Prospective Trial on Noise Reduction in Surgical Operating Theaters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Noise Reduction Programme by Work Rules and Technical Devices (i.e.SoundEar-TM)for Surgical Theathres

Conditions
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Efficacy of a Noise Reduction Program, Surgical Complications, Sound Pressures in the Operating Theatre

Intervention / Treatment
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* Behavioral: Noise reduction work place rules
* Behavioral: Presence of an examiner in the concerned theatre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: After hour emergency surgery Pediatric surgery cardiac cases surgeries <20 mins/>5hrs

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Reference group - cloaked noise meters<br>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. | |
| Sham Comparator: Control Noise AND Stress measurements<br>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 | Behavioral: Presence of an examiner in the concerned theatre<br>* Research Clerk present in theatre, writes on note pad.<br>|
| Experimental: Noise Reduction Intervention Group<br>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. | Behavioral: Noise reduction work place rules<br>* Information conferences for all theatre staff (100%)on the detrimal effects of high noise levels in the operating theatre. Issue of workplace rules on handouts and poster on theatre doors: Ban of all mobile phones from theatre. Only conversations about the ongoing case are allowed. No restocking etc. during an operation and no work in this operating room concerning other patients (e.g. later on the list). Turnig of of unnecessary suckers, warming devices etc. . No in and out during the procedure. Technical: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark) taped to all 4 Walls. Optical Telephones.<br>* Other names: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noise level (dB(A)) in the operation room at the surgeon's place | noise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace | continous during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeons intraoperative biometric and psychometric stress response | Surgeons Cortisol Levels and Electrodermal activity are measured as he/she is submitted to questionnaires. | before, during and after operations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduction of noise pollution, Specifically enforced workplace rules, Stress, Sound Ears (TM), Error