Virtual Reality Therapy for Improving Caregiver and Patient Quality of Life in Home-Based Palliative Care in Saudi Arabia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bisha

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Immersive Nature VR

    Device

    The 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

100 Participants
are divided into 2 treatment groups
Group A: Immersive Nature VRExperimental treatment 1 intervention
Group B: Control Group - Treatment as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Week 0) and Week 5 (post-intervention)
2

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.

Time frame
Baseline (Week 0) and Week 5 (Post-intervention)

Secondary outcomes

1

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.

Time frame
Baseline (Week 0) and Week 5 (post-intervention)
2

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

Time frame
Week 5 (post-intervention)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: