REVI Pilot Feasibility Trial in Long-Term Care

NCT07742137 | Completed

• 2 other identifiers: REVI-PILOT-2026P_FORT_CENTROS_2023/04
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Ryff's Model; Dignity-by-Design; Institutionalized Older Adults; Feasibility Study; Acceptability Study; Pilot Trial

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Recruitment rate is defined as the proportion of eligible participants who enroll in the study during the recruitment period.

  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.

  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.

  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.

  Immediately after each session during the 4-week intervention period.

Secondary Outcomes (3)

• Psychological Well-Being (Ryff Scales)

  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)

  Immediately after each immersion session during the 4-week intervention period.

• Emotional Reactions (Session Questionnaire)

  Immediately after each immersion session during the 4-week intervention period.

Study Arms (3)

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.

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.

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.

Interventions

Active IVR BEHAVIORAL

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.

Active IVR

Passive IVR BEHAVIORAL

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.

Passive IVR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Cognitive impairment that prevents understanding instructions or interacting with VR content.
• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Residencia San Juan de Dios

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 15189396 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Only the investigator responsible for assigning participants to the three study groups was masked to participant identity during allocation. No other study personnel, participants, or outcome assessors were masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: March 16, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)