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Completed

NCT Number: NCT01612754

Prospective Trial on Noise Reduction in Surgical Operating Theaters

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.

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Key information

Conditions

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

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Surgery Department

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noise reduction work place rules

Behavioral

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.

Other names: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark)

Presence of an examiner in the concerned theatre

Behavioral

Research Clerk present in theatre, writes on note pad.

Primary outcomes

  1. Noise level (dB(A)) in the operation room at the surgeon's place

    Time frame: continous during operation

    noise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace

Secondary outcomes

  1. Surgeons intraoperative biometric and psychometric stress response

    Time frame: before, during and after operations

    Surgeons Cortisol Levels and Electrodermal activity are measured as he/she is submitted to questionnaires.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Technische Universität Dresden
  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 6, 2012
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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