Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery

NCT ID: NCT07051096

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-01-31

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.

Detailed Description

Hypotheses:

This study will explore: (1) the feasibility of using Mindful Garden-a novel, nature-based digital therapeutic device offering responsive imagery and sound with biofeedback-in patients undergoing cardiac surgery; and (2) whether its use reduces psychotropic medication use, agitation, anxiety, and both the incidence and duration of postoperative delirium.

Rationale:

Delirium is a frequent, serious complication after cardiac surgery, leading to prolonged hospital stays, increased costs, and higher mortality rates. Although medications are often used to manage delirium-related behavior, they can lead to over-sedation and do not reliably prevent or treat delirium. There is an urgent need for safe, effective, non-pharmacological interventions in high-risk groups. Mindful Garden offers a screen-based display of dynamic nature scenes with interactive elements that respond to physiological cues. In prior ICU settings, brief exposure to Mindful Garden reduced agitation and the need for unscheduled medications. However, its effectiveness in preventing or managing delirium specifically in cardiac surgical patients remains unexplored.

Objectives:

The primary goals are to evaluate the feasibility of implementing Mindful Garden (in terms of recruitment, adherence, data completeness), its usage patterns, and patient satisfaction. Secondary aims include assessing the device's impact on delirium incidence and severity, need for psychotropic medications, agitation levels, anxiety, postoperative recovery, and length of hospital stay.

Participants:

This pilot randomized controlled trial will enroll 60 adult patients (aged ≥18 years) undergoing open-heart surgery at St. Paul's Hospital in Vancouver, Canada. Each arm will include 30 patients. Participants must have at least one risk factor for delirium, including being aged 64 or older, a history of delirium, stroke or TIA, cognitive impairment, or depression. Individuals with severe pre-existing cognitive impairments will be excluded.

Intervention:

Participants will be randomized 1:1 to either the Mindful Garden intervention or standard care. Due to the nature of the intervention, blinding is not feasible. In the intervention group, the Mindful Garden device will be made available for up to 7 days postoperatively or until discharge. All participants will receive standard post-operative care, including routine non-drug delirium prevention measures.

Outcomes:

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

• Frequency of unscheduled psychotropic medication use
• Incidence and severity of delirium (measured via the Intensive Care Delirium Screening Checklist and Confusion Assessment Method)
• Agitation (Richmond Agitation Sedation Scale)
• Anxiety (State Trait Anxiety Inventory)
• Recovery quality (QoR-15 score)
• Presence of Hallucinations (PSYRATS)
• Hospital length of stay

Anticipated Impact:

This pilot trial will assess whether integrating the Mindful Garden device into post-cardiac surgery care is practical and beneficial. Results will inform a larger trial and may support broader implementation of non-pharmacological digital therapeutics to enhance recovery, reduce delirium, and minimize reliance on psychoactive drugs in surgical settings.

Conditions

Delirium - Postoperative; Agitation; Anxiety; Cardiac Surgery Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

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.

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Routine post-operative management and standard delirium reduction measures.

Intervention Type: PROCEDURE

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

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.

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.

Intervention Type: DEVICE

Routine post-operative management and standard delirium reduction measures.

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

Intervention Type: PROCEDURE

Other Intervention Names

MindfulGarden

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Anesthesiologists' Society

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Alana Flexman

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alana Flexman, MD MBA

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Alana Flexman, MD

Role: CONTACT

aflexman@providencehealth.bc.ca

604-682-2344 ext. 62115

Facility Contacts

Alana Flexman, MD

Role: primary

aflexman@providencehealth.bc.ca

604-682-2344 ext. 62115

References

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.

Reference Type: BACKGROUND

PMID: 37903857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26395395 (View on PubMed)

Other Identifiers

H24-03693

Identifier Type: -

Identifier Source: org_study_id