Effect of Walking to the Operating Room on Preoperative Anxiety in Patients Scheduled for Outpatient Laser Therapy for Venous Insufficiency: A Monocentric Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Level of anxiety
研究概览
简要总结
The operating room environment can be a source of anxiety for the patient, including in the context of outpatient surgery for which anxiolytic medication is rarely used. This anxiety-induced effect can be reinforced by the patient's lack of active participation.
Some studies have already shown the feasibility of patient walking to the operating room (OR) and advantages this approach(Kojima and Ina 2002; Lack 2016; Nagraj et al. 2006).
Moreover, recovery room complications and pain have also been shown to be greater after varicose vein surgery in patients with significant preoperative anxiety (Scavee et al. 2016).
Therefore, the investigators decided to test the effects of walking to OR for patients admitted for outpatient surgery for varicose vein surgery.
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
- •Outpatient minimal invasive laser therapy for venous insufficiency
排除标准
- •Inpatient surgery
- •Invasive surgery
- •Need for premedication
- •Use of walking aid
- •Non-French speaking patient
- •Patient refusal
研究组 & 干预措施
Walk group
Patients walked to operating room (OR)
干预措施: Walking to OR (Behavioral)
Bed group
Patients go to OR while in bed
结局指标
主要结局
Level of anxiety
时间窗: Before departure of the outpatient unit
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Level of anxiety
时间窗: Preoperatively in the room
French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)
Level of anxiety
时间窗: Preoperatively in front of OR
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
次要结局
- Level of pain(At Day 1)
- Presence of nausea and vomiting(at Day 1)
- Level of pain(Within 1 hour after admission in the Post Anesthesia Care Unit after surgery)
- Level of pain(Before departure of outpatient unit)
- Presence of nausea and vomiting(During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h)
- Presence of nausea and vomiting(During the stay in the outpatient unit after surgery assessed up to 12h)
研究者
Claude Hallet
Principal investigator
University of Liege