Effect of the Built Operating Room Environment on Patient Outcome
研究概览
详细说明
Problem: Anxiety prior to surgery is an expected emotion. Research has been conducted on methods to reduce anxiety prior to entering the operating room (OR). These studies have involved some form of distraction, almost all finding that some form of distraction prior to entering the OR decreases both physiologic signs and patient reports of anxiety. Very few of these studies have carried the intervention into the OR itself. Steris Corporation has developed an automated surgical suite environmental system, called SignatureSuite™, that controls the level of lighting, images on OR monitors, and ambient background audio via preset, computerized automation for use before and after anesthesia. The research question is: What is the effect of the SignatureSuite OR environment on patient anxiety and analgesic use? Study methods: The proposed study will be a two arm randomized controlled trial. Randomization will occur at the surgeon level, based on SignatureSuite operating room environment (experimental group) versus a standard Marymount Hospital operating room environment (control group).
Data collection: The study will take place in the perioperative department of Cleveland Clinic's Marymount Hospital. Patient anxiety will be measured before and after surgery using an anxiety visual analog scale (VAS). Data about patient characteristics will be retrieved retrospectively by chart review. The effect of SignatureSuite on OR time will also be determined.
Sample characteristics: The patient sample will comprise patients undergoing thyroid and/or parathyroid surgery at Cleveland Clinic Marymount Hospital.
Sample size: 40 subjects per group will provide adequate power to detect large effect sizes (0.80) and is feasible in a reasonable period of time.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Garfield Heights、Ohio、美国、44125
- Cleveland Clinic Marymount Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- able to read and understand English;
- presentation for thyroid and/or parathyroid surgery at Marymount Hospital;
- visual capacity to complete the VAS
Exclusion Criteria:
- history of documented anxiety/depression disorder
- currently taking medications for depression/anxiety
- currently taking anticonvulsant medication and/or gamma-Aminobutyric acid analogs
- unable to read and understand English
- dementia
- vision loss making it impossible to complete the anxiety visual analog scale
- currently taking beta-blockers
- surgeon refusal for patient participation
- intra-operative emergency, such as cardiac incident requiring resuscitation or stabilizing medications, unplanned extubation, or early emergence from anesthesia
- other patient-related reasons that would affect eligibility to participate.
学习计划
研究是如何设计的?
设计细节
- 主要用途: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 |
|---|---|
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实验性的:SignatureSuite OR
The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.
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SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.
其他名称:
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无干预:Standard OR
Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.
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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 |
|---|---|---|
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Change (Difference) in Anxiety
大体时间:Pre-operatively to post-operatively
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Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety.
It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine."
Participants make a mark across the line to represent their current state of anxiety.
A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100.
Higher number means more anxiety.
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Pre-operatively to post-operatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
大体时间:Pre-operative to post-operative
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Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
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Pre-operative to post-operative
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Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
大体时间:Pre-operative to post-operative
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Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
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Pre-operative to post-operative
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Analgesic Use
大体时间:Postoperatively
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Number of people requiring analgesia in the post-anesthesia care unit
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Postoperatively
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合作者和调查者
调查人员
- 首席研究员:Christian N Burchill, PhD、The Cleveland Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
其他研究编号
- CCF15-009
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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