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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
ZenctuaryVR+ Interactive Virtual Reality
DeviceThe ZenctuaryVR+ intervention is an interactive virtual reality (VR) program delivered via a Head-Mounted Display (HMD) equipped with physiological biosensors (EEG and skin conductance). Participants are immersed in a calming natural environment where they perform simple, low-cognitive-load interactions (grabbing/moving virtual objects) to promote autonomy and provide distraction from refractory symptoms. The intervention is administered once daily for a 10-minute session over 14 consecutive days. Each session is supervised by a trained hospital psychologist or mental-health staff member who monitors the patient's experience in real-time via a tablet. Safety is ensured through a daily bedside "go/no-go" clinical assessment and the use of the VRISE scale to monitor for cybersickness. This supportive care tool is used alongside standard palliative pharmacological treatments.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility Success : Adherence
The participant must complete at least 11 out of the 14 planned daily interactive VR sessions.
Feasibility Success : Duration
The mean duration of all completed sessions (J1 through J14) must be ≥ 7.5 minutes.
Feasibility Success : Safety
Continuous monitoring for any serious adverse events definitely or probably related to the device throughout the entire study duration.
Feasibility Success : Tolerance
VRISE Score assessed daily, immediately following each VR session. The final average score, calculated from the 14 daily post-session assessments, must be ≥ 25
Sponsors and contacts
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University Hospital, Strasbourg, France
Lead sponsor
MOME, University of Arts and Design
Collaborator
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