Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Feasibility of Implementing Preoperative Guided Meditation
研究概览
简要总结
The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.
详细描述
This is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. Patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The proceduralists that will be performing the peripheral vascular interventions will be blinded to the group allocation.
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
- •18 years of age or older
- •Undergoing an endovascular procedure for peripheral vascular disease
- •Anesthesia plan for procedural sedation and analgesia
排除标准
- •Pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder
- •Non-English speaking
- •Prior history of ipsilateral lower extremity amputation
- •Urgent or Emergent Surgery
- •Anesthesia plan for general anesthesia
- •Undergoing a hybrid procedure (simultaneous endovascular and open surgery)
结局指标
主要结局
Feasibility of Implementing Preoperative Guided Meditation
时间窗: Immediately before surgery
Feasibility will be defined as \>80% of the patients enrolled in the intervention arm having successfully completed both rounds of perioperative meditation.
次要结局
- Anxiety - STAI-6(Postoperative (within 6 hours after surgery))
- Interoceptive Attention - MAIA (Noticing Sub Scale)(Postoperative (within 6 hours after surgery))
研究者
Anahita Dua, MBCHB, MBA, MSC
Associate Professor
Massachusetts General Hospital