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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
Sponsor:
Information provided by (Responsible Party):
Megan Whitham, MD, University of Virginia

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.

Condition or disease Intervention/treatment
Noise; Adverse Effect Other: Sound Education

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria: 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

Exclusion Criteria:At the nurse/physician's discretion, any patient who has suffered a fetal loss or has another serious complication that causes too much stress to expect them to participate in the study.

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Information from the National Library of Medicine

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


Contacts
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Contact: Megan Whitham, MD 7038197703 mw8rf@hscmail.mcc.virginia.edu
Contact: Amanda Urban, MS 4344093100 ajr5y@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Megan J Whitham, MD University of Virginia
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Responsible Party: Megan Whitham, MD, Maternal Fetal Medicine fellow, University of Virginia
ClinicalTrials.gov Identifier: NCT04722497    
Other Study ID Numbers: HSR200262
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No