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NCT Number: NCT07545928

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

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).

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Key information

Conditions

Palliative Care Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Disorders Fatigue Fatigue, Mental Mental Disorders Mental Fatigue Neurologic Manifestations Pain Pain, Intractable Pathological Conditions, Signs and Symptoms Psychological Distress Refractory Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location contact

Daphné PRIEUR-DREVON, CCU-AH

SUB_INVESTIGATOR

Laurent CALVEL, PU-PH

CONTACT

[email protected]

+33(0)6.28.07.12.74 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ZenctuaryVR+

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent CALVEL, PU-PH

CONTACT

[email protected]

+33(0)6.28.07.12.74 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Collaborators

  • Moholy-Nagy University of Art and Design

Registry information

Acronym: ZENCTUARY_VR+

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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