Digital Rehabilitation Environment Augmenting Medical System (DREAMS)

University of Florida

Status: Active, not recruiting

Conditions: Delirium

Treatments: Device: Technology based guided meditation and relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT03385993

IRB201703107

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Mediation and Relaxation Intervention

Experimental group

Description:

Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.

Treatment:

Device: Technology based guided meditation and relaxation