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. (EPURAVAS)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Palliative Care

Treatments: Behavioral: Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP); Behavioral: Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT)

Study type: Observational

Funder types: Other

Identifiers

NCT07214090

9787

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥ 18 years old
• Hospitalized in the palliative care unit or followed by the mobile palliative care team of the Strasbourg University Hospitals
• Estimated life expectancy > 1 month (Pronopall score calculated based on medical record data)
• Affiliated with a social security scheme
• Able to understand the objectives and risks of the trial
• Able to understand and complete study questionnaires written in French
• Reachable by phone or email for the entire duration of participation in the study

Exclusion criteria

• Patient with a psychotic mental illness, followed and treated before the study, and not stabilized
• Patient with a severe neurological disease, followed and treated before the study, and not stabilized
• Patient with visual or auditory disorders, or motion sickness, present before the study, that could interfere with the use of virtual reality
• Patient under legal protection or unable to express their consent

Trial design

40 participants in 2 patient groups

RVAT

Description:

The RVAT group serves as the control against which the experimental RVEP method is measured. Individuals in this group use a headset that is designed to be transparent or augmented, allowing them to remain aware of and oriented to their actual environment-the room they are in. While they may see some minimal virtual elements, there is no escape or full immersion into an alternative reality.

Treatment:

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

RVEP

Description:

Individuals in this group use a VR headset that creates a full sensory immersion, meaning the real world is completely blocked out. The experience involves being transported into calming, computer-generated environments, such as tranquil nature scenes. The goal of this full immersion is to achieve a deep, passive distraction that effectively shifts attention away from symptoms like pain and anxiety.

Treatment:

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