Efficacy of a Noise Reduction ProgramNCT01612754
Prospective Trial on Noise Reduction in Surgical Operating Theaters
A study testing Noise reduction work place rules and Presence of an examiner in the concerned theatre in people with Efficacy of a Noise Reduction Program and Surgical Complications, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy of a Noise Reduction Program, Surgical Complications, Sound Pressures in the Operating Theatre
- What is being tested?
- Noise reduction work place rules and Presence of an examiner in the concerned theatre
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- After hour emergency surgery
- Pediatric surgery cardiac cases
- surgeries <20 mins/>5hrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Efficacy of a Noise Reduction Program, Surgical Complications, Sound Pressures in the Operating Theatre
- Being tested
- Noise reduction work place rules, Presence of an examiner in the concerned theatre
- Keywords
- Reduction of noise pollution, Specifically enforced workplace rules, Stress, Sound Ears (TM), Error
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise reduction work place rulesBehavioural
Also called Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark)
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 theatreBehavioural
Research Clerk present in theatre, writes on note pad.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Noise reduction work place rules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: continous during operation
Secondary outcomes (1)
Surgeons intraoperative biometric and psychometric stress response
Surgeons Cortisol Levels and Electrodermal activity are measured as he/she is submitted to questionnaires.
Measured: before, during and after operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Efficacy of a Noise Reduction ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Technische Universität Dresden
- Responsible party
- Principal investigator, Carsten Engelmann, Hannover Medical School
- Investigators
- Carsten R Engelmann, MD, PhD, Principal investigator, Hannover Medical School, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612754
- Sponsor's protocol ID
- SA 02
- Status last verified
- Jun 2012
- First submitted
- 4 Jun 2012
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22584632Engelmann 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.
PubMed 20835716Shapiro 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.
PubMed 5084988Moorthy 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.
PubMed 15232535Connor 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.
PubMed 20740099Arora 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.
PubMed 20103067
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise Reduction Programme by Work Rules and Technical Devices (i.e.SoundEar-TM)for Surgical Theathres
- ClinicalTrials.gov ID
- NCT01612754
- Acronym / sponsor ID
- SA 02
- Conditions
- Efficacy of a Noise Reduction Program, Surgical Complications, Sound Pressures in the Operating Theatre
- Keywords
- Reduction of noise pollution, Specifically enforced workplace rules, Stress, Sound Ears (TM), Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- University of Zurich, Technische Universität Dresden
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Presence of an examiner in the concerned theatreControl 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 | Experimental | Behavioral: Noise reduction work place rulesIntervention 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- After hour emergency surgery
- Pediatric surgery cardiac cases
- surgeries <20 mins/>5hrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noise reduction work place rulesAlso: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark)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. | Behavioural | Noise Reduction Intervention Group |
| Presence of an examiner in the concerned theatreResearch Clerk present in theatre, writes on note pad. | Behavioural | Control Noise AND Stress measurements |
Primary outcome
Noise level (dB(A)) in the operation room at the surgeon's place
Time frame: continous during operation
noise levels are sampled simultaneously at 4 point (surgeon, nurses 1+2 and anestesiology workplace
1 secondary outcome
Surgeons intraoperative biometric and psychometric stress response
Time frame: before, during and after operations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- Background: PubMed 22584632Conrad 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.
- Background: PubMed 20835716Engelmann 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.
- Background: PubMed 5084988Shapiro 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.
- Background: PubMed 15232535Moorthy 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.
- Background: PubMed 20740099Connor 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.
- Background: PubMed 20103067Arora 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten R Engelmann, MD, PhD principal investigator
Hannover Medical School, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noise reduction work place rules and Presence of an examiner in the concerned theatre in people with Efficacy of a Noise Reduction Program and Surgical Complications, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise level (dB(A)) in the operation room at the surgeon's place (time frame: continous during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612754, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.