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Noise ExposureNCT04638296

Perceptions On Music And Noise In The OR

An observational study of Noise Exposure and Surgical Procedure, Unspecified, run by American University of Beirut Medical Center at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Noise in operating rooms (ORs) during surgery may affect OR personnel and pose a threat to patient safety. The sources of noise vary depending on the operation. We aimed to study how OR staff perceived noise, whether music was considered noise and what its perceived effects were. Read more about this study

Who is it for?
Any age
What is being tested?
Interviews
How many people
91 participants
Where
1 siteLebanon
Study dates
1 Jan 2019to 1 Jan 2020
Phase
Observational
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: All OR staff were eligible for recruitment, including surgeons, anesthesiologists, residents and nurses. There were no exclusion criteria per se; however, the interview had to be conducted on the day the participant was involved in a surgical operation.

All OR staff were eligible for recruitment

Trial locations and contacts

1 site in 1 country.

Lebanon1 site
  • American University of Beirut Medical Center

    Beirut

Other trials in Lebanon

About this study

Official title: Perceptions On Music And Noise In The Operating Room: A Cross Sectional Study

Background: Noise in operating rooms (ORs) during surgery may affect OR personnel and pose a threat to patient safety. The sources of noise vary depending on the operation. We aimed to study how OR staff perceived noise, whether music was considered noise and what its perceived effects were.

Methods: Surgeons, anesthesiologists, residents, and nurses were interviewed. IPads were placed in the ORs to gather noise level data.

Read the detailed description
  1. Introduction High noise levels in the operating rooms (ORs) during surgery may pose a major threat to the safety and efficiency of procedures performed [1]. The recommended threshold for noise should not exceed 90 dBA over an 8 hour period to prevent noise induced hearing loss [2]. Unfortunately, in 40% of surgeries, OR noise levels reach and exceed 100-120 dBA [2], comparable to a busy highway (1). High noise levels affect both patients and staff: patients may suffer from intraoperative hypertension and tachycardia [3], and prolonged exposure of staff to OR noise has been linked to noise induced hearing loss [4,5], to interference with communication in the OR (6) and to decrements in surgeons' concentration and vigilance [4,7,8]. Sources of noise in the OR stem primarily from (a) surgical instruments including high speed pneumatic drills, chisels, hammers, and saws [9], (b) equipment such as vital sign monitors, alarms, ventilators, anesthesia machines, waste management devices, and radiological equipment [6] and (c) conversations amongst the staff [4]. Clanging, clattering or dropping metal instruments is also another source of noise [1]. In addition to the above, music is occasionally played in ORs, often requested and chosen by the operating surgeon; whether music qualifies as just more noise is debatable [5]. There have been mixed reports on the effect of music on personnel performance, concentration, communication, speed and cooperation [8, 10-16]. Proponents of music claim that it masks some of the noise, has a calming effect, improves motivation, increases accuracy, and reduces stress [1, 11, 12, 14, 15, 17]. A review of the literature describes the effect of music as contributing to overall stress of the environment, interfering with communication, and posing a threat to the safety of patient and staff as well as to task completion [5]. The literature is lacking in research on the effects of music as a distractor during operations, especially given the likelihood of unexpected stressful intraoperative complications [18]. It is not clear if at a critical time in a race against the clock, music incentivizes the surgeon and OR staff or if it exacerbates their stress and distracts them. Our aim was to determine how surgeons, anesthesiologists, residents and nurses perceived the presence of noise and music in the operating room and how they thought it affected their performance, concentration and communication. The results of this study will guide the design of a follow up study to determine the effects of music on outcomes of specific procedures.
  2. Material and Methods 2.1 Study design and setting:

This was an observational, cross sectional study between January 2019-January 2020 of OR personnel's perceptions of noise and music in the ORs at a tertiary academic institution in Beirut, Lebanon. Interviews were conducted in the privacy of the physician's lounge or in a private location within the hospital at the participant's convenience. IPads were placed in all of the center's ten ORs. They were placed in the corner of the ORs away from the working areas and mounted on the walls to avoid interference with the work of the staff.

This research is reported in line with the STROCSS guideline [19].

2.2 Participants:

All OR staff were eligible for recruitment, including surgeons, anesthesiologists, residents and nurses. There were no exclusion criteria per se; however, the interview had to be conducted on the day the participant was involved in a surgical operation.

2.3 Sample Size:

The sample size was estimated at 85 participants. This value was based on a correlation sample size calculation, with a Type I error rate of 0.05, Type II error rate of 0.2, and an expected correlation coefficient of 0.3. Data for this study was collected from 91 participants to err on the side of caution and to maintain heterogeneity among the different staff groups.

2.4 Recruitment:

Participants were recruited via a scripted invitation email detailing the specifics of the study sent by the IT Academic Core Processes and Systems (ACPS) on behalf of the investigating team per ethical research conduct guidelines. Willing potential participants were asked to contact the study team for any questions and to schedule a private meeting for the interview at their convenience. Participation was entirely voluntary, and interviews were conducted following the participants' explicit written consent. Some interviews were audio recorded following participant's consent; otherwise, the interviewer took notes. Interviews lasted approximately 20 minutes.

2.5 Instruments:

Semi Structured Interview Guide The investigators designed 3 versions of the semi structured interview guide for each of the surgeons/anesthesiologists.1), residents and nurses . 3). All versions were subdivided into 3 general categories: 1) participant demographics such as participant's age, years of experience, specialty, years of employment at the institution 2) participant's perceptions of noise in the OR, what they considered as sources of noise, the loudness level, whether they thought this impacted their concentration, performance, communication, whether this was distracting or helpful in different stages of the operation, and 3) perceptions on music.

Most questions were closed ended: effects of noise/music on concentration, performance and communication, and levels of loudness. Answers were rated on 3- point Likert scales (3-Positively, 2- Neutral, 1-Negatively and 3-High, 2- Moderate, 1- Low, respectively). These were followed by open ended questions referring to the potential effects of noise and music: 1. At which times during surgery do you find music helpful, and why? and 2. At which times during surgery do you find music distracting? Answers to these questions were reviewed and collated thematically.

IPads IPads installed in the ORs were placed in a thin plastic bag in the corner of each operating room. This is to ensure that the iPads did not interfere with the work of the staff. The iPads were iPad Air Wi-Fi 64 GB. The application "Sound Affects" was installed on the iPads and used to extract the noise data. The application was developed by Memac Ogilvy for the institution based on technical requirements from the Patient Affairs Unit. It uses the built in microphone of the iPad hence accounting for the relative loudness perceived by the human ear, which is known as A-weighting value.

2.6 Statistical Analyses:

Quantitative data from interviews was entered into the Statistical Package for Social Sciences (SPSS) version 24 (IBM Corp.) for analysis. Descriptive analyses were carried out using the number and percent for categorical variables and mean and standard deviation for continuous variables and analyzing the noise level data gathered from the sensors and iPads. Pearson Chi square and correlation tests were performed to test for relationships. Narrative responses to open ended questions were categorized thematically.

Being tested
Interviews
Keywords
Music, Operating Room, Noise, Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterviewsOther

    The investigators designed 3 versions of the semi structured interview guide for each of the surgeons/anesthesiologists (Appendix A.1), residents (Appendix A.2) and nurses (Appendix A. 3). All versions were subdivided into 3 general categories: 1) participant demographics such as participant's age, years of experience, specialty, years of employment at the institution 2) participant's perceptions of noise in the OR, what they considered as sources of noise, the loudness level, whether they thought this impacted their concentration, performance, communication, whether this was distracting or helpful in different stages of the operation, and 3) perceptions on music.

Study groups in NCT04638296
Study groupRoleWhat they receive
Physicianssurgeons, anesthesiologists, and surgical residents
Receives: Other: Interviews
NursesOR Nurses
Receives: Other: Interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceptions on Noise in the OR

    Via an interview participants were asked about their perception on noise in the OR, the sources of noise and how it affected their performance, concentration and communication.

    Measured: 1 year

  2. Perceptions on Music in the OR

    Via an interview participants were asked about their perception on music in the OR, the sources of noise and how it affected their performance, concentration and communication.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638296
Sponsor's protocol ID
SBS-2018-0310
Status last verified
Nov 2020
First submitted
9 Nov 2020
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Noise Exposure and Surgical Procedure, Unspecified, run by American University of Beirut Medical Center at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. 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 Lebanon. 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. 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?

Perceptions on Noise in the OR (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Nov 2020.

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