Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
The purpose of this research study is to determine the safety, feasibility, and efficacy of a device, MIRA, on the physical, mental, and cognitive health of Neurosciences Intensive Care Unit (NSICU) patients.
The study device is a Multi-Sensory Stimulation Device named MIRA, which uses commercially available hardware and builds off the SOLUNA software created by Studio Elsewhere, which produces audio and visual immersive experiences. The current device, Model M1, is a prototype developed for sole investigational purposes of this study and is not commercially available.
Participants, who will be patients and staff of the NSICU, will complete questionnaires regarding safety, feasibility, and efficacy. The research team will enroll 20 patient and 15 staff participants. The trial is expected to last 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •For NSICU Staff:
- •Current employee at NSICU
- •Aged >/= 18
- •For NSICU Patients:
- •Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
- •Provision of signed and dated informed consent form (ICF)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged >/= 18
- •Any sex or gender identity
- •Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
- •Exclusion Criteria
- •Not a Mount Sinai NSICU patient
- •No LAR present and unable to consent
排除标准
- 未提供
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: Within 2 days of the device used in the patient room during stay in ICU
Implementation success will be assessed using the Acceptability of Intervention Measure (AIM). AIM is a 4-item measure used to determine the extent to which stakeholders (e.g., parents, providers, administrators) believe an intervention or implementation strategy is acceptable. Total score ranges from a minimum score 4 (unacceptable) to a maximum score 20 (very acceptable), with higher scores indicating greater acceptability of the intervention.
Feasibility of Intervention Measure (FIM)
时间窗: Within 2 days of the device used in the patient room during stay in ICU
Implementation success will be assessed using the Feasibility of Intervention Measure (FIM). FIM is a 4-item measure used to determine the extent to which an intervention or implementation strategy is feasible to implement. Total score ranges from a minimum of 4 (not feasible) to a maximum of 20 (very feasible), with higher scores indicating greater perceived feasibility of the intervention strategy being evaluated.
Intervention Appropriateness Measure (IAM)
时间窗: Within 2 days of the device used in the patient room during stay in ICU
Implementation success will be assessed using the Intervention Appropriateness Measure (IAM). IAM is a 4-item measure used to determine the extent to which stakeholders (e.g. parents, providers, administrators) believe an intervention or implementation strategy is appropriate or suitable for the situation. Total score ranges minimum 4 (unacceptable) to maximum 20 (very acceptable), with higher scores indicating greater appropriateness of the intervention strategy being evaluated.
次要结局
- Type of pain medication administration(daily, average 4 days in ICU)
- Patient Health Questionnaire 9 (PHQ9) Scale Score(Up to 6 months)
- Response to noxious stimuli and/or touch(Up to 6 months)
- Generalized Anxiety Disorder 7 Scale Score(Up to 6 months)
- Intubated pain measured using Critical Care Pain Observation Tool(daily, average 4 days in ICU)
- Patient Health Questionnaire 2 (PHQ2) Scale Score(Up to 6 months)
- Motor Status(Up to 6 months)
- Insomnia Severity Index to measure sleep quality(Up to 6 months)
- Non-intubated pain measured using Pain Scale(daily, average 4 days in ICU)
- Awareness of person, place, and time(Up to 6 months)
研究者
Neha Dangayach
Associate Professor
Icahn School of Medicine at Mount Sinai