Digital Guided Meditation and Relaxation for Delirium

(DREAMS Trial)

Overseen By Brooke Armfield, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Intubated, Neuro-vascular event, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 7 days

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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). ^{3 8 9 10 11}

Research Team

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.

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

Group I: Mediation and Relaxation Intervention Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Melatonin and its analog ramelteon have shown effectiveness in preventing delirium, as demonstrated in three controlled studies, suggesting their potential as therapeutic options.

Delirium is linked to disruptions in brain activity and circadian rhythms, indicating that melatonergic drugs may help restore normal brain function and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium and its prevention with melatonergic drugs. Howland, RH.[2014]

The primary treatment for delirium focuses on non-pharmacological interventions, such as early mobilization and cognitive reorientation, which are essential for improving patient outcomes.

While specific medications for delirium are limited, the choice of sedatives can significantly affect the incidence of delirium, highlighting the importance of careful medication management in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-pharmacological and pharmacological therapy of delirium]. Reith, S.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Delirium on the ICU: clinical impact, diagnostic workup, and therapy]. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A randomized, clinical trial investigating the use of a digital intervention to reduce delirium-associated agitation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Delirium in the elderly. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Software-guided (PREVEDEL) cognitive stimulation to prevent delirium in hospitalised older adults: study protocol. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The importance of diagnosing and managing ICU delirium. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Positive Stimulation for Medically Sedated Patients: A Music Therapy Intervention to Treat Sedation-Related Delirium in Critical Care. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Delirium and its prevention with melatonergic drugs. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Rest-activity patterns in patients with delirium. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Delirium: a disturbance of circadian integrity? [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Non-pharmacological and pharmacological therapy of delirium]. [2020]