Prospective Trial on Noise Reduction in Surgical Operating Theaters

Not Applicable

Completed

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

• Registration Number: NCT01612754
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-11
• Study Completion: 2012-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-06
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Noise AND Stress measurements	Presence of an examiner in the concerned theatre	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
Noise Reduction Intervention Group	Noise reduction work place rules	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pediatric Surgery Department; 🇩🇪 Hannover, Lower Saxony, Germany