Virtual Reality Therapy for Improving Caregiver and Patient Quality of Life in Home-Based Palliative Care in Saudi Arabia (VIRTIC-Hajj)
2026年5月3日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mohammed O Alanazi, PhD
- 电话号码：+966533993350
- 邮箱：malanazi@ub.edu.sa
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Quality of Life (PROMIS-29)
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Caregiver Stress and Emotional State
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mohammed O Alanazi, PhD、University of Bisha
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
有用的网址
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月20日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2025年8月1日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年5月3日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.