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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mohammed O Alanazi, PhD
- 電話番号：+966533993350
- メール：malanazi@ub.edu.sa
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Quality of Life (PROMIS-29)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Caregiver Stress and Emotional State
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Mohammed O Alanazi, PhD、University of Bisha
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月20日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2025年8月1日
QC基準を満たした最初の提出物
2026年5月3日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月5日
QC基準を満たした最後の更新が送信されました
2026年5月3日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Ubisha-02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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