NCT01612754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

June 4, 2012

Last Update Submit

June 5, 2012

Conditions

Efficacy of a Noise Reduction ProgramSurgical ComplicationsSound Pressures in the Operating Theatre

Keywords

Reduction of noise pollutionSpecifically enforced workplace rulesStressSound Ears (TM)Error

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Surgeons intraoperative biometric and psychometric stress response

    before, during and after operations

Study Arms (3)

Reference group - cloaked noise meters

NO INTERVENTION

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

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

Noise Reduction Intervention Group

EXPERIMENTAL

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

Interventions

Noise reduction work place rulesBEHAVIORAL

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.

Also known as: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark)
Noise Reduction Intervention Group
Presence of an examiner in the concerned theatreBEHAVIORAL

Research Clerk present in theatre, writes on note pad.

Control Noise AND Stress measurements

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • After hour emergency surgery
  • Pediatric surgery cardiac cases
  • surgeries \<20 mins/\>5hrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Surgery Department

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (6)

  • 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.

    PMID: 22584632BACKGROUND

  • 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.

    PMID: 20835716BACKGROUND

  • 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.

    PMID: 5084988BACKGROUND

  • 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.

    PMID: 15232535BACKGROUND

  • 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.

    PMID: 20740099BACKGROUND

  • 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.

    PMID: 20103067BACKGROUND

Study Officials

  • Carsten R Engelmann, MD, PhD

    Hannover Medical School, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt Kinderchirurgie

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Study Completion

April 1, 2012

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

DE(1)