Noise Reduction Programme by Work Rules and Technical Devices (i.e.SoundEar-TM)for Surgical Theathres
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Noise level (dB(A)) in the operation room at the surgeon's place
研究概览
简要总结
Aim of Study: Adverse effects from noise pollution in operation theatres have been throughly demonstrated. We assessed the impact of a noise reduction program in paediatric surgery.
Methods: A prospective controlled study on 156 operations performed by 16 surgeons was conducted. The sound levels before and after a noise reduction program based on education, rules and technical devices (Sound Ear tm) were assessed. Endpoints were spatially resolved sound levels matched by the surgeon's biometric (saliva cortisol, electrodermal activity) and behavioural stress responses (questionnaires). These were correlated with mission protocols and NoiSeQ for individual noise sensitivity.
详细描述
We recorded median noise levels in the control vs. interventional group including the count of peak events with different tresholds.
Three phases were conducted: 1. Reference group/phase I 2. Control group/phase II The full data set was recorded by a research clerk present in theatre however all staff were left unaware of the study purpose 3. Intervention group/phase III. The intervention consisted of a panel of work rules including mainly communication regulations (only conversations concerning the current case were allowed, no in and out during surgery, mobile phone ban etc.. Measures were backed by intervention conferences, posters and pictograms. .
A wear off-effect was sought after . Biometrically, we analyzed the surgeon's pre- to postoperative rise in cortisol and the proportion of the surgeon's electrodermal potentials of >15µS indicating severe stress. Intra-team communication, a decrease in disturbing conversations and sudden noise peaks were investigated and correlated with the individual noise sensitivity determined by the noise Q questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all operations of our tertiary referral center practice of the regular day programme involving children from preterm babies up to children of 16 years of age including emergencies at regular hours with a duration of > 20 mins and < 5 hours
排除标准
- •After hour emergency surgery
- •Pediatric surgery cardiac cases
- •surgeries <20 mins/>5hrs
研究组 & 干预措施
Reference group - cloaked noise meters
Reference group or phase 1
Theatre equipped with multiple sound meters disguised as CO2 meter for sound probing in the absence of a research clerk with personnel completely unaware of sound measurements.
Control Noise AND Stress measurements
Control Group - Phase 2
No intervention but research clerk is present in theatre to protocoll the operation and test for stress by collecting saliva cortisol and probing electrodermal activity
干预措施: Presence of an examiner in the concerned theatre (Behavioral)
Noise Reduction Intervention Group
Intervention Group - Phase 3
A panel of noise reduction measures (staff workplace rules, technical devices as optical noise warners, optical telephones) is put into effect. Surgeons are monitored by biometry, psychometry and the outcome.
干预措施: Noise reduction work place rules (Behavioral)
结局指标
主要结局
Noise level (dB(A)) in the operation room at the surgeon's place
时间窗: continous during operation
noise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace
次要结局
- Surgeons intraoperative biometric and psychometric stress response(before, during and after operations)
研究者
Carsten Engelmann
Oberarzt Kinderchirurgie
Hannover Medical School