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.
NCT ID: NCT07214090
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-10-01
2026-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Reality for Symptoms Control in Palliative Care
NCT03698526
Virtual Reality at End-of-life
NCT06149429
Bringing Life to Those Near Death
NCT05466123
Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit
NCT04966260
Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care
NCT04138095
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9787
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.