Multi-sensory Intervention Room Application (MIRA) Device in the NSICU
- Conditions
- Post Intensive Care Syndrome
- Interventions
- Device: MIRA
- Registration Number
- NCT06509815
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MIRA in the NSICU MIRA The Intervention arm will experience the device, MIRA, during their stay in the NSICU.
- Primary Outcome Measures
Name Time Method Acceptability of Intervention Measure (AIM) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Type of pain medication administration daily, average 4 days in ICU Categorical information on the type of medication administered (sedatives, analgesics, anti-seizure medications, anti-hypertensives, pressors, antibiotics, antipsychotics, other)
Patient Health Questionnaire 9 (PHQ9) Scale Score Up to 6 months The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to assess depression severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Response to noxious stimuli and/or touch Up to 6 months Neurological assessment used to assess sensory status. Sensory status notes if the patient responds to noxious stimuli or not.
Generalized Anxiety Disorder 7 Scale Score Up to 6 months The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess self-reported anxiety symptoms. Total GAD-7 score ranges from a minimum of 0 (no anxiety) to a maximum of 21 (severe anxiety), with higher scores indicating greater anxiety severity.
Intubated pain measured using Critical Care Pain Observation Tool daily, average 4 days in ICU The Critical Care Pain Observation Tool (CCPOT) is an 8-item measure used to assess self-reported pain levels in intubated, critically ill patients who cannot self-report. Total CCPOT score ranges from a minimum of 0 (no pain behaviors observed) to a maximum of 8 (significant behaviors indicating severe pain), with higher scores indicating higher pain levels in intubated patients.
Patient Health Questionnaire 2 (PHQ2) Scale Score Up to 6 months The Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool used to assess depressed mood and anhedonia to screen for depression. PHQ-2 scores range from 0 to 6, with higher scores suggesting a higher likelihood of depression requiring further evaluation with the longer PHQ-9.
Motor Status Up to 6 months Neurological assessment used to asses motor status. Motor strength is ranked 0-5 (5 meaning full function) for both upper and lower extremities.
Insomnia Severity Index to measure sleep quality Up to 6 months The Insomnia Severity Index (ISI) is a 7-item questionnaire used to assess perceived insomnia severity. ISI scores range from 0 to 28, with higher scores indicating more severe levels of insomnia.
Non-intubated pain measured using Pain Scale daily, average 4 days in ICU The Pain Scale is used to assess self-reported pain levels in critically ill patients who are not intubated and can self-report pain. Total score on the Pain Scale ranges from a minimum of 0 (no pain) to a maximum of 10 (worst/most severe pain), with higher scores indicating more intense pain levels in non-intubated patients.
Awareness of person, place, and time Up to 6 months Neurological assessment used to assess mental status. Mental status checks if a person has awareness of person, place, and time.
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States