Virtual Reality Therapy for Improving Caregiver and Patient Quality of Life in Home-Based Palliative Care in Saudi Arabia (VIRTIC-Hajj)
3 mei 2026 bijgewerkt door: Mohammed Alanazi, University of Bisha
Virtual Reality Nature Therapy for Palliative Patients and Caregivers in Saudi Arabia: A Randomized Controlled Trial to Support Quality of Life and Cultural Adaptation
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Mohammed O Alanazi, PhD
- Telefoonnummer: +966533993350
- E-mail: malanazi@ub.edu.sa
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Immersive Nature VR
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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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.
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Geen tussenkomst: Control Group - Treatment as usual
The control group will not receive any VR intervention and will receive a treatment as usual.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Quality of Life (PROMIS-29)
Tijdsspanne: Baseline (Week 0) and Week 5 (post-intervention)
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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.
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Baseline (Week 0) and Week 5 (post-intervention)
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Change in Heart Rate Variability (HRV)
Tijdsspanne: Baseline (Week 0) and Week 5 (Post-intervention)
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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.
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Baseline (Week 0) and Week 5 (Post-intervention)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Caregiver Stress and Emotional State
Tijdsspanne: Baseline (Week 0) and Week 5 (post-intervention)
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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.
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Baseline (Week 0) and Week 5 (post-intervention)
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Participant Engagement and Satisfaction (Qualitative)
Tijdsspanne: Week 5 (post-intervention)
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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
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Week 5 (post-intervention)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mohammed O Alanazi, PhD, University of Bisha
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Nuttige links
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
20 oktober 2026
Primaire voltooiing (Geschat)
1 april 2027
Studie voltooiing (Geschat)
1 september 2027
Studieregistratiedata
Eerst ingediend
1 augustus 2025
Eerst ingediend dat voldeed aan de QC-criteria
3 mei 2026
Eerst geplaatst (Werkelijk)
5 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
3 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Ubisha-02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .