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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital guided meditation and relaxation system to determine its effectiveness in reducing delirium, a condition causing confusion and agitation, in patients with critical illnesses. Participants will use an app on a tablet or a virtual reality headset for calming exercises. The trial seeks patients staying at UF Health Shands Hospital who can use the equipment and do not currently show signs of confusion. As an unphased trial, this study provides patients the opportunity to explore innovative approaches to managing delirium.

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 prior data suggests that this technology-based guided meditation and relaxation is safe?

Research has shown that using technology for guided meditation and relaxation is generally safe. One study found that digital meditation with nature-themed content reduced restlessness in patients without causing harm. Another study on virtual reality meditation showed it improved sleep and lowered the risk of confusion, with no major safety issues reported.

These findings suggest that guided meditation using technology is well-tolerated and appears to be a safe option for managing symptoms like restlessness and sleep problems. Those considering joining a trial can note that this treatment has maintained a good safety record so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital guided meditation and relaxation treatment for delirium because it uses cutting-edge technology like tablets and virtual reality headsets to deliver therapy. Unlike traditional treatments that often rely on medications such as antipsychotics, this approach provides a non-invasive and drug-free alternative. By leveraging technology, the treatment can offer a more immersive and engaging experience, potentially enhancing relaxation and reducing delirium symptoms more effectively.

What evidence suggests that technology-based guided meditation and relaxation is effective for reducing delirium?

Research has shown that digital guided meditation and relaxation can calm patients with delirium. In this trial, participants will use a technology-based guided meditation and relaxation exercise via an application on a tablet or virtual reality headset. One study found that digital tools featuring nature scenes reduced agitation in these patients. Another clinical trial indicated that digital therapies decreased both agitation and delirium, and also lessened the need for extra medication. These findings suggest that technology-based meditation and relaxation could effectively manage delirium symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

Azra Bihorac, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-delirium-2018-65040

Digital Guided Meditation and Relaxation for Delirium · Info ... A study showed that a digital intervention using nature-based dynamic content reduced agitation in delirious patients, suggesting that digital relaxation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8430840/

Overview and Strategy Analysis of Technology-Based ... Multicomponent family-delivered intervention was not effective in reducing delirium incidence nor days of delirium. Zachary et al [59], Hospital elder life ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03385993

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

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538756/

Virtual reality for relaxation in intensive care unit patients Further studies should examine preliminary effectiveness outcomes such as anxiety, stress, relaxation and distraction. Using a mixed methods ...

5. nature.com nature.com/articles/s41746-023-00950-4

A randomized, clinical trial investigating the use of a digital ... We aimed to determine if using a screen-based digital therapeutic intervention can reduce agitation and delirium, as well as reliance on unscheduled medication ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321352/

Effects of Virtual Reality Meditation on Sleep and Delirium ... The purpose of this study was to evaluate the effectiveness of virtual reality meditation compared with standard care on sleep quality and delirium ...

7. researchgate.net researchgate.net/publication/390587364_Effects_of_Virtual_Reality_Meditation_on_Sleep_and_Delirium_in_ICU_Patients_A_Randomized_Controlled_Trial

Effects of Virtual Reality Meditation on Sleep and Delirium ... The purpose of this study was to evaluate the effectiveness of virtual reality meditation compared with standard care on sleep quality and delirium ...