Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence to Protocol Rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures.
干预措施: 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.
干预措施: Routine post-operative management and standard delirium reduction measures. (Procedure)
结局指标
主要结局
Adherence to Protocol Rate
时间窗: Day 30 post surgery
Recruitment Rate
时间窗: Day 0
Time Spent with Device
时间窗: Day 7 post surgery or discharge, whichever comes first
Patient Satisfaction and Perceived Benefits
时间窗: 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.
次要结局
- 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)
研究者
Alana Flexman
Clinical Associate Professor
University of British Columbia