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.

NCT07214090 | Not Yet Recruiting

• 1 other identifier: 9787
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Palliative Care

Keywords

Palliative care; Virtual Reality Exposure Therapy; Virtual Reality; Pain modulation; Clinical Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 (J0) to Day 7 (J7)

Secondary Outcomes (11)

• Presence of Pain Assessed by EEG

  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)

  Before the first session, Day 7 (J7), and Day 14 (J14)

• Dropout and Exclusion Rate

  Day 0 to Day 14

• Emotional and Functional Outcomes - Objective Physiological Data

  Continuously during each session from Day 0 to Day 7

• Discomfort Symptoms Assessed by ESAS F12

  Before and after each session from Day 0 to Day 7

Study Arms (2)

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.

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.

Behavioral: Passive Multisensory Virtual Reality Immersion via Head-Mounted Display (RVEP)

Interventions

Transparent Augmented Reality with Real-World Video Feed Overlay (RVAT) BEHAVIORAL

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.

RVAT

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.

RVEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be recruited from the palliative care unit or through the mobile palliative care team at Strasbourg University Hospitals.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Central Study Contacts

Laurent CALVEL, Pr

CONTACT

+33388128339; laurent.calvel@chru-strasbourg.fr

Daphné PRIEUR-DREVON, Dr

CONTACT

+33388116370; daphne.prieur-drevon@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10