Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients
Starting soon · Not applicable
Conditions studied: Palliative Care, Refractory Pain, Anxiety, Depression Disorders, Fatigue, Mental, Psychological Distress
In brief
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).
Key facts
- Study ID
- NCT07545928
- Run by
- University Hospital, Strasbourg, France
- People needed
- 20
- Starts
- 2026-09-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg — Strasbourg, France
Full record on ClinicalTrials.gov
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