Noise in the OR: A Quality Improvement Program

NCT04722497 | Unknown

• 1 other identifier: HSR200262
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Noise; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• Reducing Noise Levels in the Operating Room

  Our primary outcome to measure will be noise decibel level over the study time period with a primary end-point of a 3 point reduction in noise decibel level which represents a reduction of 50% perceived noise level.We plan to use univariate and multivariate analysis for our primary outcomes measures of noise reduction.

  1 year

Secondary Outcomes (1)

• Noise Disturbance in the Operating Room

  1 year

Study Arms (2)

Physicians and nurses

All physicians, nurses, involved in a cesarean births are included in the cohort.

Other: Sound Education

Patients undergoing cesarean births

All patients undergoing cesarean births

Interventions

Sound Education OTHER

All physicians and nurses involved in cesarean births will be given an education intervention explaining the impact of noise levels on stress and focus. The SoundEar device will be used as an intervention tool to inform operating room physicians and nurses when the noise level is above the desired level.

Physicians and nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the resident surgeon who performs a cesarean section, the resident anesthesiologist, the attending OBGYN and Anesthesiologist, the nurse who is the primary nurse for the patient, and the patient who is undergoing a cesarean section

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Officials

• Megan J Whitham, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Whitham, MD

CONTACT

7038197703; mw8rf@hscmail.mcc.virginia.edu

Amanda Urban, MS

CONTACT

4344093100; ajr5y@hscmail.mcc.virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine fellow

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)