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

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT07545928
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression Disorders
  • Fatigue, Mental
  • Palliative Care
  • Psychological Distress
  • Refractory Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

First listed
Apr 22, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Interactive Virtual Reality (VR) Intervention
    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.

Primary Outcome Measure

Feasibility Success : Adherence [ Time Frame: During the 14-day intervention period. ]

Central Contacts

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