Delirium
Conditions
Keywords
Delirium Prevention, Virtual Reality, VR
Brief summary
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.
Detailed description
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).
Interventions
DEVICETechnology based guided meditation and relaxation
Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.
Exclusion criteria
The study team will exclude patients if: * Their anticipated ICU stay is less than one day * Patient is intubated and cannot communicate. * Age: \< 18 years * Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason * Baseline cognitive impairment (e.g., advanced dementia) * Patients who are unable to wear or use the DREAMS equipment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire | Immediately before and after each intervention Up to 7 days | 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) |
| Blood Pressure -Systolic | Immediately before and after each intervention up to 7 days | Alterations to vital signs allow for Non-Verbal Pain assessments |
| Heart Rate | Immediately before and after each intervention up to 7 days | Alterations to vital signs allow for Non-Verbal Pain assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | Entire ICU stay up to 7 days | Alterations to vital signs allow for Non-Verbal Pain assessments |
| Patient pain perception | Immediately before and after each intervention up to 7 days | Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters) |
| Amount of sedatives requested by subjects | Entire ICU stay up to 7 days | 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. |
| Amount of sedatives subjects receive | Entire ICU stay up to 7 days | 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. |
| Subject's quality of sleep | Daily up to 14 days | 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. |
| DREAMS usability and acceptability questionnaire | After each intervention up to 14 days | A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAzra Bihorac, MD
University of Florida
Outcome results
None listed