Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
The purpose of this study is to assess the impact of immersive soundscape on patient pain, stress, anxiety, heart rate and blood pressure during an outpatient vascular surgery procedure.
详细描述
Adult (≥18-years-old) patients having outpatient vascular surgery procedures who elect to participate in the study will be randomized to Control/ Intervention. For Control Subjects: procedure will be performed in the procedure room with no immersive soundscape. For Intervention Subjects procedure will be performed in the procedure room with immersive soundscape.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- English-speaking adults
排除标准
- •Patients needing an English interpreter
- •Patients who lack the capacity to provide consent.
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Measured in millimeters of mercury (mmHg)
Change in Heart Rate
时间窗: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Number of beats per minute
Change in Self-Report Visual Analog Pain Score
时间窗: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Using a ruler, patients select a pain score from 0, "no pain" to 100 "intolerable pain", with a higher score indicating greater pain. The distance between "0/ no pain" and the mark indicates the pain level. The following cut points for quantifying pain using a VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Change in Self-Report Visual Analog Anxiety Score
时间窗: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Using a ruler, patients select an anxiety score from 0, "no anxiety" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.
Change in Self-Report Visual Analog Stress Score
时间窗: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Using a ruler, patients select an anxiety score from 0, "no stress" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.
次要结局
未报告次要终点
研究者
Ellen C. Meltzer
Principal Investigator
Mayo Clinic