Noise in the Operating Room at Induction and Patient Satisfaction and Experience (NOISE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in Maximum Noise Levels Pre-/Post-Education
研究概览
简要总结
Noise in the operating room is common and often unavoidable, but there is mixed evidence of its impact. Previous research has suggested that excessive noise at the time when a patient is being 'put to sleep' may lead to care teams missing changes in monitors, having difficulties focusing or increasing stress. However, it is unknown ifs noise at this time affects the patient's satisfaction with the overall surgical experience. The investigators are conducting a survey study to evaluate patients' and anesthesiologists' overall satisfaction at the time of induction, before and after an education program promoting reducing noise in the Operating Room.
Study Purpose: The purpose of this study is to investigate how noise levels that the time of induction in the OR (operating room) effect patient and anesthesiologists' satisfaction with the overall surgical experience.
Hypothesis: The null hypothesis is that there is no improvement in patient satisfaction with the reduction of noise at the time of induction.
Study Population: The Investigators will be including two study populations: patients age 19 or older undergoing elective, non-cardiac surgery with general anesthesia as the primary mode of anesthesia, and; Anesthesiologists working in these rooms.
Research Method: This will be a pre/post survey study of patients and Anesthesiologists perspectives of noise in the OR. The investigators will survey participants before and after an educational intervention for OR staff.
详细描述
1.0 BACKGROUND: Noise in the operating room (OR) is common whether it be related to surgical equipment, anesthetic monitors, or conversations between health care providers and patients regarding the procedure or patient status. In particular, certain periods can be louder than others, such as during induction and emergence of anesthesia, with preparation and conversations as the major sources of noise during induction. Noise at this time has been shown to lead to deleterious patient outcomes, as staff are unable to hear subtle or even significant changes in monitors, or have difficulty focusing during a critical time of induction. It has also been demonstrated that poor postoperative outcomes in pediatric patients and increase in stress levels in surgeons. While anecdotal, what is not elucidated in the literature is whether or not excess noise during induction affects a patient's perioperative satisfaction. Induction is often a distressing time for patients and extraneous noise may have a significant impact on their overall experience. This study is the first to explore the impact of noise at induction on patient satisfaction investigate whether a reduction in noise on induction can improve patient satisfaction. A secondary outcome is to achieve a decrease in noise level in non-cardiac operating rooms at this facility, promoting the concept of a 'sterile cockpit' (silence during induction) as borrowed from the aviation industry.
2.0 JUSTIFICATION: Studies have demonstrated that excessive noise in the operating room can be associated with critical error. Additionally, it has been shown that for Anesthesiologists' excessive noise can lead to increased. However, the effects of noise in the OR at the time of induction on patient experience remains unclear. While other validated questionnaires regarding patient satisfaction during the perioperative period have been established, these do not include questions regarding noise levels. Thus, this study will be the first to examine how noise during induction will affect patients' perioperative experience.
This tertiary care facility, St. Paul's Hospital, located in Vancouver, British Columbia, does not have a specific protocol or mandate with respect to noise in the operating room at any time. The recommended decibel levels in OR's is <45 decibels.
3.0 STUDY PURPOSE:
The purpose of this study is to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants are not randomly assigned to a group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or greater
- •Elective, non-cardiac operating room procedure with general anesthesia as the primary mode of anesthesia
排除标准
- •Non-elective surgery
- •Patients who do not receive General Anesthesia
- •Cardiac surgery
- •Significant hearing impairment (self-reported)
- •Significant cognitive impairment
- •Surgeries less than 20 minutes in length
- •Medically unstable postoperatively
- •Anesthesiologist Participants
- •Anesthesiologist Inclusion Criteria:
- •Working in the eligible ORs with eligible patients
结局指标
主要结局
Change in Maximum Noise Levels Pre-/Post-Education
时间窗: The time from patient entering the OR to patient being fully intubated ranged from approximately 5 to 20 minutes. The change is measured between the pre- and post-education phases of the study.
Change in maximum noise levels from pre-education to post-education. Maximum noise levels are measured from the time a patient enters the Operating Room (OR) to the time when the patient is intubated (approximately 5-20 minutes) using an I-phone application (app). The app measures decibel levels and the results were recorded by the anesthesiologist or research assistant.
Change in Average Noise Levels Pre-/Post-Education
时间窗: The time from patient entering the OR to patient being fully intubated ranged from approximately 5 to 20 minutes. The change is measured between the pre- and post-education phases of the study.
Change in average/mean noise levels from pre-education to post-education. Mean noise levels are measured from the time a patient enters the Operating Room (OR) to the time when the patient is intubated (approximately 5-20 minutes) using an I-phone application (app). The app measures decibel levels and the results were recorded by the anesthesiologist or research assistant.
Patient Satisfaction Pre-/Post-Education
时间窗: Patients completed the same surveys in phase 1(pre-education) and phase 3 (post-education). The education was done within a 2 month period after the first phase and before the third phase.
Patients from the pre-education and post-education groups completed the same satisfaction rating survey. The responses were a combination of yes/no responses and likert scales. The 5-point likert scale response options ranged from: "Strongly disagree, Disagree, Not Sure, Agree, Strongly Agree" and "Not At All, A Little Bit, Moderately, Quite A Bit, Extremely". Responses will be compared between groups by question.
次要结局
- Anesthesiologist Satisfaction Pre-/Post-Education(Anesthesiologists completed the same surveys in phase 1(pre-education) and phase 3 (post-education). The education was done within a 2 month period after the first phase and before the third phase.)
研究者
Trina Montemurro
Clinical Assistant Professor
University of British Columbia