Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery

NCT07051096 | Not Yet Recruiting

• 1 other identifier: H24-03693
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a novel device (MindfulGarden) is beneficial in a population of patients undergoing cardiac surgery. The main questions it aims to answer are: Is a novel device (MindfulGarden) that uses responsive nature-driven imagery feasible in patients undergoing cardiac surgery? Will use of this device reduce the use of psychotropic medications, improve recovery experience, and improve delirium? Participants will receive routine post-operative management and standard delirium reduction measures. They will be randomized into two groups where one receives the novel device (MindfulGarden) and the other does not.

Conditions

Delirium - Postoperative; Agitation; Anxiety; Cardiac Surgery Recovery

Keywords

Randomized trial; Delirium; Cardiac surgery; MindfulGarden

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Day 0

• Adherence to Protocol Rate

  Day 30 post surgery

• Time Spent with Device

  Day 7 post surgery or discharge, whichever comes first

• Patient Satisfaction and Perceived Benefits

  Using a Likert Scale in a patient satisfaction questionnaire. The Likert Scale uses 1 as Strongly Disagree and 5 as Strongly Agree.

  Day 7 post surgery or discharge, whichever comes first

Secondary Outcomes (7)

• Incidence and Severity (days) of Delirium

  Twice daily until Day 7 post surgery or discharge, whichever comes first

• Number of Unscheduled Psychoactive Medications or IV Infusions

  Day 7 post surgery or discharge, whichever comes first

• Agitation in CSICU

  Every 4 hours while admitted to CSICU

• Patient reported outcomes of anxiety

  Day 0, 3, 30 post surgery

• Length of CSICU and hospital stays (days)

  Day 30 or day of discharge, whichever comes first

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: A novel device developed providing nature-driven responsive imagery that responds to the patient's physiological to distract, engage, and de-escalate behaviours of delirium.

Control Group

ACTIVE COMPARATOR

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

Procedure: Routine post-operative management and standard delirium reduction measures.

Interventions

A novel device developed providing nature-driven responsive imagery that responds to the patient's physiological to distract, engage, and de-escalate behaviours of delirium. DEVICE

This device will be provided on top of routine post-operative management and standard delirium reduction measures. It has proven effective in a previous clinical trial by reducing agitation and unscheduled medications. It displays nature-driven responsive imagery through an available mobile screen/device for the first 7 days after surgery or discharge, whichever comes first. The imagery adapts in real-time to the participant's movement and sound. The device will be placed at the foot of the bed while the patient is awake and may be interrupted at the discretion of the patient, bedside RN or attending physician.

Also known as: MindfulGarden

Intervention Group

Routine post-operative management and standard delirium reduction measures. PROCEDURE

Examples of routine post-operative care are sleep optimization, avoidance of delirium-promoting medications, orientation, and mobilization.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned open-heart cardiac surgery (e.g. coronary artery bypass grafting, valve replacement surgery);
• Able to understand study procedures and provide informed consent in English;
• At least one delirium risk factor: 1) Age less than 65yrs; 2) History of delirium; 3) History of stroke/TIA; 4) Known cognitive impairment; 5) Depression requiring medication.

You may not qualify if:

• Severe pre-existing cognitive impairment (Montreal Cognitive Assessment \[MOCA6\]\<10)
• Uncorrected visual impairment;
• Significant impairment from psychiatric disease;
• Enrolment in another clinical trial which may interfere with the study outcome measures.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (2)

• Nicholas M, Wittmann J, Norena M, Ornowska M, Reynolds S. A randomized, clinical trial investigating the use of a digital intervention to reduce delirium-associated agitation. NPJ Digit Med. 2023 Oct 30;6(1):202. doi: 10.1038/s41746-023-00950-4.

  PMID: 37903857 BACKGROUND

• Tse L, Schwarz SK, Bowering JB, Moore RL, Barr AM. Incidence of and Risk Factors for Delirium After Cardiac Surgery at a Quaternary Care Center: A Retrospective Cohort Study. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1472-9. doi: 10.1053/j.jvca.2015.06.018. Epub 2015 Jun 12.

  PMID: 26395395 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Psychomotor Agitation; Anxiety Disorders; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Alana Flexman, MD MBA

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alana Flexman, MD

CONTACT

604-682-2344; aflexman@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Patients will be randomized 1:1 to either the intervention (MindfulGarden) or standard of care. Due to the nature of the intervention, blinding is not possible. In the intervention group, MindfulGarden will be available to participants for the first 7 days after surgery or until discharge, whichever comes first. In both groups, participants will receive standard post-surgical care and routine non-pharmacological delirium reduction measures.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)