About this trial
This randomized controlled trial evaluates the efficacy of a culturally adapted virtual reality (VR) nature therapy intervention aimed at improving the quality of life (QOL) and emotional well-being of palliative patients and their family caregivers in Saudi Arabia. The study involves immersive VR sessions depicting natural environments, including Saudi-specific landscapes, delivered to patient-caregiver dyads at home. Outcomes include self-reported QOL measures, psychophysiological parameters, and qualitative feedback.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) receiving palliative care in Saudi Arabia
Primary family caregivers living with and providing daily care to the patient
Ability to provide informed consent
Fluent in Arabic
Disqualifiers
Severe cognitive impairment or psychiatric conditions that prevent use of VR
History of epilepsy or vestibular disorders
Inability to understand or follow instructions for using VR equipment
Trial design
Parallel
Treatments tested in this trial
Immersive Nature VR
DeviceThe VR intervention will consist of a series of sessions using high-resolution VR headsets and user-friendly handheld controllers. The virtual environments will include six immersive nature scenes-three tailored to Saudi cultural preferences (e.g., desert oases, wadis, and Mecca-related sites), and three universally calming settings (e.g., beach, forest, and mountain landscapes). The intervention is designed to offer therapeutic sensory engagement and emotional respite.
Treatment groups
Trial outcomes
Primary outcomes
Change in Quality of Life (PROMIS-29)
The PROMIS-29 assesses health-related quality of life across seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, social participation, and pain interference. Each domain is scored on a standardized T-score scale ranging from 0 to 100. Higher scores indicate better functioning for physical function and social participation domains, and worse symptoms for anxiety, depression, fatigue, pain interference, and sleep disturbance.
Change in Heart Rate Variability (HRV)
Heart rate variability (HRV) will be measured using the MUSE 2 headband. HRV metrics will be recorded prior to the first VR session (baseline) and during intervention sessions. Analysis will compare HRV at baseline and at the end of the intervention. Higher HRV values indicate better autonomic nervous system regulation and greater stress resilience.
Secondary outcomes
Caregiver Stress and Emotional State
Caregiver stress and emotional distress will be assessed using validated self-report scales (e.g., perceived stress and emotional distress measures). Higher scores indicate greater levels of stress and emotional burden.
Participant Engagement and Satisfaction (Qualitative)
Semi-structured interviews will be conducted to explore participant engagement, acceptability, emotional impact, and cultural relevance of the VR intervention. Interviews will be conducted by trained research staff and analyzed using qualitative methods
Locations
Sponsors and contacts
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