HSR200262-Effectiveness of a Visual Noise Warning System on Noise Levels in the Labor and Delivery Operating Room: A Quality Improvement Program
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Reducing Noise Levels in the Operating Room
研究概览
简要总结
During Phase I, disguised SoundEar noise devices will be used to record the noise levels in the operating rooms on Labor and Delivery during Cesarean births. Survey data will be acquired from physicians, nurses, and patients to determine if the sound in the operating rooms during surgery impacted the stress levels of those involved. An educational intervention will then be held for the physicians and nurses, and Phase II will involve having the SoundEar devices exposed. When the sound level reaches a distracting level, the light on the device will change to bright red. Surveys will be collected to determine if there is a difference in the stress levels if and when the noise level in the operating room is decreased during cesarean births.
详细描述
For noise measurement and visual feedback, a SoundEar III device will be used. The SoundEar is the most studied and supported AV device maker in medical literature, with option of recording and providing visual feedback, designed specifically to "create awareness about noise". The device measures the environmental sound continuously and is also able to provide visual feedback indicating the actual sound level and has been extensively studied for uses in the clinical setting.
The technical specifications of the device are as follows: frequency range 20Hz to 16kHz and scope of measurement of 45dB(A) (similar to bird calls) to 115dB(A) (a sound level that can be encountered at a live rock music venue). The system provides optical feedback in 3 categories: green light (acceptable noise level), orange light (noise level is near the limit) and red light (noise level has exceeded the limit).
The L&D ORs will be equipped with a sound measurement feedback device mounted on the wall visible from the foot end of the operating table. Noise recording can be conducted continuously for 24 hours a day, and downloaded, stored and analyzed weekly. The recorded sound level data can be time-matched with corresponding operations during time stamps.
The study will be divided into 4 phases.
Initially, a baseline validated Weinstein Noise Sensitivity questionnaire (WNS-6B) for subjective noise sensitivity will be collected for all potentially included primary resident surgeons9 as the variability in noise annoyance/disturbance is often best explained by individual subjective noise sensitivity than true noise level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •the resident surgeon who performs a cesarean section, the resident anesthesiologist, the attending OBGYN and Anesthesiologist, the nurse who is the primary nurse for the patient, and the patient who is undergoing a cesarean section
排除标准
- •At the nurse/physician's discretion, any patient who has suffered a fetal loss or has another serious complication that causes too much stress to expect them to participate in the study.
结局指标
主要结局
Reducing Noise Levels in the Operating Room
时间窗: 1 year
Our primary outcome to measure will be noise decibel level over the study time period with a primary end-point of a 3 point reduction in noise decibel level which represents a reduction of 50% perceived noise level.We plan to use univariate and multivariate analysis for our primary outcomes measures of noise reduction.
次要结局
- Noise Disturbance in the Operating Room(1 year)
研究者
Megan Whitham, MD
Maternal Fetal Medicine fellow
University of Virginia