Noise in the OR: A Quality Improvement Program (NCT04722497) | Clinical Trial Compass
UnknownNot Applicable
Noise in the OR: A Quality Improvement Program
United States1,200 participantsStarted 2021-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.