Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

Palliative care patients frequently face a "symptom cluster" of pain (up to 96%), fatigue (up to 90%), and anxiety (up to 79%), which severely degrades their quality of life in their final months.The study is built on the concept of passive exposure therapy (VREP), which engages multiple senses to distract the brain from pain signals. By creating an "immersive distraction" or a "flow state," VR can activate the brain's reward networks and reduce activity in areas associated with pain perception. Unlike most existing VR research in palliative care which uses "passive" VR (like watching a 360-degree video), this study uses interactive VR. Patients can perform simple actions-like grabbing or dropping virtual objects-within a calming natural environment, which may better support their sense of autonomy and dignity. Because this is a pilot study, the "Go/No-Go" decision for future larger trials depends on a strict composite of three factors:

* Adherence: The patient must complete at least 11 out of 14 planned daily sessions. * Duration: Each session must average at least 7.5 minutes of usable VR exposure. * Tolerance: The patient must experience no device-related serious adverse events and maintain a high average tolerance score (VRISE score ≥ 25).

Eligibility criteria

Qualifiers

Patient ≥ 18 years old, hospitalized at the USP - HUS

Estimated life expectancy ≥ 1 month (Pronopall score based on clinical data).

Montreal Cognitive Assessment (MoCA) scale score ≥ 26.

Able to understand the objective and risks of the study

Disqualifiers

Patients with psychiatric disease

Patients under court protection

Uncontrolled epilepsy

Visual impairments (lack of binocular vision, blindness) and/or hearing impairments (deafness) preventing the use of virtual reality

Trial design

Treatments tested in this trial

  • ZenctuaryVR+ Interactive Virtual Reality

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Strasbourg, France

Lead sponsor

MOME, University of Arts and Design

Collaborator