Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Adherence to Protocol Rate
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention Group
Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures.
Intervention: 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)
Control Group
Participants will receive standard care, which includes routine post-operative care pathways for cardiac surgery, and standard delirium reduction measures.
Intervention: Routine post-operative management and standard delirium reduction measures. (Procedure)
Outcomes
Primary Outcomes
Adherence to Protocol Rate
Time Frame: Day 30 post surgery
Recruitment Rate
Time Frame: Day 0
Time Spent with Device
Time Frame: Day 7 post surgery or discharge, whichever comes first
Patient Satisfaction and Perceived Benefits
Time Frame: Day 7 post surgery or discharge, whichever comes first
Using a Likert Scale in a patient satisfaction questionnaire. The Likert Scale uses 1 as Strongly Disagree and 5 as Strongly Agree.
Secondary Outcomes
- Number of Unscheduled Psychoactive Medications or IV Infusions(Day 7 post surgery or discharge, whichever comes first)
- Length of CSICU and hospital stays (days)(Day 30 or day of discharge, whichever comes first)
- Patient reported Quality of Recovery(Day 0, 3, 30 post surgery)
- Incidence and Severity (days) of Delirium(Twice daily until 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)
- Presence of hallucinations and delusions(Day 3 post surgery)
Investigators
Alana Flexman
Clinical Associate Professor
University of British Columbia