Immersive Sensory Projections: Evaluating the Impact of an Immersive Sensory Environment (Visual, Auditory and Olfactory) on Reducing the Overall Discomfort of Patients Hospitalized in the Resuscitation and Continuing Care Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- REAnimation Patient Discomfort Questionnaire
研究概览
简要总结
The purpose of this study is to assess the impact of adding three sensory elements (visual, auditory, olfactory) on reducing discomfort in patients hospitalized in the intensive care unit/continuing care unit.
详细描述
The IHP trial is multicenter, interventional, prospective, randomized, controlled, open-label study.
The study population consists of adult patients hospitalized in an intensive care or continuing care unit for medical or surgical reasons, conscious or unconscious under mechanical ventilation.
All patients participating in the study will be managed according to usual practices in intensive care and continuing care units. All patients and their relatives will be monitored and supported by the medical team as in normal practice.
The study will be offered to the patient or a close relative/trusted person on admission to hospital.
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
盲法说明
Open-label study
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
- •Age ≥ 18 years ;
- •Patient hospitalized in intensive care or continuing care unit for an estimated minimum of 48 hours;
- •Patient hospitalized for a medical indication (including in the pre-surgical phase) or in the post-surgical phase;
- •Patient or support person who speaks and understands French, has understood the research procedures and is able to complete the questionnaires;
- •For women of childbearing age (non-menopausal), even for those on contraception: negative pregnancy test (urinary); If positive: completed by a biological test;
- •Patient or trusted support person having been informed and having signed an informed consent form to participate in the study.
排除标准
- •Deaf or blind patient;
- •Asthmatic patient with background treatment;
- •Epileptic patient or known history of convulsion;
- •Known allergy or intolerance to essential oils or to a component of essential oils;
- •Patient transferred from another intensive care unit;
- •Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- •Breast-feeding or pregnant women;
- •Patient or support person unable to understand information relating to the study (linguistic, psychological, cognitive, etc.);
- •Unconscious patient with no relative or support person present;
- •Homeless patient;
- •Patient with known severe psychiatric illness such as chronic hallucinatory psychosis or paranoid syndrome;
- •Patient participating in or being excluded from another clinical trial;
- •Patient not covered by a social security scheme.
研究组 & 干预措施
Immersive sensory projections
Patients will benefit from an immersive sensory environment in the hospital room. This IHP immersive sensory environment consists of the following elements:
- light frescoes on the theme of nature, of the canopy type, diffused by a generative circadian cycle.
- a soundtrack made up of nature sounds and sounds of life outside the hospital, broadcast in an immersive (moving sounds in the room), random (non-repetitive sounds over time) and generative way.
- essential oils
干预措施: Hospitalization in intensive care or continuing care unit (Procedure)
No immersive sensory projections
Standard (control) group: Patients will not have any Immersion Health Project-type immersive sensory projection in the hospital room.
干预措施: Hospitalization in intensive care or continuing care unit (Procedure)
结局指标
主要结局
REAnimation Patient Discomfort Questionnaire
时间窗: 2 months
Overall score on the REAnimation Patient Discomfort Questionnaire at the end-of-study visit
次要结局
未报告次要终点