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.

N/ANot Yet RecruitingNCT07214090

University Hospital, Strasbourg, France40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Palliative Care

Interventions

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)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: Day 0 (J0) to Day 7 (J7)

Secondary Outcomes

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.

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)

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.

Time frame: 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.

Time frame: 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.

Time frame: 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."

Time frame: 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.

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)

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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: Day 14 (J14)