Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
研究概览
简要总结
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.
The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.
详细描述
After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 aged ≥ 18 years.
- •Haematological pathology
- •Patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils <0.5 G / L.
- •Patient having signed his informed consent.
- •Patient with social security coverage.
- •Patient treated and monitored in the center for the duration of the study (maximum 1 month)
排除标准
- •Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
- •Patient deprived of his liberty or under guardianship.
- •Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
- •Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).
结局指标
主要结局
Compare the change in anxiety in the HYPNOVR group versus the change in anxiety in the "selected activity" control group.
时间窗: For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.
Comparison of the change in the anxiety "state" by the State Trait Anxiety Inventory (STAI) - State score before (15 minutes) and after (15 minutes) each virtual reality hypnosis session for 3 consecutive days (ie six questionnaires) to the change in the anxiety "state" in patients in the control group (STAI-State score evaluated 15 minutes before and 15 minutes after the patient was offered an activity of his choice). The score is a quantitative variable with values ranging from 20 to 80. The higher the score is, the more important the anxiety is.
次要结局
- Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a variation of the chronic pain (in comparision with a control group).(For up to 3 days, every days (before and after the virtual reality hypnosis sessions), starting on day of inclusion.)
- Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of analgesic treatments (in comparision with a control group).(For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.)
- Test the hypothesis that medical hypnosis in virtual reality is accompanied by a modification in the consumption of anxiolytics treatments (in comparision with a control group).(For up to 3 days, every days (record before the virtual reality hypnosis sessions), starting on day of inclusion.)
- Test the hypothesis that medical hypnosis in virtual reality is accompagnied by a good patient satisfaction regarding the use of the virtual reality headset.(For up to 3 days, every days (record after the virtual reality hypnosis sessions), starting on day of inclusion.)