DeliriumDREAMSNCT03385993
Digital Rehabilitation Environment Augmenting Medical System
A study testing Technology based guided meditation and relaxation in people with Delirium, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Technology based guided meditation and relaxation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Delirium
- Being tested
- Technology based guided meditation and relaxation
- Keywords
- Delirium Prevention, Virtual Reality, VR
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology based guided meditation and relaxationDevice
Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Technology based guided meditation and relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately before and after each intervention Up to 7 days
Blood Pressure -Systolic
Alterations to vital signs allow for Non-Verbal Pain assessments
Measured: Immediately before and after each intervention up to 7 days
Heart Rate
Alterations to vital signs allow for Non-Verbal Pain assessments
Measured: Immediately before and after each intervention up to 7 days
Secondary outcomes (6)
Respiratory Rate
Alterations to vital signs allow for Non-Verbal Pain assessments
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After each intervention up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start16 Jan 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385993
- Sponsor's protocol ID
- IRB201703107
- Acronym
- DREAMS
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2017
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Rehabilitation Environment Augmenting Medical System
- ClinicalTrials.gov ID
- NCT03385993
- Acronym / sponsor ID
- DREAMS / IRB201703107
- Conditions
- Delirium
- Keywords
- Delirium Prevention, Virtual Reality, VR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediation and Relaxation Intervention | Experimental | Device: Technology based guided meditation and relaxationPatients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology based guided meditation and relaxationSubjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day. | Device | Mediation and Relaxation Intervention |
Primary outcome
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
6 secondary outcomes
Respiratory Rate
Time frame: Entire ICU stay up to 7 days
Patient pain perception
Time frame: Immediately before and after each intervention up to 7 days
Amount of sedatives requested by subjects
Time frame: Entire ICU stay up to 7 days
Amount of sedatives subjects receive
Time frame: Entire ICU stay up to 7 days
Subject's quality of sleep
Time frame: Daily up to 14 days
DREAMS usability and acceptability questionnaire
Time frame: After each intervention up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology based guided meditation and relaxation in people with Delirium, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.