100 Participants Needed

Digital Guided Meditation and Relaxation for Delirium

(DREAMS Trial)

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Overseen ByBrooke Armfield, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial will test a digital system called D.R.E.A.M.S. that creates a calming environment for ICU patients. It aims to reduce stress by managing noise and light. The goal is to prevent delirium, a common issue in critically ill patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Technology based guided meditation and relaxation for delirium?

A study showed that a digital intervention using nature-based dynamic content reduced agitation in delirious patients, suggesting that digital relaxation techniques can help manage delirium symptoms.12345

Is digital guided meditation and relaxation safe for humans?

Digital interventions like 'MindfulGarden', which use nature-based visuals to reduce agitation in delirious patients, have been studied and shown to be safe, with no reported adverse effects during the trial.12567

How does digital guided meditation and relaxation differ from other treatments for delirium?

Digital guided meditation and relaxation is unique because it uses technology to help patients relax and meditate, which may help regulate their sleep-wake cycles and reduce symptoms of delirium. Unlike traditional drug treatments, this approach focuses on non-pharmacological methods to improve mental well-being and circadian rhythms (the body's natural daily cycles).3891011

Research Team

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Azra Bihorac, MD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I am under 18 years old.
I am currently intubated and unable to speak.
I cannot use or wear the DREAMS equipment.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a technology-based guided meditation and relaxation exercise using a tablet or virtual reality headset

Up to 7 days
Daily interventions

Follow-up

Participants are monitored for cognitive, behavioral, and emotional outcomes, including anxiety, sleep quality, and sedation levels

Up to 14 days
Daily assessments

Treatment Details

Interventions

  • Technology based guided meditation and relaxation
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Findings from Research

Delirium is a serious condition affecting 10-92% of hospitalized patients, leading to long-term cognitive deficits, increased dependence, and higher mortality rates, making its prevention crucial.
Effective management of delirium involves daily structured screening and addressing modifiable risk factors, with potential treatment options including behavioral interventions and possibly medications like anti-inflammatory and antipsychotic drugs.
[Delirium on the ICU: clinical impact, diagnostic workup, and therapy].Theuerkauf, N., Guenther, U.[2021]
The Positive Stimulation for Medically Sedated Patients (PSMSP) protocol, which includes personalized music and family storytelling, may help reduce agitation and improve arousal in ICU patients recovering from sedation, potentially mitigating sedation-related delirium.
This nonpharmacologic approach offers a structured intervention that could be safer than pharmacologic treatments, which often lead to oversedation and adverse effects, highlighting the need for critical care teams to incorporate such therapies into patient care.
Positive Stimulation for Medically Sedated Patients: A Music Therapy Intervention to Treat Sedation-Related Delirium in Critical Care.Head, J., Gray, V., Masud, F., et al.[2022]
This study is a randomized controlled trial involving 104 patients in intensive care, aiming to assess the feasibility and effectiveness of a multimodal intervention (relaxation, guided imagery, and massage) to prevent delirium, a common complication in critically ill patients.
The primary outcome is the incidence of delirium, with secondary outcomes including pain, inflammation, heart rate variability, stress, and quality of life, which will help determine if this integrative approach can improve patient outcomes in the ICU.
Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients' delirium and related outcomes.Papathanassoglou, EDE., Skrobik, Y., Hegadoren, K., et al.[2020]

References

[Delirium on the ICU: clinical impact, diagnostic workup, and therapy]. [2021]
A randomized, clinical trial investigating the use of a digital intervention to reduce delirium-associated agitation. [2023]
Delirium in the elderly. [2019]
Software-guided (PREVEDEL) cognitive stimulation to prevent delirium in hospitalised older adults: study protocol. [2023]
The importance of diagnosing and managing ICU delirium. [2022]
Positive Stimulation for Medically Sedated Patients: A Music Therapy Intervention to Treat Sedation-Related Delirium in Critical Care. [2022]
Relaxation for Critically ill Patient Outcomes and Stress-coping Enhancement (REPOSE): a protocol for a pilot randomised trial of an integrative intervention to improve critically ill patients' delirium and related outcomes. [2020]
Delirium and its prevention with melatonergic drugs. [2014]
Rest-activity patterns in patients with delirium. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
Delirium: a disturbance of circadian integrity? [2022]
[Non-pharmacological and pharmacological therapy of delirium]. [2020]
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