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Not yet recruiting NCT07545928

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

No phase Interventional Palliative Care Refractory Pain Anxiety Depression Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZenctuaryVR+ Interactive Virtual Reality.
Who it may be relevant to
Registry conditions: Palliative Care, Refractory Pain, Anxiety, Depression Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Interventions

  • Device ZenctuaryVR+ Interactive Virtual Reality
    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 da

Primary outcome measures

  • Feasibility Success : Adherence [Time frame: During the 14-day intervention period.]
  • Feasibility Success : Duration [Time frame: Calculated at the end of the 14-day period]
  • Feasibility Success : Safety [Time frame: From Day 1 (first VR exposure) to Day 14 (final session).]
  • Feasibility Success : Tolerance [Time frame: Assessed daily, immediately following each VR session, over the 14-day period.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT07545928 · RC26_0121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗