Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees: A Randomized Pilot Simulation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Impact of the optimal sound intensity level during a surgical procedure
研究概览
简要总结
Noise in hospital environments, particularly in operating rooms, poses challenges to both patient comfort and healthcare professionals' performance. Among the sources of noise, anesthesia monitoring alarms are essential for patient safety, yet no clear guidelines exist regarding their optimal sound level. Excessive alarm volume may increase distraction and cognitive load, especially for surgical trainees, potentially impairing their focus and performance during procedures. This randomized pilot interventional study aims to evaluate the impact of anesthesia alarm sound intensity on the mental workload of surgical trainees performing simulated surgeries. Participants will be randomly assigned to conditions with either an optimized alarm volume or a higher standard volume during simulated tasks. Cognitive load will be assessed using objective physiological measures such as heart rate variability and pupillometry, as well as subjective evaluations with tools like the NASA-TLX and SURG-TLX scales. The primary goal is to determine whether an optimized alarm sound level can reduce cognitive strain without compromising vigilance required for patient safety. Findings from this study are expected to provide evidence-based recommendations for auditory ergonomics in operating rooms, ultimately improving working conditions for surgical teams and enhancing both training and patient safety.
详细描述
Noise pollution in hospital environments, particularly within operating rooms (ORs), is a growing concern. It can impact not only the comfort and well-being of patients but also the cognitive performance and concentration of healthcare professionals. Among the various sources of noise, auditory alarms used in anesthesia monitoring are critical for patient safety. However, despite their importance, there are currently no established guidelines or regulations defining the optimal volume at which these alarms should be set.
Previous studies have examined the effects of background noise and music on surgical performance, with some showing that certain types of music can reduce stress or improve focus. However, the specific impact of anesthesia alarm sounds especially when they are excessively loud or frequent remains poorly understood. These alarms may distract surgical teams, particularly trainees, and contribute to increased cognitive load, potentially impairing performance during surgical procedures.
Cognitive load refers to the amount of mental effort being used in working memory. In the operating room, excessive cognitive load can hinder performance, decision-making, and reaction time, particularly in complex or high-pressure situations. Understanding how to manage and optimize environmental factors that influence mental workload is therefore essential, especially for surgical trainees still developing their skills.
This randomized pilot interventional study aims to investigate the effect of anesthesia alarm sound intensity on the mental workload of novice surgeons performing simulated procedures. By focusing on surgical trainees working on a high-fidelity simulator, we aim to create a controlled yet realistic environment to assess the cognitive impact of varying alarm volumes.
The study will compare two conditions: an optimized alarm sound level and a higher-level alarm sound (above ambient noise). Participants will be randomly assigned to one of these conditions during their simulated surgical tasks. The primary outcome is the cognitive load experienced by the trainees under each condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Surgical residents or experienced surgeons;
- •Surgeons with normal hearing;
- •Surgeons capable of performing surgical sutures (regardless of skill level);
- •Surgeons able and willing to follow all study procedures according to the protocol;
- •Surgeons who have understood, signed, and dated the informed consent form provided on the day of enrollment.
排除标准
- •Surgeons undergoing beta-blocker treatment;
- •Surgeons with known cardiac pathology;
- •Surgeons who do not consent to participate in the study;
- •Surgeons with known hearing problems;
- •Surgeons who fail the hearing test;
- •Surgeons who worked on-call or night shifts during the night before the evaluation day.
- •Surgical trainees at the Lorraine Cancer Institute.
- •Adults under legal protection (guardianship, curatorship, or legal supervision);Persons deprived of liberty;Pregnant or breastfeeding women.
研究组 & 干预措施
surgical trainees group
The study group consists of surgical trainees with limited experience in simulated surgery. They will perform multiple 15-minute surgical sequences in a controlled environment, where anesthesia alarm sound levels will vary between 64 and 75 dB(A). These sound levels will be randomized across the sequences to assess the impact of noise on their mental workload, concentration, and surgical performance.
干预措施: effects of sound (Other)
结局指标
主要结局
Impact of the optimal sound intensity level during a surgical procedure
时间窗: From inclusion (baseline) to 6 months post-inclusion
Assessment of heart and respiratory rate variability parameters
次要结局
- Interference with the surgical procedure(From inclusion (baseline) until the end of the surgical procedure)
- Interference with the surgical procedure(From inclusion (baseline) until the end of the surgical procedure)
- Mental workload of the surgical trainee(From inclusion (baseline) until the end of the surgical procedure)