Palliative CareZENCTUARY_VR+NCT07545928
Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients
A study testing ZenctuaryVR+ Interactive Virtual Reality in people with Palliative Care and Refractory Pain, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Refractory Pain, Anxiety
- What is being tested?
- ZenctuaryVR+ Interactive Virtual Reality
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Laurent CALVEL, PU-PH, +33(0)6.28.07.12.74 ext. +33, laurent.calvel@chru-strasbourg.fr
Daphné PRIEUR-DREVON, CCU-AH
About this study
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, Refractory Pain, Anxiety, Depression Disorders, Fatigue, Mental, Psychological Distress
- Being tested
- ZenctuaryVR+ Interactive Virtual Reality
- Keywords
- palliative care, end-of-life care, refractory pain, Interactive Virtual Reality, Immersive Technology, Virtual Reality Exposure Therapy (VRET), Cybersickness in Palliative Care
- Medical subject headings
- Pain, Intractable, Anxiety Disorders, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenctuaryVR+ Interactive Virtual RealityDevice
Also called ZenctuaryVR+
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ZenctuaryVR+ Interactive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Success : Adherence
The participant must complete at least 11 out of the 14 planned daily interactive VR sessions.
Measured: During the 14-day intervention period.
Feasibility Success : Duration
The mean duration of all completed sessions (J1 through J14) must be ≥ 7.5 minutes.
Measured: 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.
Measured: 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
Measured: Assessed daily, immediately following each VR session, over the 14-day period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Moholy-Nagy University of Art and Design
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545928
- Sponsor's protocol ID
- RC26_0121
- Acronym
- ZENCTUARY_VR+
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients
- ClinicalTrials.gov ID
- NCT07545928
- Acronym / sponsor ID
- ZENCTUARY_VR+ / RC26_0121
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Moholy-Nagy University of Art and Design
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interactive Virtual Reality (VR) Intervention | Experimental | Device: ZenctuaryVR+ Interactive Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZenctuaryVR+ Interactive Virtual RealityAlso: ZenctuaryVR+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. | Device | Interactive Virtual Reality (VR) Intervention |
Primary outcome
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZenctuaryVR+ Interactive Virtual Reality in people with Palliative Care and Refractory Pain, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent CALVEL, PU-PH (+33(0)6.28.07.12.74 ext. +33, laurent.calvel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Success : Adherence (time frame: During the 14-day intervention period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.