Virtual Reality Therapy for Improving Caregiver and Patient Quality of Life in Home-Based Palliative Care in Saudi Arabia

NCT07567391 | Not Yet Recruiting DMC

• 1 other identifier: Ubisha-02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Virtual Reality; Quality of Life; Palliative Care; Caregivers

Keywords

Virtual Reality; Palliative Care; Quality of Life; Caregivers

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Caregiver Stress and Emotional State

  Baseline (Week 0) and Week 5 (post-intervention)

• Participant Engagement and Satisfaction (Qualitative)

  Week 5 (post-intervention)

Study Arms (2)

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.

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.

Interventions

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.

Immersive Nature VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bisha: lead

Related Publications (8)

• 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.

  PMID: 37504309 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.

  PMID: 35635018 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.

  PMID: 37928326 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.

  PMID: 38186210 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.

  PMID: 33583203 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.

  PMID: 35592668 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.

  PMID: 39765944 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.

  PMID: 35064330 BACKGROUND

Related 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.

Study Officials

• Mohammed O Alanazi, PhD

  University of Bisha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed O Alanazi, PhD

CONTACT

+966533993350; malanazi@ub.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: May 5, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share