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

3. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Immersive Nature VR
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.
Ingen indgriben: Control Group - Treatment as usual
The control group will not receive any VR intervention and will receive a treatment as usual.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quality of Life (PROMIS-29)
Tidsramme: 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.
Baseline (Week 0) and Week 5 (post-intervention)
Change in Heart Rate Variability (HRV)
Tidsramme: 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.
Baseline (Week 0) and Week 5 (Post-intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Caregiver Stress and Emotional State
Tidsramme: Baseline (Week 0) and Week 5 (post-intervention)
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.
Baseline (Week 0) and Week 5 (post-intervention)
Participant Engagement and Satisfaction (Qualitative)
Tidsramme: Week 5 (post-intervention)
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
Week 5 (post-intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Bisha

Efterforskere

  • Ledende efterforsker: Mohammed O Alanazi, PhD, University of Bisha

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

1. august 2025

Først indsendt, der opfyldte QC-kriterier

3. maj 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Ubisha-02

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

Kliniske forsøg med Immersive Nature VR

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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