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Prospective Trial on Noise Reduction in Surgical Operating Theaters

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01612754
Enrollment
16
Registered
2012-06-06
Start date
2010-09-30
Completion date
2012-04-30
Last updated
2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Reduction of noise pollution, Specifically enforced workplace rules, Stress, Sound Ears (TM), Error

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.

Interventions

BEHAVIORALNoise reduction work place rules

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.

BEHAVIORALPresence of an examiner in the concerned theatre

Research Clerk present in theatre, writes on note pad.

Sponsors

University of Zurich
CollaboratorOTHER
Technische Universität Dresden
CollaboratorOTHER
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Noise level (dB(A)) in the operation room at the surgeon's placecontinous during operationnoise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace

Secondary

MeasureTime frameDescription
Surgeons intraoperative biometric and psychometric stress responsebefore, during and after operationsSurgeons Cortisol Levels and Electrodermal activity are measured as he/she is submitted to questionnaires.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026