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

N/ANot Yet RecruitingNCT07545928

University Hospital, Strasbourg, France20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Palliative Care Refractory Pain

Interventions

ZenctuaryVR+ Interactive Virtual RealityDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * VRISE score ≤ 25 after the VR familiarization procedure * Affiliation with the Social Security system or beneficiary of such social protection. * Signed consent from, able to understand and complete the questionnaires in French. Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

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

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).

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.