CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Noise reduction work place rules +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT01612754
NCT01612754N/ACompleted

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

Hannover Medical School·interventional·Posted Jun 6, 2012·Updated Jun 6, 2012

In Brief

A clinical study evaluating Noise reduction work place rules and Presence of an examiner in the concerned theatre for Efficacy of a Noise Reduction Program and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2012
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago

Interventions

Noise reduction work place rulesbehavioral

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.

Presence of an examiner in the concerned theatrebehavioral

Research Clerk present in theatre, writes on note pad.