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

April 15, 2026 updated by: University Hospital, Strasbourg, France

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Sub-Investigator:
          • Daphné PRIEUR-DREVON, CCU-AH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.

Other Names:
  • ZenctuaryVR+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Success : Adherence
Time Frame: During the 14-day intervention period.
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
Time Frame: Calculated at the end of the 14-day period
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
Time Frame: From Day 1 (first VR exposure) to Day 14 (final session).
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
Time Frame: Assessed daily, immediately following each VR session, over the 14-day period.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

MOME, University of Arts and Design

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC26_0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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