Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04722497 |
| Other study ID # |
HSR200262 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
January 2021 |
| Source |
University of Virginia |
| Contact |
Megan Whitham, MD |
| Phone |
7038197703 |
| Email |
mw8rf[@]hscmail.mcc.virginia.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
During Phase I, disguised SoundEar noise devices will be used to record the noise levels in
the operating rooms on Labor and Delivery during Cesarean births. Survey data will be
acquired from physicians, nurses, and patients to determine if the sound in the operating
rooms during surgery impacted the stress levels of those involved. An educational
intervention will then be held for the physicians and nurses, and Phase II will involve
having the SoundEar devices exposed. When the sound level reaches a distracting level, the
light on the device will change to bright red. Surveys will be collected to determine if
there is a difference in the stress levels if and when the noise level in the operating room
is decreased during cesarean births.
Description:
For noise measurement and visual feedback, a SoundEar III device will be used. The SoundEar
is the most studied and supported AV device maker in medical literature, with option of
recording and providing visual feedback, designed specifically to "create awareness about
noise". The device measures the environmental sound continuously and is also able to provide
visual feedback indicating the actual sound level and has been extensively studied for uses
in the clinical setting.
The technical specifications of the device are as follows: frequency range 20Hz to 16kHz and
scope of measurement of 45dB(A) (similar to bird calls) to 115dB(A) (a sound level that can
be encountered at a live rock music venue). The system provides optical feedback in 3
categories: green light (acceptable noise level), orange light (noise level is near the
limit) and red light (noise level has exceeded the limit).
The L&D ORs will be equipped with a sound measurement feedback device mounted on the wall
visible from the foot end of the operating table. Noise recording can be conducted
continuously for 24 hours a day, and downloaded, stored and analyzed weekly. The recorded
sound level data can be time-matched with corresponding operations during time stamps.
The study will be divided into 4 phases.
Initially, a baseline validated Weinstein Noise Sensitivity questionnaire (WNS-6B) for
subjective noise sensitivity will be collected for all potentially included primary resident
surgeons9 as the variability in noise annoyance/disturbance is often best explained by
individual subjective noise sensitivity than true noise level.
In phase 1, over a 4-6 month period, we will measure noise decibel level with the noise meter
continuously with the optical feedback function concealed and pair this with all scheduled
and unscheduled C-sections in the L&D OR. The surgical team members will not specifically be
told that data is being collected for a study, but the SoundEar devices will be visible to
the surgical team during this phase. We will then plan to collect brief scale questionnaires
on a visual analog scale adapted from Engelmann, et al. for all included study cases from the
primary resident surgeon, the circulating RN and the patient regarding perceived noise level,
stress level and overall experience. . Health care team members will serve as their own
nested controls and thus the questionnaires will be de-identified and paired with a unique
study ID number generated for each participant---- please note that the first page will only
ask for the respondent's name and the questionnaire on the second page will not contain
identifying information with the intention of removing the respondents name after their
unique identifier has been transcribed to the questionnaire. These cases will serve as nested
controls with each provider submitting a response serving as their own baseline control
during statistical analysis and will be able to be linked to operative details and patient's
chart from date and time noted for the delivery by the respondent. No identifying patient
information will be collected on any of the paper questionnaires. Details about: case length,
number of attendees in the operating room, blood loss, intraoperative complications, NICU
involvement, NICU admission, maternal and neonatal length of stay, postoperative
complications, readmissions, and reoperations will be obtained from the patient's chart in a
prospective manner.
Each patients who consents to be in the study will complete one questionnaire. The patient
will be informed that we are recording the noise levels in the OR during their surgery, and
that we are studying the impact of noise levels in the OR on patient and physician stress
levels and surgical outcomes.
Examples of the questionnaires are included with this application. The primary RN will also
record the case type (scheduled, unplanned, urgent, or emergent), date and case start and
stop time for time stamp reference, number of staff members in the L&D OR and pertinent
pediatric outcome data (APGAR, gestational age, NICU admission) in his/her portion of the
survey. These cases will serve as "controls" and baseline noise data.
A two week washout period will then be planned during which no data will be collected. A
difference in noise reduction of 3dB(A) is an important noise level reduction level as it
represents a 50% reduction in perceived noise levels. A power calculation can be performed
after phase 1 to calculate needed cases to demonstrate a statistical difference in noise
reduction with intervention. From the literature, with an average decibel level of roughly 60
dB, and S.D. of 10 dB, 87 cases would be required to demonstrate statistical significance at
80% power.
In phase 2, the visual feedback function will be activated on the noise meters. Providers
will be aware of the introduction of the device but receive no formal noise reduction
education or knowledge that a study is being conducted in this phase. A threshold of ≤60dB(A)
is generally accepted as an "acceptable" level and ≥65dB(A) as an excessive noise level based
on the system providers recommendations and per results from previous studies in the medical
literature. Optical feedback can then be accordingly activated in these 3 ranges (green light
≤60dB(A), orange light from 60-65dB(A), red light ≥65dB(A)). Similarly, we will collect
overall noise data continuously during phase 2 and pair this with all scheduled and
unscheduled C-sections in the L&D OR with questionnaire data collected for comparison to the
pre-intervention period.
For statistical analysis, surgeons and RN team members will be compared in nested control
manner from the preintervention to postintervention time periods with planned sub-analysis of
"high-responders" and "low-responders" from results of their previously obtained subjective
WNS-6B questionnaires.
After data collection for phase 2, a phase 3 and 4 intervention period may be planned with
intervening washout periods. These phases will take place after a 2 week formal education
program on noise reduction, combined with the visual feedback function first disabled and
then enabled with similar recording of continuous noise decibel level and survey data. The
purpose of phase 3 and 4 will be in comparing outcomes from simple introduction of the device
versus combined education program on noise awareness. The noise awareness program will also
include a prompt that incorporation of noise reduction efforts are ongoing during
preoperative time out. Initial sub-analysis of phase 1&2 data should be planned for
evaluating efficacy of the visual feedback device alone at improvement in noise outcomes
(manuscript #1). Surgical and pediatric outcomes data will also be measured during all time
periods for evaluation.
If the intervention is successful at improvement in surgeon stress or patient outcomes, the
AV feedback noise meters may be considered for long term adoption into the L&D ORs and future
investigation of effectiveness in the Labor and Delivery Room (LDR) during vaginal births
could be planned.
