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| Name | Class |
|---|---|
| Moholy-Nagy University of Art and Design | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive Virtual Reality (VR) Intervention | Experimental | Participants receive a daily 10-minute session of the "ZenctuaryVR+" interactive virtual reality program for 14 consecutive days. Unlike passive VR, this intervention allows patients to interact with a calming natural environment via a Head-Mounted Display (HMD) and hand controllers to support autonomy and provide distraction from refractory symptoms. The intervention is supervised by trained clinical staff who perform a daily bedside "go/no-go" assessment. It is administered as a non-pharmacological supportive care tool alongside standard palliative treatments to evaluate the feasibility, safety, and impact of interactive VR on pain, anxiety, and overall quality of life. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Success : Adherence | The participant must complete at least 11 out of the 14 planned daily interactive VR sessions. | During the 14-day intervention period. |
| Feasibility Success : Duration | The mean duration of all completed sessions (J1 through J14) must be ≥ 7.5 minutes. | 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. | 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 | Assessed daily, immediately following each VR session, over the 14-day period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent CALVEL, PU-PH | Contact | +33(0)6.28.07.12.74 | +33 | laurent.calvel@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
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|
|
| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D001008 | Anxiety Disorders |
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D005221 | Fatigue |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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