Digital Rehabilitation Environment Augmenting Medical System (DREAMS)
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ClinicalTrials.gov Identifier: NCT03385993 |
Recruitment Status :
Recruiting
First Posted : December 29, 2017
Last Update Posted : April 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Delirium | Device: Technology based guided meditation and relaxation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Digital Rehabilitation Environment Augmenting Medical System |
Actual Study Start Date : | January 16, 2018 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Mediation and Relaxation Intervention
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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Device: Technology 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. |
- Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire [ Time Frame: 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 [ Time Frame: Immediately before and after each intervention up to 7 days ]Alterations to vital signs allow for Non-Verbal Pain assessments
- Heart Rate [ Time Frame: Immediately before and after each intervention up to 7 days ]Alterations to vital signs allow for Non-Verbal Pain assessments
- Respiratory Rate [ Time Frame: Entire ICU stay up to 7 days ]Alterations to vital signs allow for Non-Verbal Pain assessments
- Patient pain perception [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385993
Contact: Julie S Cupka, BS | 352-294-8776 | jcupka@ufl.edu | |
Contact: Haleh Hashemighouchani, MD | 352-294-8776 | Haleh.Hashemighouchani@medicine.ufl.edu |
United States, Florida | |
UF Health | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Julie S Cupka, BS 352-294-8776 jcupka@ufl.edu | |
Contact: Haleh Hashemighouchani, MD 352-294-8776 Haleh.Hashemighouchani@medicine.ufl.edu | |
Sub-Investigator: Tezcan Ozrazgat Baslanti, PhD | |
Principal Investigator: Azra Bihorac, MD | |
Principal Investigator: Marko Suvajdzic, PhD | |
Principal Investigator: Parisa Rashidi, PhD | |
Sub-Investigator: Triton Ong, MA |
Principal Investigator: | Azra Bihorac, MD | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT03385993 |
Other Study ID Numbers: |
IRB201703107 |
First Posted: | December 29, 2017 Key Record Dates |
Last Update Posted: | April 2, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Delirium Prevention Virtual Reality VR |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |