MindfulGarden for Delirium

(RESPITE Trial)

Overseen By Alana Flexman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Severe cognitive impairment, Visual impairment, Psychiatric disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called MindfulGarden to determine its effectiveness in aiding patients after heart surgery. The device displays calming nature images to potentially reduce the need for certain medications and improve recovery for those at risk of confusion or disorientation (delirium). Participants will be divided into two groups: one using MindfulGarden and the other receiving standard care. Ideal candidates for this trial are individuals planning to undergo open-heart surgery with a history of conditions such as stroke or cognitive issues. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancing patient care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems like you can continue your usual medications, but it's best to confirm with the trial coordinators.

What prior data suggests that the MindfulGarden device is safe for patients undergoing cardiac surgery?

Research has shown that MindfulGarden, a new device displaying calming nature images, has been tested on patients after surgery. One study found it reduced the need for extra medications for delirium, a common post-surgery state of confusion. This suggests the device is gentle on patients. No reports have directly linked negative side effects to using MindfulGarden. As it is not a drug, it likely poses fewer risks than medications. Overall, existing evidence indicates that MindfulGarden is safe for patients recovering from heart surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MindfulGarden intervention because it offers an innovative approach to managing delirium through a non-pharmacological method. Unlike standard treatments for delirium in post-operative cardiac surgery patients, which often rely on medications like antipsychotics and sedatives, MindfulGarden uses immersive digital technology to create a calming environment. This method aims to reduce stress and confusion by engaging patients with soothing visuals and sounds. By potentially minimizing the need for medication, MindfulGarden could decrease side effects and improve recovery experiences.

What evidence suggests that the MindfulGarden device is effective for reducing delirium in cardiac surgery patients?

Research has shown that the MindfulGarden device, which participants in this trial may receive, can help reduce the need for extra medications for confusion and restlessness. In one study, patients who used MindfulGarden needed fewer medications for these issues. The device uses soothing visuals that may ease confusion after surgery. Early findings suggest it could also improve overall recovery for patients. While more research is needed, these initial results are promising for those undergoing heart surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Alana Flexman, MD MBA

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for patients undergoing cardiac surgery who may experience postoperative issues like delirium or agitation. Participants will receive standard care, but some will also use a new device called MindfulGarden that shows responsive nature imagery.

Inclusion Criteria

I am scheduled for open-heart surgery, such as bypass or valve replacement.

I am under 65 or have a history of delirium, stroke/TIA, cognitive issues, or medicated depression.

Able to understand study procedures and provide informed consent in English

Exclusion Criteria

I have vision problems that glasses or contacts can't fix.

Severe pre-existing cognitive impairment (Montreal Cognitive Assessment [MOCA6]<10)

Significant impairment from psychiatric disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine post-operative management and are randomized to either receive the MindfulGarden device or standard care

7 days

Daily monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of delirium, anxiety, and recovery quality

30 days

Day 0, 3, 30 post surgery

What Are the Treatments Tested in This Trial?

Interventions

• MindfulGarden

Trial Overview

The study tests if the MindfulGarden device can help reduce delirium and improve recovery by providing calming, responsive visuals after surgery. Patients are randomly chosen to either use this device or not alongside regular post-op care.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures.

Group II: Control Group Active Control 1 Intervention

Participants will receive standard care, which includes routine post-operative care pathways for cardiac surgery, and standard delirium reduction measures.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Anesthesiologists' Society

Collaborator

Trials

19

Recruited

3,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07051096

Responsive Nature-Driven Imagery to Reduce Delirium ...

The goal of this clinical trial is to learn if a novel device (MindfulGarden) is beneficial in a population of patients undergoing cardiac surgery.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10616287/

A randomized, clinical trial investigating the use of a digital ...

Exposure to MindfulGarden significantly reduced the proportion of patients who received unscheduled medications for delirium and agitation ...

3.

withpower.com

withpower.com/trial/phase-emergence-delirium-8-2025-acd76

MindfulGarden for Delirium · Info for Participants

Trial Overview The study tests if the MindfulGarden device can help reduce delirium and improve recovery by providing calming, responsive visuals after surgery.

4.

ctv.veeva.com

ctv.veeva.com/study/responsive-nature-driven-imagery-to-reduce-delirium-after-cardiac-surgery

Responsive Nature-Driven Imagery to Reduce Delirium After ...

Outcomes: Primary feasibility outcomes include recruitment success, adherence to study protocol, and participant satisfaction. Secondary clinical outcomes ...

5.

journals.healio.com

journals.healio.com/doi/10.3928/00989134-20211012-03

Pilot Study of a Digital Screen–Based Calming Device for ...

The current small-scale pilot study demonstrated some positive effects of a screen-based calming device in de-escalating BPSD in PwD and decreasing care time.

6.

mdpi.com

mdpi.com/2308-3417/8/1/11

Occurrence of Postoperative Delirium and the Use ...

(1) Background: Postoperative delirium (POD) poses a high risk of worsening outcomes for patients and is also a burden for hospitals.