Delirium - PostoperativeRESPITENCT07051096
Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery
A study testing 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. and Routine post-operative management and standard delirium reduction measures. in people with Delirium - Postoperative and Agitation, run by University of British Columbia at 1 site in Canada.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium - Postoperative, Agitation, Anxiety
- What is being tested?
- 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. and Routine post-operative management and standard delirium reduction measures.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Alana Flexman, MD, 604-682-2344 ext. 62115, aflexman@providencehealth.bc.ca
About this study
Official title: Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled 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.
Read the 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
- Being tested
- 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., Routine post-operative management and standard delirium reduction measures.
- Keywords
- Randomized trial, Delirium, Cardiac surgery, MindfulGarden
- Medical subject headings
- Emergence Delirium, Psychomotor Agitation, Anxiety Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called MindfulGarden
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 or surgery
Examples of routine post-operative care are sleep optimization, avoidance of delirium-promoting medications, orientation, and mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures. Receives: 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. Receives: Procedure: Routine post-operative management and standard delirium reduction measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Measured: Day 0
Adherence to Protocol Rate
Measured: Day 30 post surgery
Time Spent with Device
Measured: 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.
Measured: Day 7 post surgery or discharge, whichever comes first
Secondary outcomes (7)
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.
Measured: Twice daily until Day 7 post surgery or discharge, whichever comes first
Number of Unscheduled Psychoactive Medications or IV Infusions
Examples of medications are haloperidol, loxapine, and dexmedetomidine
Measured: Day 7 post surgery or discharge, whichever comes first
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
Measured: Every 4 hours while admitted to CSICU
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.
Measured: Day 0, 3, 30 post surgery
Length of CSICU and hospital stays (days)
Measured: Day 30 or day of discharge, whichever comes first
Patient reported Quality of Recovery
Measured using Quality of Recovery (QoR-15). Patients score items on a 1 to 5 scale with 1 being Not at All and 5 being Extremely. These scores are totalled where 15-30 indicates Poor Quality of Recovery, 31-50 indicates Moderate Quality of Recovery, and 51-75 indicates Good Quality of Recovery.
Measured: Day 0, 3, 30 post surgery
Presence of hallucinations and delusions
Measured using the Psychotic Symptom Rating Scales (PSYRATS). PSYRATS has 2 subscales: Auditory Hallucinations (AH) and Delusions (D). AH has 11 items each scored 0-4 with a sum of 0 indicating no symptoms and a sum of 44 indicating most severe symptoms. D has 6 items each scored 0-4 with a sum of 0 indicating no symptoms and a sum of 24 indicating most severe symptoms.
Measured: Day 3 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Responsible party
- Principal investigator, Alana Flexman, University of British Columbia
- Investigators
- Alana Flexman, MD MBA, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051096
- Sponsor's protocol ID
- H24-03693
- Acronym
- RESPITE
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality restrictions from institution.
Publications
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.
PubMed 37903857Tse 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.
PubMed 26395395
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07051096
- Acronym / sponsor ID
- RESPITE / H24-03693
- Conditions
- Delirium - Postoperative, Agitation, Anxiety, Cardiac Surgery Recovery
- Keywords
- Randomized trial, Delirium, Cardiac surgery, MindfulGarden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | 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.Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures. |
| Control Group | Active comparator | Procedure: Routine post-operative management and standard delirium reduction measures.Participants will receive standard care, which includes routine post-operative care pathways for cardiac surgery, and standard delirium reduction measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.Also: MindfulGardenThis 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. | Device | Intervention Group |
| 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. | Procedure or surgery | Control Group |
Primary outcome
Recruitment Rate
Time frame: Day 0
Adherence to Protocol Rate
Time frame: Day 30 post surgery
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.
7 secondary outcomes
Incidence and Severity (days) of Delirium
Time frame: Twice daily until Day 7 post surgery or discharge, whichever comes first
Number of Unscheduled Psychoactive Medications or IV Infusions
Time frame: Day 7 post surgery or discharge, whichever comes first
Agitation in CSICU
Time frame: Every 4 hours while admitted to CSICU
Patient reported outcomes of anxiety
Time frame: Day 0, 3, 30 post surgery
Length of CSICU and hospital stays (days)
Time frame: Day 30 or day of discharge, whichever comes first
Patient reported Quality of Recovery
Time frame: Day 0, 3, 30 post surgery
Presence of hallucinations and delusions
Time frame: Day 3 post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 37903857Nicholas 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.
- Background: PubMed 26395395Tse 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.
- Individual participant dataSharing planned: No. Confidentiality restrictions from institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alana Flexman, MD MBA principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. and Routine post-operative management and standard delirium reduction measures. in people with Delirium - Postoperative and Agitation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alana Flexman, MD (604-682-2344 ext. 62115, aflexman@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.