Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04638296 |
| Other study ID # |
SBS-2018-0310 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
American University of Beirut Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
Methods: Surgeons, anesthesiologists, residents, and nurses were interviewed. IPads were
placed in the ORs to gather noise level data.
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.
