Prospective Trial on Noise Reduction in Surgical Operating Theaters
NCT01612754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2012-06-06
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.
Conditions
- Efficacy of a Noise Reduction Program
- Surgical Complications
- Sound Pressures in the Operating Theatre
Interventions
- BEHAVIORAL
-
Noise 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.
- BEHAVIORAL
-
Presence of an examiner in the concerned theatre
Research Clerk present in theatre, writes on note pad.
Sponsors & Collaborators
-
University of Zurich
collaborator OTHER -
Technische Universität Dresden
collaborator OTHER -
Hannover Medical School
lead OTHER
Principal Investigators
-
Carsten R Engelmann, MD, PhD · Hannover Medical School, Germany
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2011-11-30
- Completion
- 2012-04-30
Countries
- Germany
Study Locations
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