Noise in the OR: A Quality Improvement Program
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|ClinicalTrials.gov Identifier: NCT04722497|
Recruitment Status : Not yet recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
|Condition or disease||Intervention/treatment|
|Noise; Adverse Effect||Other: Sound Education|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||HSR200262-Effectiveness of a Visual Noise Warning System on Noise Levels in the Labor and Delivery Operating Room: A Quality Improvement Program|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||December 2023|
Physicians and nurses
All physicians, nurses, involved in a cesarean births are included in the cohort.
Other: Sound Education
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.
Patients undergoing cesarean births
All patients undergoing cesarean births
- Reducing Noise Levels in the Operating Room [ Time Frame: 1 year ]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.
- Noise Disturbance in the Operating Room [ Time Frame: 1 year ]Our secondary measured outcomes will be a significant measurable reduction in patient and healthcare team member noise disturbance as measured by Likert scale questionnaires targeting OR experience.We will use ranked match sums for survey analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722497
|Contact: Megan Whitham, MDfirstname.lastname@example.org|
|Contact: Amanda Urban, MSemail@example.com|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Megan J Whitham, MD||University of Virginia|