Prospective Trial on Noise Reduction in Surgical Operating Theaters

Surgical Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612754
• Other study ID #: SA 02
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: June 5, 2012
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

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.
• Presence of an examiner in the concerned theatre
Research Clerk present in theatre, writes on note pad.

Locations

Country	Name	City	State
Germany	Pediatric Surgery Department	Hannover	Lower Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	Technische Universität Dresden, University of Zurich

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

Connor A, Ortiz E. Staff solutions for noise reduction in the workplace. Perm J. 2009 Fall;13(4):23-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shapiro RA, Berland T. Noise in the operating room. N Engl J Med. 1972 Dec 14;287(24):1236-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No