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Not yet recruiting Not applicable NCT07545928

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

No applicable phase (e.g. observational)
Conditions: Palliative Care Refractory Pain Anxiety Depression Disorders Fatigue, Mental Psychological Distress

Sponsor: University Hospital, Strasbourg, France

trial.available_in: БГ
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).
Who can participate
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
Interventions
ZenctuaryVR+ Interactive Virtual Reality
DEVICE
Locations 1
France (1)
Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg
Strasbourg
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.09.2026
Completion date
01.03.2027
Registry ID
NCT07545928
Source
clinicaltrials.gov
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