Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies (EASY-HD)
Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study
The goal of this prospective pilot study is to learn if the use of virtual reality and/or relaxing soundscapes can help lower anxiety in adult patients undergoing a scheduled coronary angiography or angioplasty as compared to the standard of care. The main questions it aims to answer are:
- The use of non-pharmacological strategies reduces intraprocedural stress and anxiety compared to standard of care
- Reducing anxiety limits the use of pharmacological agents, which increases patient safety.
Researchers will compare the use of relaxing soundscapes or virtual reality to the standard of care to see the effects of these strategies on pain, anxiety and stress.
Participants will:
- listen to relaxing soundscapes, OR experience virtual reality including soundscapes OR standard of care during their procedure,
- Answer pain, anxiety and recovery questionnaires,
- Answer satisfaction questionnaires.
研究概览
地位
详细说明
The EASY-HD project is a prospective, randomized, controlled pilot study to evaluate the effectiveness of immersive nonpharmacological strategies, soundscapes, and virtual reality (VR) on the reduction of intraprocedural anxiety and stress in patients undergoing a scheduled hemodynamic intervention (coronary angiography and/or angioplasty).
Adult patients will be included and randomized into three parallel groups (1:1:1): standard of care alone (control group), standard of care combined with relaxing soundscapes via headphones, or standard of care combined with virtual reality immersion in a soothing environment including sound. The devices will be set up 5 to 10 minutes before the procedure and continued througout.
This minimal-risk study aims to determine the feasibility and potential clinical benefit of these simple, reproducible non-pharmacological approaches to improve patient comfort and possibly reduce the need for hemodynamic sedation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Michele Jadin
- 电话号码：4186568711
- 邮箱：michele.jadin@criucpq.ulaval.ca
学习地点
-
-
Quebec
-
Québec、Quebec、加拿大、G1V 4G5
- IUCPQ
-
首席研究员：
- Olivier F Bertrand, MD, PhD
-
接触：
- Michele Jadin
- 电话号码：418-656-8711
- 邮箱：michele.jadin@criucpq.ulaval.ca
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults, 18 years or older
- Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
- Patient willing and able to understand the study
- Signed informed consent
Exclusion Criteria:
- Scheduled complex procedure (CTO, structural)
- Severe cognitive or psychiatric disorders
- Major hearing/visual impairment
- Severe motion sickness or history of malaise with Virtual Reality (VR)
- Complaints of nausea or vomiting
- History of epilepsy
- Claustrophobia
- Facial injuries
- In clinical isolation (infection control)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
Standard of care analgesic and anxiolytic therapy
|
|
|
实验性的：Auditive experience
A pre-defined non-invasive audio experience using relaxing soundscapes via headphones will be used along standard of care pain and anxiety-relief medication (on patient's demand).
|
Auditive distraction therapy
|
|
实验性的：Immersion experience
A pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand).
|
Virtual reality-lead audiovisual experience
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in patient-reported anxiety
大体时间：Baseline (preprocedural), periprocedural and at one-week follow-up
|
Change from baseline in patient reported anxiety evaluated by anxiety questionnaires Visual Analog Score for anxiety (0 = Not anxious at all - 10 = Extremely anxious) |
Baseline (preprocedural), periprocedural and at one-week follow-up
|
|
Change in patient-reported anxiety
大体时间：Baseline, Periprocedural, and at one-week follow-up
|
Change from baseline in patient reported anxiety evaluated by anxiety questionnaires State-Trait Anxiety Invetory for Adults - 6 item short form |
Baseline, Periprocedural, and at one-week follow-up
|
|
Change in patient-reported pain
大体时间：Baseline, periprocedural and at one-week follow-up
|
Change from baseline in patient reported pain evaluated by pain questionnaires Visual Analog Scale for pain (0=No pain - 10 = Worst pain possible) |
Baseline, periprocedural and at one-week follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Use of analgesic and anxiolytic medications
大体时间：Within 48 hours before and after the procedure
|
Use vs no-use of analgesic (opioid/non-opioid) and/or anxiolytic medication. If analgesic and/or anxiolytic medication is used, its type, dose and frequency will be registered. |
Within 48 hours before and after the procedure
|
|
Change from baseline in physiological factors associated with pain and anxiety - Heart Rate
大体时间：Baseline, periprocedural
|
Heart rate (beats per minute)
|
Baseline, periprocedural
|
|
Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
大体时间：Baseline, periprocedural
|
Respiratory rate (breaths per minute)
|
Baseline, periprocedural
|
|
Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
大体时间：Baseline, Periprocedural
|
Blood pressure (mmHg)
|
Baseline, Periprocedural
|
|
Incidence of adverse events of interest
大体时间：Within 10 days of the procedure
|
Patient-reported nausea, dizziness and increased anxiety will be collected
|
Within 10 days of the procedure
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Incidence of adverse cardiac events
大体时间：Within 10 days of the procedure
|
Within 10 days of the procedure
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EASY-HD
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