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Not yet recruitingNCT07545928ZENCTUARY_VR+Updated Apr 22, 2026

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

An interventional study of ZenctuaryVR+ Interactive Virtual Reality in Palliative Care, Refractory Pain and Anxiety, sponsored by University Hospital, Strasbourg, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).
02

Conditions studied

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

Keywords

  • palliative care
  • end-of-life care
  • refractory pain
  • Interactive Virtual Reality
  • Immersive Technology
  • Virtual Reality Exposure Therapy (VRET)
  • Cybersickness in Palliative Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Device: ZenctuaryVR+ Interactive Virtual Reality

Interventions

  • DeviceZenctuaryVR+ 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 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.

    Also known as: ZenctuaryVR+

05

What researchers measure

Primary outcomes

  1. Feasibility Success : Adherence

    The participant must complete at least 11 out of the 14 planned daily interactive VR sessions.

    Time frame: During the 14-day intervention period.

  2. Feasibility Success : Duration

    The mean duration of all completed sessions (J1 through J14) must be ≥ 7.5 minutes.

    Time frame: Calculated at the end of the 14-day period

  3. Feasibility Success : Safety

    Continuous monitoring for any serious adverse events definitely or probably related to the device throughout the entire study duration.

    Time frame: From Day 1 (first VR exposure) to Day 14 (final session).

  4. 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

    Time frame: Assessed daily, immediately following each VR session, over the 14-day period.

06

Study locations

1 site
  • Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07545928
Lead sponsor
University Hospital, Strasbourg, France
Collaborators
Moholy-Nagy University of Art and Design
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Laurent CALVEL, PU-PH
Contact
laurent.calvel@chru-strasbourg.fr
+33(0)6.28.07.12.74 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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