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

NCT07545928 | Not Yet Recruiting

• 1 other identifier: RC26_0121
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Palliative Care; Anxiety; Refractory Pain; 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

Outcome Measures

Primary Outcomes (4)

• Feasibility Success : Adherence

  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

  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

  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

  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.

Study Arms (1)

Interactive Virtual Reality (VR) Intervention

EXPERIMENTAL

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

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.

Also known as: ZenctuaryVR+

Interactive Virtual Reality (VR) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• MOME, University of Arts and Design: collaborator

Study Sites (1)

Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pain, Intractable; Anxiety Disorders; Mental Fatigue

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Fatigue; Behavioral Symptoms; Behavior

Central Study Contacts

Laurent CALVEL, PU-PH

CONTACT

+33(0)6.28.07.12.74; laurent.calvel@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)