: Behavioral: Passive IVR |
| Control | No intervention | Participants do not receive any immersive virtual reality sessions. They complete the baseline and post-intervention assessments and join the study schedule at the same time points as the IVR groups to complete the inter-session evaluations appropriate for their condition. Participants receive usual care within the long-term care facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate is defined as the proportion of eligible participants who enroll in the study during the recruitment period.
Measured: At the end of the recruitment period (March 13, 2026).
Retention Rate
Retention rate is defined as the proportion of enrolled participants who complete all scheduled assessments and sessions during the 4-week intervention period.
Measured: From enrollment through completion of the 4-week intervention period.
Adverse Events
Adverse events are monitored throughout the intervention period and recorded after each session, including discomfort, cybersickness, or any unexpected negative reactions.
Measured: From the first session through the final session of the 4-week intervention period.
Acceptability (NPT-ES)
Acceptability is assessed after each session using the adapted Non-Pharmacological Therapy Experience Scale (NPT-ES), which evaluates perceived usefulness, comfort, satisfaction, and willingness to continue the activity.
Measured: Immediately after each session during the 4-week intervention period.
Secondary outcomes (3)
Psychological Well-Being (Ryff Scales)
Psychological well-being is assessed using the Ryff Scales of Psychological Well-Being, which evaluate autonomy, environmental mastery, personal growth, positive relations, purpose in life, and self-acceptance. The full scale is administered at baseline and after the four-week intervention period, and selected subscales are administered at intermediate time points during the intervention to capture short-term changes in specific dimensions of well-being.
Measured: From baseline assessment before starting the intervention through intermediate session assessments during the 4-week program and the post-intervention assessment at 4 weeks.
Sense of Presence (Presence Questionnaire)
Sense of presence is assessed after each immersive session using an adapted version of the Presence Questionnaire (Witmer \& Singer, 1998), which evaluates the participant's subjective feeling of being physically and psychologically located within the virtual environment.
Measured: Immediately after each immersion session during the 4-week intervention period.
Emotional Reactions (Session Questionnaire)
Emotional reactions are assessed after each session using a brief structured questionnaire that evaluates affective responses to the immersive experience, including comfort, enjoyment, and emotional engagement.
Measured: Immediately after each immersion session during the 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start16 Mar 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Well BeingStudies 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
- This study uses a three-arm parallel design in which participants are allocated to one of three conditions (Active IVR, Passive IVR, or Control). All groups follow a matched assessment timeline, although only the IVR groups complete session-based measures (e.g., NPT-ES, presence, qualitative feedback). The Control group completes baseline and post-intervention assessments on the same schedule but does not undergo IVR sessions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Antonio Nieto Escámez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742137
- Sponsor's protocol ID
- REVI-PILOT-2026
- Other IDs
- P_FORT_CENTROS_2023/04
- Acronym
- REVI
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The sample size is small and the data collected include sensitive information from older adults residing in long-term care facilities, making full de-identification insufficient to ensure participant privacy. No repository or mechanism for IPD sharing is planned.
Publications
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
- ClinicalTrials.gov ID
- NCT07742137
- Acronym / sponsor ID
- REVI / REVI-PILOT-2026
- Conditions
- Psychological Well Being, Healthy Volunteers, Aging, Long-Term Care
- Keywords
- Virtual Reality Exposure, Older Adults, Long-Term Care, Residential Facilities, Psychological Well-Being, Immersive Virtual Reality, Avatar-Based Interaction, Eudaimonic Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Aug 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.
This pilot study evaluates the feasibility, safety, and acceptability of an immersive virtual reality (VR) intervention designed to promote psychological well-being in older adults living in a long-term care facility. The study examines whether an eight-session VR program can be delivered safely and comfortably, whether participants tolerate and engage with the sessions, and whether the intervention shows preliminary signals of benefit in emotional well-being and subjective experience of presence. The results will inform the design and implementation of a larger, ongoing study using the same protocol.
Detailed description
This pilot feasibility study evaluates the implementation of "REVI," a personalized immersive virtual reality (IVR) protocol designed for cognitively intact older adults living in long-term care. The intervention consists of eight individually guided IVR sessions delivered twice weekly over four weeks, using Meta Quest 2 head-mounted displays and browser-based WebXR environments developed to ensure accessibility and comfort. The protocol is explicitly grounded in Ryff's multidimensional model of psychological well-being and the Dignity-by-Design framework, emphasizing personalization, meaningful choice, and user agency as core design principles. Each session targets specific facets of eudaimonic well-being through structured activities such as avatar creation, motor-skills training, immersive visits to personally meaningful places, cooperative tasks, and a life-narrative exercise.
The study uses a three-arm design to compare an Active IVR condition (full REVI protocol), a Passive IVR condition (non-interactive exposure to immersive environments), and a usual-care Control group. All IVR sessions are supervised one-on-one by a trained guide who monitors safety, provides technical support, and facilitates grounding and orientation when needed. The primary focus of this pilot is to assess feasibility (recruitment, retention, procedural consistency) and safety (adverse events, tolerability), as well as acceptability through observer-rated engagement and qualitative in-session feedback. Secondary measures include presence and structured emotional responses collected after immersion sessions. Exploratory outcomes include both state-level indicators aligned with the targeted psychological well-being dimensions and trait-level scores assessed at baseline and one week post-intervention.
The study is designed as an early-stage evaluation of a theory-driven IVR protocol in a real-world residential care setting. Its purpose is to determine whether REVI can be delivered safely, comfortably, and consistently, and whether participants engage meaningfully with the personalized activities. Findings from this feasibility phase will inform refinements to the protocol and guide the development of a future definitive trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study uses a three-arm parallel design in which participants are allocated to one of three conditions (Active IVR, Passive IVR, or Control). All groups follow a matched assessment timeline, although only the IVR groups complete session-based measures (e.g., NPT-ES, presence, qualitative feedback). The Control group completes baseline and post-intervention assessments on the same schedule but does not undergo IVR sessions.
| Arm | Type | Receives |
|---|---|---|
| Active IVR | Experimental | Behavioral: Active IVRParticipants complete the full REVI protocol, consisting of eight individually guided immersive virtual reality sessions delivered twice weekly over four weeks. Sessions include structured interaction with immersive virtual environments, guided experiential tasks, and presence-enhancing activities aligned with the psychological well-being model. |
| Passive IVR | Experimental | Behavioral: Passive IVRParticipants complete eight immersive virtual reality sessions delivered twice weekly over four weeks. Sessions consist of passive exposure to immersive virtual environments without guided experiential tasks or structured interaction. Participants view the VR scenarios through Meta Quest 2 headsets while remaining seated and without engaging in presence-enhancing activities. |
| Control | No intervention | –Participants do not receive any immersive virtual reality sessions. They complete the baseline and post-intervention assessments and join the study schedule at the same time points as the IVR groups to complete the inter-session evaluations appropriate for their condition. Participants receive usual care within the long-term care facility. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Residents of long-term care facilities.
- Age 65 years or older.
- Full functional independence (Barthel Index = 100).
- Adequate balance and gait to safely participate in VR sessions (Berg Balance Scale > 45).
- Absence of significant cognitive impairment (MMSE ≥ 25 or CAMCOG-R ≥ 80).
Key exclusion criteria (6 listed)
- Cognitive impairment that prevents understanding instructions or interacting with VR content.
- Depressive symptoms above the screening threshold established in the inclusion criteria.
- Balance or gait limitations judged by clinical staff to pose a safety risk during VR use.
- Medical or neurological conditions that contraindicate VR exposure (e.g., uncontrolled epilepsy, severe motion sickness).
- Acute medical instability or conditions requiring urgent clinical intervention.
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 |
|---|---|---|
| Active IVRParticipants complete eight individually guided immersive virtual reality sessions delivered twice weekly over four weeks. Sessions include structured interaction with immersive virtual environments, guided experiential tasks, and presence-enhancing activities aligned with the psychological well-being model. | Behavioural | Active IVR |
| Passive IVRParticipants complete eight immersive virtual reality sessions delivered twice weekly over four weeks. Sessions consist of passive exposure to immersive virtual environments without guided experiential tasks or structured interaction. Participants view the VR scenarios while remaining seated and without engaging in presence-enhancing activities. | Behavioural | Passive IVR |
Primary outcome
Recruitment Rate
Time frame: At the end of the recruitment period (March 13, 2026).
Recruitment rate is defined as the proportion of eligible participants who enroll in the study during the recruitment period.
Retention Rate
Time frame: From enrollment through completion of the 4-week intervention period.
Retention rate is defined as the proportion of enrolled participants who complete all scheduled assessments and sessions during the 4-week intervention period.
Adverse Events
Time frame: From the first session through the final session of the 4-week intervention period.
Adverse events are monitored throughout the intervention period and recorded after each session, including discomfort, cybersickness, or any unexpected negative reactions.
Acceptability (NPT-ES)
Time frame: Immediately after each session during the 4-week intervention period.
Acceptability is assessed after each session using the adapted Non-Pharmacological Therapy Experience Scale (NPT-ES), which evaluates perceived usefulness, comfort, satisfaction, and willingness to continue the activity.
3 secondary outcomes
Psychological Well-Being (Ryff Scales)
Time frame: From baseline assessment before starting the intervention through intermediate session assessments during the 4-week program and the post-intervention assessment at 4 weeks.
Sense of Presence (Presence Questionnaire)
Time frame: Immediately after each immersion session during the 4-week intervention period.
Emotional Reactions (Session Questionnaire)
Time frame: Immediately after each immersion session during the 4-week intervention period.
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 3 Aug 2026.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The sample size is small and the data collected include sensitive information from older adults residing in long-term care facilities, making full de-identification insufficient to ensure participant privacy. No repository or mechanism for IPD sharing is planned.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active IVR and Passive IVR in people with Psychological Well Being and Healthy Volunteers, run by Universidad de Almeria 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 10 inclusion and 6 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 3 Aug 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?
Recruitment Rate (time frame: At the end of the recruitment period (March 13, 2026).). 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?
On the ClinicalTrials.gov record for NCT07742137, 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 3 Aug 2026.