Digital Rehabilitation Environment Augmenting Medical System (DREAMS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium
• Intervention / Treatment: Device: Technology based guided meditation and relaxation

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Azra Bihorac, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; VR; Delirium Prevention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: IRB201703107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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