- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739746
Research on the Sources of Noise in Post Anesthesia Care Unit and the Impact of Noise on Medical Staff
May 29, 2025 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University
The study aims to clarify the sources and influencing factors of noise in the post anesthesia care unit, as well as the perception of noise by medical staff through survey table, in order to improve the noise environment, optimize noise management, protect medical staff, and enhance medical quality.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Su Min Min
- Phone Number: 8613568235251
- Email: atpcr7@yeah.net
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Medical staff in the post anesthesia care unit
Description
Inclusion Criteria:
- Currently working as nurses, doctors, or technicians in the Post Anesthesia Care Unit;
- Have at least continuous 6 months of work experience in the Post Anesthesia Care Unit;
- Able to read and answer questionnaires in Chinese fluently.
Exclusion Criteria:
- Have hearing impairments or other conditions affecting auditory perception;
- Have participated in similar studies and completed related surveys within the past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Medical staff group
Investigate the demographic information and subjective perception of noise among medical staff in the post anesthesia care unit.
|
No intervention measures
|
|
Hospital Group
Investigate the staffing, size, number of beds, noise levels, etc. of post anesthesia care unit in different hospitals.
|
No intervention measures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Main noise decibel
Time Frame: From enrollment to the end of observation at 1 week
|
The level of noise decibel in the post anesthesia care unit when the number of patients is between half and three-quarters of the total number of beds.
Using noise vibration measuring instrument (AWA5688, Hangzhou Aihua Instrument Co., Ltd.) to measure the noise decibel.
|
From enrollment to the end of observation at 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary noise decibel
Time Frame: From enrollment to the end of observation at 1 week
|
The level of noise decibel in the post anesthesia care unit when the number of patients is not between half and three-quarters of the total number of beds.
Using noise vibration measuring instrument (AWA5688, Hangzhou Aihua Instrument Co., Ltd.) to measure the noise decibel.
|
From enrollment to the end of observation at 1 week
|
|
Area of post anesthesia care unit
Time Frame: From enrollment to the end of observation at 1 week
|
Measure the area of the post anesthesia care unit using a tape measure, in square meters.
|
From enrollment to the end of observation at 1 week
|
|
Number of beds of post anesthesia care unit
Time Frame: From enrollment to the end of observation at 1 week
|
From enrollment to the end of observation at 1 week
|
|
|
Medical personnel allocation situation
Time Frame: From enrollment to the end of observation at 1 week
|
Number of anesthesiologists and nurses
|
From enrollment to the end of observation at 1 week
|
|
Staying time in post anesthesia care unit of patients
Time Frame: From enrollment to the end of observation at 1 week
|
From enrollment to the end of observation at 1 week
|
|
|
Number of patients with or without tracheal intubation retained
Time Frame: From enrollment to the end of observation at 1 week
|
Defined as patients whether retaining the endotracheal tube before entering the post anesthesia care unit
|
From enrollment to the end of observation at 1 week
|
|
Daily working hours of medical staff
Time Frame: From enrollment to the end of observation at 1 week
|
From enrollment to the end of observation at 1 week
|
|
|
Working years of medical staff
Time Frame: From enrollment to the end of observation at 1 week
|
From enrollment to the end of observation at 1 week
|
|
|
Subjective perception of noise by medical personnel
Time Frame: From enrollment to the end of observation at 1 week
|
Using multiple-activity scale for hyperacusis (MASH) that is proposed by Dauman in 2005 to evaluate emotion.
MASH categorizes the level of annoyance caused by noise into five levels: absent, mild, moderate, substantial, and severe.
In our study, every individuals will be given a score of zero to four based on this five levels, higher scores mean a worse outcome.
|
From enrollment to the end of observation at 1 week
|
|
The impact of noise on the work of medical personnel
Time Frame: From enrollment to the end of observation at 1 week
|
Based on our preliminary research findings, we have made a questionnaire titled "Working Conditions in Noisy Environments", which indicates that the impact of noise in the post anesthesia care unit on the work of medical personnel is usually as follows: no impact, failure to hear patient calls or needs in a timely manner, inability to identify alarms from specific medical equipment, need to speak loudly, and throat discomfort.
|
From enrollment to the end of observation at 1 week
|
|
The source of noise as perceived by the medical staff
Time Frame: From enrollment to the end of observation at 1 week
|
Based on our preliminary research findings, we have made a questionnaire titled "Noise source in Post Anesthesia Care Unit", which includes monitor, sputum suction device, ventilator, conversation, mobile phone, printer, outdoor factors (such as the move of transfer beds.), and other.
|
From enrollment to the end of observation at 1 week
|
|
Satisfaction of medical staff with the current noise situation
Time Frame: From enrollment to the end of observation at 1 week
|
Based on our preliminary research findings, we have made a questionnaire titled "Satisfaction with the Current Noise Situation in the Post Anesthesia Care Unit", which includes very satisfied, satisfied, general,dissatisfied, and very dissatisfied.
|
From enrollment to the end of observation at 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 13, 2024
First Posted (Actual)
December 18, 2024
Study Record Updates
Last Update Posted (Actual)
May 31, 2025
Last Update Submitted That Met QC Criteria
May 29, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-214-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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