Health TrialsbyHealthPanel

Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery

ConditionsDelirium - PostoperativeAgitationAnxietyCardiac Surgery Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

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

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Time frame
Day 0
2

Adherence to Protocol Rate

Time frame
Day 30 post surgery
3

Time Spent with Device

Time frame
Day 7 post surgery or discharge, whichever comes first
4

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.

Time frame
Day 7 post surgery or discharge, whichever comes first

Secondary outcomes

1

Incidence and Severity (days) of Delirium

Measured by the Intensive Care Delirium Screening Checklist in the CSICU and the Confusion Assessment Method after discharge to the ward.

Time frame
Twice daily until Day 7 post surgery or discharge, whichever comes first
2

Number of Unscheduled Psychoactive Medications or IV Infusions

Examples of medications are haloperidol, loxapine, and dexmedetomidine

Time frame
Day 7 post surgery or discharge, whichever comes first
3

Agitation in CSICU

Measured using the Richmond Agitation Sedation Scale: Positive scores (+1 to +4): Indicate increasing agitation or restlessness. Negative scores (-1 to -5): Indicate increasing levels of sedation or unconsciousness. A score of 0: represents the desired state of alertness and calmness

Time frame
Every 4 hours while admitted to CSICU
4

Patient reported outcomes of anxiety

Patient reported outcomes of anxiety will be measured using the State Trait Anxiety Inventory. The State Trait Anxiety Inventory consists of 40 items in total. 20 items for State Anxiety (S-Anxiety) range 20-80 and 20 items for Trait Anxiety (T-Anxiety) range 20-80.

Time frame
Day 0, 3, 30 post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Canadian Anesthesiologists' Society

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: