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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.
This randomized controlled trial investigates the impact of immersive Virtual Reality (VR) nature therapy on quality of life and emotional well-being among palliative care patients and their caregivers in Saudi Arabia. The intervention includes culturally adapted, high-fidelity VR nature environments designed to promote psychological comfort, reduce stress, and provide sensory engagement aligned with local preferences. Participants-dyads of patients and their primary caregivers-will be randomly assigned to either the VR intervention group or a waitlist control group. The study explores outcomes such as changes in quality of life, anxiety, and emotional support using validated patient-reported outcome measures. This trial is among the first in the region to evaluate digital interventions for supportive care in palliative settings and aims to inform scalable, culturally relevant approaches to holistic symptom management in advanced illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immersive Nature VR | Experimental | Participants will receive five 30-minute sessions of immersive VR exposure to culturally relevant nature scenes (e.g., Saudi desert oases, wadis, holy sites, and universal environments like forests and oceans) over five weeks using high-resolution VR headsets. |
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| Control Group - Treatment as usual | No Intervention | The control group will not receive any VR intervention and will receive a treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) and Week 5 (post-intervention) |
| 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. | Baseline (Week 0) and Week 5 (Post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) and Week 5 (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed O Alanazi, PhD | Contact | +966533993350 | malanazi@ub.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed O Alanazi, PhD | University of Bisha | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37504309 | Background | Alanazi MO, Patano A, Bente G, Mason A, Goldstein D, Parsnejad S, Wyatt G, Lehto R. Nature-Based Virtual Reality Feasibility and Acceptability Pilot for Caregiver Respite. Curr Oncol. 2023 Jun 22;30(7):5995-6005. doi: 10.3390/curroncol30070448. | |
| 35635018 | Background | Mo J, Vickerstaff V, Minton O, Tavabie S, Taubert M, Stone P, White N. How effective is virtual reality technology in palliative care? A systematic review and meta-analysis. Palliat Med. 2022 Jul;36(7):1047-1058. doi: 10.1177/02692163221099584. Epub 2022 May 30. |
| Label | URL |
|---|---|
| g R, Woo OKL, Eckhoff D, et al. Participatory Design of a Virtual Reality Life Review Therapy System for Palliative Care. Front Virtual Real. 2024;5:1304615. | View source |
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Due to the sensitive and emotionally delicate nature of the data collected from palliative care patients and their caregivers-including psychological well-being, emotional distress, and physiological responses-maintaining strict confidentiality and privacy is essential. Additionally, IRB policies and ethical approvals may restrict the external sharing of individual-level data to protect the dignity and rights of this vulnerable population. Therefore, IPD will not be shared outside the research team to ensure adherence to ethical and institutional data protection standards.
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This study will conduct an RCT to evaluate the effectiveness of culturally adapted immersive nature VR interventions for palliative patients and their caregivers in Saudi Arabia. Approximately 100 participants will be randomized into an intervention group, which will receive immersive VR nature therapy sessions, or a control group, which will receive a treatment as usual. The VR intervention will feature six natural environments, tailored to cultural preferences, including Saudi-specific landscapes (e.g., desert oases, wadis, holy sites) alongside universal nature settings (beach, forest, mountains) using high quality VR headsets, equipped with user-friendly controllers. Psycho-physiological biomarkers, such as heart rate, heart rate variability (HRV), and breathing patterns, will be measured using brain sensing headband (e.g., MUSE 2 headband).
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| 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 |
| Week 5 (post-intervention) |
| 37928326 | Background | Moloney M, Doody O, O'Reilly M, Lucey M, Callinan J, Exton C, Colreavy S, O'Mahony F, Meskell P, Coffey A. Virtual reality use and patient outcomes in palliative care: A scoping review. Digit Health. 2023 Nov 1;9:20552076231207574. doi: 10.1177/20552076231207574. eCollection 2023 Jan-Dec. |
| 38186210 | Background | Mercante A, Zanin A, Vecchi L, De Tommasi V, Benini F. Virtual reality intervention as support to paediatric palliative care providers: A pilot study. Acta Paediatr. 2024 Apr;113(4):833-834. doi: 10.1111/apa.17099. Epub 2024 Jan 7. No abstract available. |
| 33583203 | Background | Perna MSc Msw L, Lund S, White N, Minton O. The Potential of Personalized Virtual Reality in Palliative Care: A Feasibility Trial. Am J Hosp Palliat Care. 2021 Dec;38(12):1488-1494. doi: 10.1177/1049909121994299. Epub 2021 Feb 15. |
| 35592668 | Background | Kalantari S, Bill Xu T, Mostafavi A, Lee A, Barankevich R, Boot WR, Czaja SJ. Using a Nature-Based Virtual Reality Environment for Improving Mood States and Cognitive Engagement in Older Adults: A Mixed-Method Feasibility Study. Innov Aging. 2022 Mar 17;6(3):igac015. doi: 10.1093/geroni/igac015. eCollection 2022. |
| 39765944 | Background | Gaina AM, Stefanescu C, Szalontay AS, Gaina MA, Poroch V, Mosoiu DV, Stefanescu BV, Axinte M, Tofan CM, Magurianu LA. A Systematic Review of Virtual Reality's Impact on Anxiety During Palliative Care. Healthcare (Basel). 2024 Dec 12;12(24):2517. doi: 10.3390/healthcare12242517. |
| 35064330 | Background | Austin PD, Siddall PJ, Lovell MR. Feasibility and acceptability of virtual reality for cancer pain in people receiving palliative care: a randomised cross-over study. Support Care Cancer. 2022 May;30(5):3995-4005. doi: 10.1007/s00520-022-06824-x. Epub 2022 Jan 21. |
| Wen Y, Shen X, Shen Y. Improving immersive experiences in virtual natural setting for public health and environmental design: A systematic review and meta-analysis of randomized controlled trials. Plos one. 2024 Apr 17;19(4):e0297986. | View source |