Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
研究者
Francisco Antonio Nieto Escámez
Assistant Professor of Psychology, Principal Investigator
Universidad de Almeria