Palliative CareEPURAVASNCT07214090
Pilot Study Evaluating the Therapeutic Effects of Passive Exposure Virtual Reality on Pain, Anxiety, Fatigue, and Well-being in Patients With Complex Palliative Care Needs.
An observational study of Palliative Care, run by University Hospital, Strasbourg, France.
Trial summary
The EPURAVAS "Pilot Study Using Augmented and Virtual Reality to Ease Suffering in Palliative Care" study is designed to investigate a non-medication treatment for complex symptoms in palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT) and Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 May 2026
- Phase
- Observational
- 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
Study population: Study participants will be recruited from the palliative care unit or through the mobile palliative care team at Strasbourg University Hospitals.
Who may be able to join
- Patient ≥ 18 years old
- Hospitalized in the palliative care unit or followed by the mobile palliative care team of the Strasbourg University Hospitals
- Estimated life expectancy > 1 month (Pronopall score calculated based on medical record data)
- Affiliated with a social security scheme
- Able to understand the objectives and risks of the trial
- Able to understand and complete study questionnaires written in French
- Reachable by phone or email for the entire duration of participation in the study
Who cannot join
- Patient with a psychotic mental illness, followed and treated before the study, and not stabilized
- Patient with a severe neurological disease, followed and treated before the study, and not stabilized
- Patient with visual or auditory disorders, or motion sickness, present before the study, that could interfere with the use of virtual reality
- Patient under legal protection or unable to express their consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Single-center, Randomized, Controlled Study Evaluating the Therapeutic Effects of Passive Exposure Virtual Reality on Pain, Anxiety, Fatigue, and Well-being in Patients With Complex Palliative Care Needs.
The EPURAVAS "Pilot Study Using Augmented and Virtual Reality to Ease Suffering in Palliative Care" study is designed to investigate a non-medication treatment for complex symptoms in palliative care.
The purpose is to assess the clinical effectiveness of Virtual Reality (VR) exposure as a way to relieve the distressing symptoms experienced by individuals receiving specialized palliative care.
Read more
The study seeks to determine if immersive Passive Exposure Virtual Reality (RVEP) is more effective at providing a significant reduction in pain and anxiety, and a greater overall improvement in well-being and quality of life for patients in complex palliative situations, compared to a control virtual reality approach.
In the study, individuals are randomly assigned to one of two groups for a week:
- Immersive VR: A headset completely surrounds the user in a calming, computer-generated world, aiming to deeply distract the mind from discomfort.
- Control VR: A different headset allows the user to still see the real room while potentially having some virtual elements added. This acts as a comparison to measure the specific benefits of the deep immersion.
Participation involves daily 10-minute VR sessions for seven days. Throughout this time, physiological measurements are safely and continuously recorded using the VR headset and a connected watch. This collects objective information on how the body is reacting-things like brain activity, heart rate, and breathing-to scientifically determine the treatment's impact.
- Conditions
- Palliative Care
- Being tested
- Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT), Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)
- Keywords
- Palliative care, Virtual Reality Exposure Therapy, Virtual Reality, Pain modulation, Clinical Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT)Behavioural
This intervention uses a transparent augmented virtual reality headset equipped with forward-facing cameras that capture the patient's real-world environment in real time. Transparent virtual and augmented reality overlays computer-generated elements (e.g., visual cues, guidance, or interactive content) onto the live view of the physical environment. This approach maintains a strong anchoring in reality while providing therapeutic visual enhancements, tailored in real-time to the patient's responses. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff.
Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)Behavioural
This intervention involves the use of a head-mounted display to immerse the patient in a fully computer-generated virtual environment. The virtual reality passive exposure is designed to distract patients from painful or anxiety-inducing sensations by engaging multiple sensory modalities (visual, auditory, and occasionally tactile). Patients are exposed to relaxing or engaging scenarios, such as natural landscapes or calm immersive scenes, without requiring interaction. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff.
| Study group | Role | What they receive |
|---|---|---|
| RVAT | The RVAT group serves as the control against which the experimental RVEP method is measured. Individuals in this group use a headset that is designed to be transparent or augmented, allowing them to remain aware of and oriented to their actual environment-the room they are in. While they may see some minimal virtual elements, there is no escape or full immersion into an alternative reality. Receives: Behavioral: Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT) | |
| RVEP | Individuals in this group use a VR headset that creates a full sensory immersion, meaning the real world is completely blocked out. The experience involves being transported into calming, computer-generated environments, such as tranquil nature scenes. The goal of this full immersion is to achieve a deep, passive distraction that effectively shifts attention away from symptoms like pain and anxiety. Receives: Behavioral: Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Effectiveness Assessed by ESAS F12 Pain Score
Clinical effectiveness of the RVEP and RVAT interventions will be evaluated using the ESAS F12 questionnaire. A clinically significant improvement is defined as a reduction of at least 2 points on the numeric pain scale between Day 0 and Day 7. Each subject will be classified as "effective" (yes/no) based on this criterion, allowing comparison of effectiveness percentages between groups.
Measured: Day 0 (J0) to Day 7 (J7)
Secondary outcomes (11)
Presence of Pain Assessed by EEG
Pain presence will be evaluated using EEG recordings during each session. A pain episode is defined as Piq ≥10%. This outcome assesses the physiological signal of pain during RVEP and RVAT sessions.
Measured: During each session from Day 0 to Day 7
Pain Experience Assessed by the French Short Version of the Brief Pain Inventory (QCD in french, or BPI in english)
Pain experience will be tracked using the BPI questionnaire to evaluate changes in the subjective experience of pain from baseline through Day 14.
Certainly, here is a brief description of the three assessment scales you've asked about:
The BPI is a comprehensive, self-report tool designed to assess both the intensity of a patient's pain and the degree to which that pain interferes with their daily life. The patient uses a 0 to 10 scale to rate pain severity (e.g., worst, least, and average pain) and the impact on seven different activities (like mood, walking, and sleep). The BPI is typically analyzed as two separate average scores-Pain Severity and Pain Interference-to provide a clear picture of the pain's physical and functional dimensions. Higher scores indicate a worse outcome, meaning more intense pain or greater functional interference.
Measured: Before the first session, Day 7 (J7), and Day 14 (J14)
Dropout and Exclusion Rate
The percentage of participants lost to follow-up or excluded during the study will be calculated in order to assess protocol feasibility and support future sample size calculations for comparative studies.
Measured: Day 0 to Day 14
Emotional and Functional Outcomes - Objective Physiological Data
Physiological data will be collected from EEG (electroencephalography) via KAPTICS© headset, and Embrace Plus© smartwatches to assess functional and emotional responses to RV interventions.
EEG measures the electrical activity of the brain. The raw data is recorded as voltage fluctuations over time.
Measured: Continuously during each session from Day 0 to Day 7
Discomfort Symptoms Assessed by ESAS F12
The ESAS F12 ( Edmonton Symptom Assessment System) questionnaire will be used to assess self-reported symptoms of discomfort before and after each session.
Minimum Value: The minimum possible score is 0. Maximum Value: The maximum possible score is 120. Interpretation of Scores: Higher scores mean a worse outcome or greater severity of the symptom. A score of 0 means the symptom is absent ("no pain," "not tired"), and a score of 120 means the symptom is at its "worst possible severity."
Measured: Before and after each session from Day 0 to Day 7
Anxiety Symptoms Assessed by HADS-A
Anxiety levels will be measured using the anxiety subscore ("A") of the Hospital Anxiety and Depression Scale (HADS) to evaluate changes in emotional state throughout the intervention period.
Scores on the HADS scale (Hospital Anxiety and Depression Scale) for anxiety symptoms. Structure: 14 items total, split into two subscales: - HADS-A (Anxiety) - 7 items - HADS-D (Depression) - 7 items Minimum value: 0 (no symptoms). Maximum value: 21 per subscale (if all items scored at the maximum of 3). but 42 total if both subscales are summed. Interpretation: Higher scores reflect a worse outcome, meaning greater anxiety and/or depressive symptom severity.
Measured: Before and after each session until Day 7, and again at Day 14
Well-Being Assessed by WHO-5 Well-Being Index (OMS-5 in french)
Subjective well-being will be assessed using the WHO-5 questionnaire to track changes in psychological health over time.
The WHO-5 Well-Being Index is a short, simple questionnaire that measures a person's current mental well-being and is primarily used to screen for depression.
This scale consists of just five questions that ask the patient to rate how often they have felt a certain way over the past two weeks (e.g., cheerful, calm, full of energy). Each item is scored on a scale from 0 (at no time) to 5 (all the time). The total raw score is calculated by summing the five item scores, which is then multiplied by four to create a final score between 0 and 100.
Measured: Day 0 (J0), Day 7 (J7), and Day 14 (J14)
Fatigue Assessed by the Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 questionnaire will evaluate multidimensional fatigue to assess physical and mental fatigue trajectories throughout the study.
The MFI-20 questionnaire is the Multidimensional Fatigue Inventory. Minimum Value (per subscale): 4 Maximum Value (per subscale): 20 The MFI-20 is composed of five subscales (General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue), each with a score range of 4 to 20. The use of a single total score over all 20 items is generally not recommended. Higher scores on the MFI-20 reflect more severe or greater fatigue, meaning a worse outcome.
Measured: Day 0 (J0), Day 7 (J7), and Day 14 (J14)
Tolerance of VR Exposure - Cybersickness Symptoms
Cybersickness symptoms will be monitored using the VRISE-fr scale to evaluate tolerance to virtual reality exposure during the intervention.
The "VRISE-fr" scale stands for Virtual Reality-Induced Symptoms and Effects (French adaptation).
Minimum Value: 0 (No symptoms). Maximum Value: 35 Interpretation: Higher scores mean a worse outcome (greater severity of symptoms/sickness).
Measured: Before and after each session from Day 0 to Day 7
Subjective Experience of Intervention - Semi-Structured Interview
A semi-structured interview will be conducted using a guide with five open-ended questions to qualitatively assess the participant's experience and perception of the intervention.
Measured: Day 14 (J14)
Emotional and Functional Outcomes - Objective Physiological Data
Physiological data will be collected from EOG (electrooculography) via KAPTICS© headset, and Embrace Plus© smartwatches to assess functional and emotional responses to RV interventions.
The EOG data is primarily used to track and quantify eye movements
Measured: Continuously during each session from Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214090
- Sponsor's protocol ID
- 9787
- Acronym
- EPURAVAS
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Single-center, Randomized, Controlled Study Evaluating the Therapeutic Effects of Passive Exposure Virtual Reality on Pain, Anxiety, Fatigue, and Well-being in Patients With Complex Palliative Care Needs.
- ClinicalTrials.gov ID
- NCT07214090
- Acronym / sponsor ID
- EPURAVAS / 9787
- Conditions
- Palliative Care
- Keywords
- Palliative care, Virtual Reality Exposure Therapy, Virtual Reality, Pain modulation, Clinical Efficacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 9 Oct 2025 (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.
The EPURAVAS "Pilot Study Using Augmented and Virtual Reality to Ease Suffering in Palliative Care" study is designed to investigate a non-medication treatment for complex symptoms in palliative care.
The purpose is to assess the clinical effectiveness of Virtual Reality (VR) exposure as a way to relieve the distressing symptoms experienced by individuals receiving specialized palliative care.
The study seeks to determine if immersive Passive Exposure Virtual Reality (RVEP) is more effective at providing a significant reduction in pain and anxiety, and a greater overall improvement in well-being and quality of life for patients in complex palliative situations, compared to a control virtual reality approach.
In the study, individuals are randomly assigned to one of two groups for a week:
- Immersive VR: A headset completely surrounds the user in a calming, computer-generated world, aiming to deeply distract the mind from discomfort.
- Control VR: A different headset allows the user to still see the real room while potentially having some virtual elements added. This acts as a comparison to measure the specific benefits of the deep immersion.
Participation involves daily 10-minute VR sessions for seven days. Throughout this time, physiological measurements are safely and continuously recorded using the VR headset and a connected watch. This collects objective information on how the body is reacting-things like brain activity, heart rate, and breathing-to scientifically determine the treatment's impact.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVAT | – | Behavioral: Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT)The RVAT group serves as the control against which the experimental RVEP method is measured. Individuals in this group use a headset that is designed to be transparent or augmented, allowing them to remain aware of and oriented to their actual environment-the room they are in. While they may see some minimal virtual elements, there is no escape or full immersion into an alternative reality. |
| RVEP | – | Behavioral: Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)Individuals in this group use a VR headset that creates a full sensory immersion, meaning the real world is completely blocked out. The experience involves being transported into calming, computer-generated environments, such as tranquil nature scenes. The goal of this full immersion is to achieve a deep, passive distraction that effectively shifts attention away from symptoms like pain and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the palliative care unit or through the mobile palliative care team at Strasbourg University Hospitals.
Key inclusion criteria (7 listed)
- Patient ≥ 18 years old
- Hospitalized in the palliative care unit or followed by the mobile palliative care team of the Strasbourg University Hospitals
- Estimated life expectancy > 1 month (Pronopall score calculated based on medical record data)
- Affiliated with a social security scheme
- Able to understand the objectives and risks of the trial
Key exclusion criteria (4 listed)
- Patient with a psychotic mental illness, followed and treated before the study, and not stabilized
- Patient with a severe neurological disease, followed and treated before the study, and not stabilized
- Patient with visual or auditory disorders, or motion sickness, present before the study, that could interfere with the use of virtual reality
- Patient under legal protection or unable to express their consent
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 |
|---|---|---|
| Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT)This intervention uses a transparent augmented virtual reality headset equipped with forward-facing cameras that capture the patient's real-world environment in real time. Transparent virtual and augmented reality overlays computer-generated elements (e.g., visual cues, guidance, or interactive content) onto the live view of the physical environment. This approach maintains a strong anchoring in reality while providing therapeutic visual enhancements, tailored in real-time to the patient's responses. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff. | Behavioural | RVAT |
| Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)This intervention involves the use of a head-mounted display to immerse the patient in a fully computer-generated virtual environment. The virtual reality passive exposure is designed to distract patients from painful or anxiety-inducing sensations by engaging multiple sensory modalities (visual, auditory, and occasionally tactile). Patients are exposed to relaxing or engaging scenarios, such as natural landscapes or calm immersive scenes, without requiring interaction. Sessions last 10 minutes and are delivered in a controlled clinical environment, supervised by trained staff. | Behavioural | RVEP |
Primary outcome
Clinical Effectiveness Assessed by ESAS F12 Pain Score
Time frame: Day 0 (J0) to Day 7 (J7)
Clinical effectiveness of the RVEP and RVAT interventions will be evaluated using the ESAS F12 questionnaire. A clinically significant improvement is defined as a reduction of at least 2 points on the numeric pain scale between Day 0 and Day 7. Each subject will be classified as "effective" (yes/no) based on this criterion, allowing comparison of effectiveness percentages between groups.
11 secondary outcomes
Presence of Pain Assessed by EEG
Time frame: During each session from Day 0 to Day 7
Pain Experience Assessed by the French Short Version of the Brief Pain Inventory (QCD in french, or BPI in english)
Time frame: Before the first session, Day 7 (J7), and Day 14 (J14)
Dropout and Exclusion Rate
Time frame: Day 0 to Day 14
Emotional and Functional Outcomes - Objective Physiological Data
Time frame: Continuously during each session from Day 0 to Day 7
Discomfort Symptoms Assessed by ESAS F12
Time frame: Before and after each session from Day 0 to Day 7
Anxiety Symptoms Assessed by HADS-A
Time frame: Before and after each session until Day 7, and again at Day 14
Well-Being Assessed by WHO-5 Well-Being Index (OMS-5 in french)
Time frame: Day 0 (J0), Day 7 (J7), and Day 14 (J14)
Fatigue Assessed by the Multidimensional Fatigue Inventory (MFI-20)
Time frame: Day 0 (J0), Day 7 (J7), and Day 14 (J14)
Tolerance of VR Exposure - Cybersickness Symptoms
Time frame: Before and after each session from Day 0 to Day 7
Subjective Experience of Intervention - Semi-Structured Interview
Time frame: Day 14 (J14)
Emotional and Functional Outcomes - Objective Physiological Data
Time frame: Continuously during each session from Day 0 to Day 7
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 9 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by University Hospital, Strasbourg, 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 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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, Pr (+33388128339, 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?
Clinical Effectiveness Assessed by ESAS F12 Pain Score (time frame: Day 0 (J0) to Day 7 (J7)). 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 9 Oct 2025.