Digital Rehabilitation Environment Augmenting Medical System

Not Applicable

Active, not recruiting

• Conditions: Delirium
• Interventions: Device: Technology based guided meditation and relaxation

• Registration Number: NCT03385993
• Lead Sponsor: University of Florida

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-29
• Study Start: 2018-01-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mediation and Relaxation Intervention	Technology based guided meditation and relaxation	Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.

Primary Outcome Measures

Name	Time	Method
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)
Heart Rate	Immediately before and after each intervention up to 7 days	Alterations to vital signs allow for Non-Verbal Pain assessments
Blood Pressure -Systolic	Immediately before and after each intervention up to 7 days	Alterations to vital signs allow for Non-Verbal Pain assessments

Secondary Outcome Measures

Name	Time	Method
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)
Respiratory Rate	Entire ICU stay up to 7 days	Alterations to vital signs allow for Non-Verbal Pain assessments
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.
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.
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.
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.

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States