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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Clinical Effectiveness Assessed by ESAS F12 Pain Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical Effectiveness Assessed by ESAS F12 Pain Score
时间窗: Day 0 (J0) to Day 7 (J7)
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.
次要结局
- 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)
- Anxiety Symptoms Assessed by HADS-A(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)(Day 0 (J0), Day 7 (J7), and Day 14 (J14))
- Fatigue Assessed by the Multidimensional Fatigue Inventory (MFI-20)(Day 0 (J0), Day 7 (J7), and Day 14 (J14))
- Tolerance of VR Exposure - Cybersickness Symptoms(Before and after each session from Day 0 to Day 7)
- Subjective Experience of Intervention - Semi-Structured Interview(Day 14 (J14))