Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in patient-reported anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adults, 18 years or older
- •Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
- •Patient willing and able to understand the study
- •Signed informed consent
排除标准
- •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)
结局指标
主要结局
Change in patient-reported anxiety
时间窗: 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)
Change in patient-reported anxiety
时间窗: 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
Change in patient-reported pain
时间窗: 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)
次要结局
- Use of analgesic and anxiolytic medications(Within 48 hours before and after the procedure)
- Change from baseline in physiological factors associated with pain and anxiety - Heart Rate(Baseline, periprocedural)
- Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate(Baseline, periprocedural)
- Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure(Baseline, Periprocedural)
- Incidence of adverse events of interest(Within 10 days of the procedure)
研究者
Olivier F. Bertrand
MD, PhD
Laval University