Virtual RealityVIRTIC-HajjNCT07567391
Virtual Reality Therapy for Improving Caregiver and Patient Quality of Life in Home-Based Palliative Care in Saudi Arabia
A study testing Immersive Nature VR in people with Virtual Reality and Quality of Life, run by University of Bisha.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Quality of Life, Palliative Care
- What is being tested?
- Immersive Nature VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Virtual Reality, Quality of Life, Palliative Care, Caregivers
- Being tested
- Immersive Nature VR
- Keywords
- Virtual Reality, Palliative Care, Quality of Life, Caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Nature VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Immersive Nature VR |
| Control Group - Treatment as usual | No intervention | The control group will not receive any VR intervention and will receive a treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0) and Week 5 (Post-intervention)
Secondary outcomes (2)
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.
Measured: Baseline (Week 0) and Week 5 (post-intervention)
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
Measured: Week 5 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start20 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bisha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Alanazi, University of Bisha
- Investigators
- Mohammed O Alanazi, PhD, Principal investigator, University of Bisha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567391
- Sponsor's protocol ID
- Ubisha-02
- Acronym
- VIRTIC-Hajj
- Status last verified
- May 2026
- First submitted
- 1 Aug 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37504309Mo 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.
PubMed 35635018Moloney 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.
PubMed 37928326Mercante 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.
PubMed 38186210Perna 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.
PubMed 33583203Kalantari 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.
PubMed 35592668Gaina 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.
PubMed 39765944Austin 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.
PubMed 35064330
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Nature Therapy for Palliative Patients and Caregivers in Saudi Arabia: A Randomized Controlled Trial to Support Quality of Life and Cultural Adaptation
- ClinicalTrials.gov ID
- NCT07567391
- Acronym / sponsor ID
- VIRTIC-Hajj / Ubisha-02
- Conditions
- Virtual Reality, Quality of Life, Palliative Care, Caregivers
- Keywords
- Virtual Reality, Palliative Care, Quality of Life, Caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BishaUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Immersive Nature VR | Experimental | Device: Immersive Nature VRParticipants 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. |
| Control Group - Treatment as usual | No intervention | –The control group will not receive any VR intervention and will receive a treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Nature VRThe 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. | Device | Immersive Nature VR |
Primary outcome
Change in Quality of Life (PROMIS-29)
Time frame: Baseline (Week 0) and Week 5 (post-intervention)
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)
Time frame: Baseline (Week 0) and Week 5 (Post-intervention)
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.
2 secondary outcomes
Caregiver Stress and Emotional State
Time frame: Baseline (Week 0) and Week 5 (post-intervention)
Participant Engagement and Satisfaction (Qualitative)
Time frame: Week 5 (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 37504309Alanazi 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.
- Background: PubMed 35635018Mo 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.
- Background: PubMed 37928326Moloney 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.
- Background: PubMed 38186210Mercante 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.
- Background: PubMed 33583203Perna 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.
- Background: PubMed 35592668Kalantari 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.
- Background: PubMed 39765944Gaina 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.
- Background: PubMed 35064330Austin 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed O Alanazi, PhD principal investigator
University of Bisha
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Nature VR in people with Virtual Reality and Quality of Life, run by University of Bisha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed O Alanazi, PhD (+966533993350, malanazi@ub.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (PROMIS-29) (time frame: Baseline (Week 0) and Week 5 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567391, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.