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Behavioural Intervention

Digital Guided Meditation and Relaxation for Delirium (DREAMS Trial)

N/A

Recruiting

Led By Azra Bihorac, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily up to 14 days

Awards & highlights

DREAMS Trial Summary

This trial will test whether an immersive digital reality system can help reduce the occurrence of delirium in ICU patients.

Who is the study for?

This trial is for adults over 18 years old at UF Health Shands Hospital who are not currently experiencing delirium. It's open to ICU patients unless they expect to stay less than a day, can't communicate due to intubation, have trouble using the tech equipment, severe cognitive issues like advanced dementia, or recent major brain events/surgery.Check my eligibility

What is being tested?

The D.R.E.A.M.S. study tests if a high-tech guided meditation and relaxation system can help prevent mental and emotional problems that often happen after critical illness or being in intense medical environments which could lead to delirium.See study design

What are the potential side effects?

Since this intervention involves technology-based meditation, side effects might be minimal but could include discomfort with wearing the equipment or possible stress from engaging with digital reality tools.

DREAMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older, admitted to UF Health Shands Hospital, and not confused.

DREAMS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire

Blood Pressure -Systolic

Heart Rate

Secondary outcome measures

Amount of sedatives requested by subjects

Amount of sedatives subjects receive

DREAMS usability and acceptability questionnaire

+3 more

DREAMS Trial Design

1Treatment groups

Experimental Treatment

Group I: Mediation and Relaxation InterventionExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,567 Total Patients Enrolled

4 Trials studying Delirium

591 Patients Enrolled for Delirium

Azra Bihorac, MDPrincipal InvestigatorUniversity of Florida

5 Previous Clinical Trials

699 Total Patients Enrolled

2 Trials studying Delirium

201 Patients Enrolled for Delirium

Media Library

Technology based guided meditation and relaxation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03385993 — N/A

Delirium Clinical Trial 2023: Technology based guided meditation and relaxation Highlights & Side Effects. Trial Name: NCT03385993 — N/A

Technology based guided meditation and relaxation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03385993 — N/A

Delirium Research Study Groups: Mediation and Relaxation Intervention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the central aims of this research endeavor?

"The primary metric of this study, assessed over an immediate before and after period with additional follow-up for up to 7 days, is Heart Rate. Secondary endpoints comprise of the amount of sedatives prescribed based on Richmond Agitation-Sedation Scale (RASS), patients' quality of sleep as reported in Richards-Campbell Sleep Questionnaire (RCSQ) and finally a Likert scale assessment measuring DREAM's usability and acceptability."

Answered by AI

Are there any available openings in this scientific experiment for participants?

"Clinicaltrials.gov confirms that this medical study is presently recruiting patients for enrollment, with the first post appearing on January 16th 2018 and the most recent update having occurred on October 20th 2022."

Answered by AI

How many participants have volunteered for this research trial?

"Affirmative. Clinicaltrials.gov documents that this medical experiment, which was published on January 16th 2018, is currently recruiting patients. The research requires approximately 100 volunteers from a single site to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Rehabilitation Environment Augmenting Medical System

2018. "Digital Rehabilitation Environment Augmenting Medical System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03385993.