An interventional study of Active IVR Group and Passive IVR Goup in Healthy Volunteers and Aging, Healthy, sponsored by Francisco Antonio Nieto Escámez. Recruiting at 2 sites in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Francisco Antonio Nieto Escámez · Not applicable, Interventional, and Supportive care
This randomized controlled trial (N = 60) evaluates the acceptability and efficacy of an immersive virtual reality (IVR) intervention designed to enhance psychological well-being in older adults without cognitive impairment living in long-term care facilities. The intervention protocol consists of 12 sessions combining guided reminiscence, relaxation, and virtual cultural experiences. In addition, the study analyzes participants' speech and prosody during the sessions to evaluate emotional responses elicited by the virtual environments.
This study evaluates the implementation of "Well-being RRCE," an immersive virtual reality (IVR) protocol designed for cognitively intact older adults living in long-term care. The intervention consists of 12 guided IVR sessions, using Meta Quest 2 head-mounted displays and browser-based WebXR environments developed to ensure accessibility and comfort. Following an initial pilot study with 12 participants that demonstrated feasibility, safety, and acceptability. This randomized controlled trial involves a total targeted sample of 60 participants (N = 60).
Participants are randomly allocated into three groups:
Active IVR Group: Participants receive the full 12-session "Well-Being RRCE" protocol, administered in small groups (2-4 participants), 3 times per week over 4 weeks (20 minutes per session). The protocol integrates three distinct intervention components: Reminiscence, Relaxation, and Cultural Experiences. Their verbal interactions are recorded via headworn microphones for exploratory qualitative and affective analysis.
Passive IVR Group: Participants undergo 12 sessions over 4 weeks (3 times per week, 20 minutes/session) administered in small groups (2-4 participants) of non-interactive exposure to immersive virtual environments of architectural or cultural interest with basic descriptive information provided by a facilitator, without guided reminiscence, relaxation, or discourse recording.
Control Group: Participants receive usual care and continue their standard facility routines (news workshops, gerontological exercise, cognitive stimulation, recreational activities, and guided walks) without receiving any IVR exposure.
The primary objective of this study is to examine the effect of the intervention on protocol acceptability and participants' subjective well-being. Additionally, it aims to evaluate the level of emotional response experienced by participants by analyzing their speech discourse and prosody during the different IVR sessions.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 60 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →This is the only study on the registry with Francisco Antonio Nieto Escámez as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(6) Willing to participate in 12 VR sessions over four weeks.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete the full Well-Being RRCE protocol, consisting of twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of guided experiential tasks within immersive virtual environments focused on reminiscence, relaxation, and cultural experiences. Participants will answer questions during the guided sessions, and their audio responses will be recorded for subsequent analysis.
Behavioral: Active IVR Group
Participants complete twelve group guided immersive virtual reality (IVR) sessions delivered three times a week over four weeks. Sessions consist of passive exposure to virtual environments, during which the activity guide provides a brief description of the virtual space the participants are viewing, without requiring active tasks or participant responses.
Behavioral: Passive IVR Goup
Participants do not receive any immersive virtual reality sessions. They complete baseline, mid-intervention, and post-intervention assessments on the same timeline as the IVR groups to complete the evaluations appropriate for their condition. Participants continue to receive their usual care within the long-term care facility.
Participants undergo twelve 20-minute sessions of active immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session includes interactive, guided experiential tasks within virtual environments tailored to reminiscence, relaxation, and cultural experiences. During these active sessions, participants respond verbally to structured prompts provided by the facilitator, and their speech audio is recorded for subsequent prosodic and emotional analysis
Participants undergo twelve 20-minute sessions of passive immersive virtual reality (IVR) delivered three times a week over a four-week period using head-mounted displays (HMDs). Each session consists of observational exposure strictly to cultural environments that are distinct from those used in the active condition. During sessions, participants passively view these unique virtual scenarios while a facilitator provides a brief, standardized description of the space.
Positive and Negative Affect (I-PANAS-SF)
Positive and negative affect will be assessed using the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). The questionnaire contains 10 items rated on a 5-point Likert scale and yields separate Positive Affect and Negative Affect subscale scores ranging from 5 to 25. Higher Positive Affect scores indicate greater positive affect, whereas higher Negative Affect scores indicate greater negative affect.
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Affect Balance (EBA)
Affect balance will be assessed using the Affect Balance Scale (Escala de Balance Afectivo, EBA; Godoy-Izquierdo et al., 2008). The instrument contains 18 items rated on a 3-point Likert scale and comprises Positive Affect and Negative Affect subscales (9 items each). An Affect Balance Index is calculated by subtracting the Negative Affect score from the Positive Affect score, yielding a total score ranging from -18 to +18. Higher scores indicate a more positive affective balance, whereas lower scores indicate a predominance of negative affect.
Time frame: Assessed at baseline (T0), at the end of each intervention week (sessions 3, 6, 9, and 12), and 1 week after completion of the intervention (T1).
Life Satisfaction (SWLS)
Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS). The instrument consists of 5 items rated on a 7-point Likert scale with visual support, yielding a total score ranging from 5 to 35. Higher scores indicate greater satisfaction with life.
Time frame: Assessed at baseline (T0) and 1 week after completion of the intervention (T1).
Self-Perceived Well-Being
Self-perceived well-being will be assessed using a single-item numerical rating scale ranging from 1 to 10. Participants in the IVR intervention groups will rate their immediate post-session well-being. Higher scores indicate greater perceived well-being.
Time frame: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
State Anxiety (STAIr-State)
State anxiety will be assessed using the State subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 6 dichotomous items, yielding scores ranging from 0 to 6. Higher scores indicate higher levels of state anxiety.
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Trait Anxiety (STAIr-Trait)
Trait anxiety will be assessed using the Trait subscale of the short version of the State-Trait Anxiety Inventory (STAIr). The subscale consists of 7 dichotomous items, yielding scores ranging from 0 to 7. Higher scores indicate higher levels of trait anxiety.
Time frame: Assessed at baseline (T0), immediately following each intervention session, and 1 week after completion of the intervention (T1).
Acceptability of the Intervention (NPT-ES)
Acceptability of the intervention will be assessed using the adapted Non-Pharmacological Therapy Experience Scale (NPT-ES). This facilitator-rated scale consists of 5 items evaluating participation, pleasure, relationships with others, discomfort, and rejection, each rated on a 4-point scale (0-3). Item scores are summed to generate a total score ranging from 0 to 15, with higher scores indicating a more positive intervention experience and greater acceptability.
Time frame: Assessed immediately following each intervention session (12 sessions).
Participant Feedback on Virtual Environments
Participants in the immersive virtual reality intervention groups will complete an ad hoc 5-item questionnaire after each session. Responses are recorded as Yes/No and assess whether the virtual environments elicited feelings of excitement, calmness, discomfort, restlessness, and perceived realism.
Time frame: Assessed immediately following each intervention session (12 sessions; IVR intervention groups only).
Post-Intervention Participant Feedback
Post-intervention feedback will be collected from participants in the immersive virtual reality (IVR) groups using study-specific questionnaires administered 1 week after completion of the intervention. The questionnaires evaluate participants' perceptions of well-being associated with the IVR experience, including identification of the session types and virtual environments that generated the greatest sense of well-being. Responses include selection of preferred experiences and ratings of perceived well-being on a 1-10 scale.
Time frame: One week after the intervention (T1)
Plan to share: No
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