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.

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.

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.

Interventions

• Behavioral 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 respo
• Behavioral 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

Primary outcome measures

• Clinical Effectiveness Assessed by ESAS F12 Pain Score [Time frame: Day 0 (J0) to Day 7 (J7)]

Secondary outcome measures (11)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07214090 · 9787

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗