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

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 Overview

• Status: Completed
• Conditions: Surgical Complications; Efficacy of a Noise Reduction Program; Sound Pressures in the Operating Theatre
• Intervention / Treatment: Behavioral: Presence of an examiner in the concerned theatre; Behavioral: Noise reduction work place rules

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Pediatric Surgery department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Reference group - cloaked noise meters; Reference group or phase 1 Theatre equipped with multiple sound meters disguised as CO2 meter for sound probing in the absence of a research clerk with personnel completely unaware of sound measurements.
Sham Comparator: Control Noise AND Stress measurements; Control Group - Phase 2 No intervention but research clerk is present in theatre to protocoll the operation and test for stress by collecting saliva cortisol and probing electrodermal activity	Behavioral: Presence of an examiner in the concerned theatre; Research Clerk present in theatre, writes on note pad.
Experimental: Noise Reduction Intervention Group; Intervention Group - Phase 3 A panel of noise reduction measures (staff workplace rules, technical devices as optical noise warners, optical telephones) is put into effect. Surgeons are monitored by biometry, psychometry and the outcome.	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.; Other Names: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise level (dB(A)) in the operation room at the surgeon's place	noise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace	continous during operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeons intraoperative biometric and psychometric stress response	Surgeons Cortisol Levels and Electrodermal activity are measured as he/she is submitted to questionnaires.	before, during and after operations

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: University of Zurich; Technische Universität Dresden
• Investigators: Principal Investigator: Carsten R Engelmann, MD, PhD, Hannover Medical School, Germany

Publications and helpful links

General Publications

• Conrad C, Konuk Y, Werner PD, Cao CG, Warshaw AL, Rattner DW, Stangenberg L, Ott HC, Jones DB, Miller DL, Gee DW. A quality improvement study on avoidable stressors and countermeasures affecting surgical motor performance and learning. Ann Surg. 2012 Jun;255(6):1190-4. doi: 10.1097/SLA.0b013e318250b332.
• 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.
• Shapiro RA, Berland T. Noise in the operating room. N Engl J Med. 1972 Dec 14;287(24):1236-8. doi: 10.1056/NEJM197212142872407. No abstract available.
• Moorthy K, Munz Y, Undre S, Darzi A. Objective evaluation of the effect of noise on the performance of a complex laparoscopic task. Surgery. 2004 Jul;136(1):25-30; discussion 31. doi: 10.1016/j.surg.2003.12.011.
• Connor A, Ortiz E. Staff solutions for noise reduction in the workplace. Perm J. 2009 Fall;13(4):23-7. doi: 10.7812/TPP/09-057.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Stress; Reduction of noise pollution; Specifically enforced workplace rules; Sound Ears (TM); Error
• Other Study ID Numbers: SA 02