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D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.
The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise & light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediation and Relaxation Intervention | Experimental | Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology based guided meditation and relaxation | Device | Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire | The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) | Immediately before and after each intervention Up to 7 days |
| Blood Pressure -Systolic | Alterations to vital signs allow for Non-Verbal Pain assessments | Immediately before and after each intervention up to 7 days |
| Heart Rate | Alterations to vital signs allow for Non-Verbal Pain assessments | Immediately before and after each intervention up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate | Alterations to vital signs allow for Non-Verbal Pain assessments | Entire ICU stay up to 7 days |
| Patient pain perception | Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters) |
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Inclusion Criteria:
Exclusion Criteria: The study team will exclude patients if:
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| Name | Affiliation | Role |
|---|---|---|
| Azra Bihorac, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Immediately before and after each intervention up to 7 days |
| Amount of sedatives requested by subjects | Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0. | Entire ICU stay up to 7 days |
| Amount of sedatives subjects receive | Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0. | Entire ICU stay up to 7 days |
| Subject's quality of sleep | Richards-Campbell Sleep Questionnaire (RCSQ) five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality. | Daily up to 14 days |
| DREAMS usability and acceptability questionnaire | A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree. | After each intervention up to 14 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |