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Pilot Study Evaluating the Therapeutic Effects of Passive Exposure Virtual Reality on Pain, Anxiety, Fatigue, and Well-being in Patients With Complex Palliative Care Needs.

NCT07214090 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-10-09

No results posted yet for this study

Summary

The EPURAVAS "Pilot Study Using Augmented and Virtual Reality to Ease Suffering in Palliative Care" study is designed to investigate a non-medication treatment for complex symptoms in palliative care.

The purpose is to assess the clinical effectiveness of Virtual Reality (VR) exposure as a way to relieve the distressing symptoms experienced by individuals receiving specialized palliative care.

The study seeks to determine if immersive Passive Exposure Virtual Reality (RVEP) is more effective at providing a significant reduction in pain and anxiety, and a greater overall improvement in well-being and quality of life for patients in complex palliative situations, compared to a control virtual reality approach.

In the study, individuals are randomly assigned to one of two groups for a week:

* Immersive VR: A headset completely surrounds the user in a calming, computer-generated world, aiming to deeply distract the mind from discomfort.
* Control VR: A different headset allows the user to still see the real room while potentially having some virtual elements added. This acts as a comparison to measure the specific benefits of the deep immersion.

Participation involves daily 10-minute VR sessions for seven days. Throughout this time, physiological measurements are safely and continuously recorded using the VR headset and a connected watch. This collects objective information on how the body is reacting-things like brain activity, heart rate, and breathing-to scientifically determine the treatment's impact.

Conditions

  • Palliative Care

Interventions

BEHAVIORAL

Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT)

This intervention uses a transparent augmented virtual reality headset equipped with forward-facing cameras that capture the patient's real-world environment in real time. Transparent virtual and augmented reality overlays computer-generated elements (e.g., visual cues, guidance, or interactive content) onto the live view of the physical environment. This approach maintains a strong anchoring in reality while providing therapeutic visual enhancements, tailored in real-time to the patient's responses. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff.

BEHAVIORAL

Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)

This intervention involves the use of a head-mounted display to immerse the patient in a fully computer-generated virtual environment. The virtual reality passive exposure is designed to distract patients from painful or anxiety-inducing sensations by engaging multiple sensory modalities (visual, auditory, and occasionally tactile). Patients are exposed to relaxing or engaging scenarios, such as natural landscapes or calm immersive scenes, without requiring interaction. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-05-01
Completion
2026-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214090 on ClinicalTrials.gov