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NCT07742137

Overview

NCT ID: NCT07742137
Lead Sponsor: Universidad de AlmeriaOTHER
Official Title: Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
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

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Mar 16, 2026Actual
Primary Completion Date: Apr 30, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 18Actual
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Residencia San Juan de Dios

Similar Studies

Participant Group/Arms

Active IVRExperimental

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 IVRExperimental

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

ControlNo 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.