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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ZenctuaryVR+ Interactive Virtual Reality

    Device

    The 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

20 Participants
are divided into 1 treatment group
Group A: Interactive Virtual Reality (VR) InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility Success : Adherence

The participant must complete at least 11 out of the 14 planned daily interactive VR sessions.

Time frame
During the 14-day intervention period.
2

Feasibility Success : Duration

The mean duration of all completed sessions (J1 through J14) must be ≥ 7.5 minutes.

Time frame
Calculated at the end of the 14-day period
3

Feasibility Success : Safety

Continuous monitoring for any serious adverse events definitely or probably related to the device throughout the entire study duration.

Time frame
From Day 1 (first VR exposure) to Day 14 (final session).
4

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

Time frame
Assessed daily, immediately following each VR session, over the 14-day period.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Strasbourg, France

Lead sponsor

MOME, University of Arts and Design

Collaborator

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