Prospective Trial on Noise Reduction in Surgical Operating Theaters

Hannover Medical School (MHH)

Status: Completed

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

Treatments: Behavioral: Presence of an examiner in the concerned theatre; Behavioral: Noise reduction work place rules

Study type: Interventional

Funder types: Other

Identifiers

NCT01612754

SA 02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups

Reference group - cloaked noise meters

No Intervention group

Description:

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.

Control Noise AND Stress measurements

Sham Comparator group

Description:

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

Treatment:

Behavioral: Presence of an examiner in the concerned theatre

Noise Reduction Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Noise reduction work place rules