Multi-sensory Intervention Room Application (MIRA) Device in the NSICU
NCT Number: NCT06509815
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Intensive Care Syndrome
Interventions: DEVICE: MIRA
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2024-12

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.

Primary Outcome Measures: Acceptability of Intervention Measure (AIM), 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., Within 2 days of the device used in the patient room during stay in ICU|Intervention Appropriateness Measure (IAM), 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., Within 2 days of the device used in the patient room during stay in ICU|Feasibility of Intervention Measure (FIM), 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., Within 2 days of the device used in the patient room during stay in ICU
Secondary Outcome Measures: Intubated pain measured using Critical Care Pain Observation Tool, 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., daily, average 4 days in ICU|Non-intubated pain measured using Pain Scale, 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., daily, average 4 days in ICU|Type of pain medication administration, Categorical information on the type of medication administered (sedatives, analgesics, anti-seizure medications, anti-hypertensives, pressors, antibiotics, antipsychotics, other), daily, average 4 days in ICU|Generalized Anxiety Disorder 7 Scale Score, 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., Baseline, Day 0|Generalized Anxiety Disorder 7 Scale Score, 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., At Discharge, approximately 4 days|Generalized Anxiety Disorder 7 Scale Score, 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., Up to 6 months|Patient Health Questionnaire 2 (PHQ2) Scale Score, 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., Baseline, Day 0|Patient Health Questionnaire 2 (PHQ2) Scale Score, 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., At Discharge, approximately 4 days|Patient Health Questionnaire 2 (PHQ2) Scale Score, 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., Up to 6 months|Patient Health Questionnaire 9 (PHQ9) Scale Score, 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., Baseline, Day 0|Patient Health Questionnaire 9 (PHQ9) Scale Score, 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., At Discharge, approximately 4 days|Patient Health Questionnaire 9 (PHQ9) Scale Score, 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., Up to 6 months|Awareness of person, place, and time, Neurological assessment used to assess mental status. Mental status checks if a person has awareness of person, place, and time., Up to 6 months|Motor Status, Neurological assessment used to asses motor status. Motor strength is ranked 0-5 (5 meaning full function) for both upper and lower extremities., Up to 6 months|Response to noxious stimuli and/or touch, Neurological assessment used to assess sensory status. Sensory status notes if the patient responds to noxious stimuli or not., Up to 6 months|Insomnia Severity Index to measure sleep quality, 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., Up to 6 months