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.

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.

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.

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.

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.

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.

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."

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.

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.

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.

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).

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.

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