Clinical trial NCT01612754: Prospective Trial on Noise Reduction in Surgical Operating Theaters
Official title: Noise Reduction Programme by Work Rules and Technical Devices (i.e.SoundEar-TM)for Surgical Theathres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy of a Noise Reduction Program
Surgical Complications
Sound Pressures in the Operating Theatre
Keywords: Reduction of noise pollution
Specifically enforced workplace rules
Stress
Sound Ears (TM)
Error
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Technische Universität Dresden
First posted: 2012-06-06
Enrollment: 16
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Noise level (dB(A)) in the operation room at the surgeon's place
timeFrame: continous during operation
Secondary outcomes:
measure: Surgeons intraoperative biometric and psychometric stress response
timeFrame: before, during and after operations
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Pediatric Surgery Department
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School, Germany
name: Carsten R Engelmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Engelmann C, Schneider M, Kirschbaum C, Grote G, Dingemann J, Schoof S, Ure BM. Effects of intraoperative breaks on mental and somatic operator fatigue: a randomized clinical trial. Surg Endosc. 2011 Apr;25(4):1245-50. doi: 10.1007/s00464-010-1350-1. Epub 2010 Sep 11.
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citation: Arora S, Hull L, Sevdalis N, Tierney T, Nestel D, Woloshynowych M, Darzi A, Kneebone R. Factors compromising safety in surgery: stressful events in the operating room. Am J Surg. 2010 Jan;199(1):60-5. doi: 10.1016/j.amjsurg.2009.07.036.