Noise LevelsNCT02651129
BC Women's Hospital Noise Pilot
An observational study of Noise Levels, run by University of British Columbia at 1 site in Canada.
Trial summary
The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Noise Levels
- What is being tested?
- Noise measurement
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Operating room staff
Who may be able to join
- BCW staff members
- Presence in OR during Cesarean section
- Willing to have a personal dosimeter pinned to hospital scrubs lapel
Who cannot join
- unable to read and understand English for the purpose of informed consent and perioperative communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Noise in BC Women's Hospital Operating Rooms
The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete their tasks in a safe manner.
This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.
Read the detailed description
This is a pilot study that aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.
The investigators want to quantify the amount of noise in BCW ORs in order to create a research question for a larger study.
- Conditions
- Noise Levels
- Being tested
- Noise measurement
- Keywords
- noise, obstetric, operating rooms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise measurementOther
We will be measuring noise levels in the operating room
What is being measured
The primary outcome is the main question the study is designed to answer.
noise levels in decibels (dBs)
during cesarean section
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise LevelsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia School of Population and Public Health
- Responsible party
- Sponsor
- Investigators
- Vit Gubka, MD FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651129
- Sponsor's protocol ID
- H15-03259
- Status last verified
- Nov 2016
- First submitted
- 18 Dec 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Noise in BC Women's Hospital Operating Rooms
- ClinicalTrials.gov ID
- NCT02651129
- Acronym / sponsor ID
- H15-03259
- Conditions
- Noise Levels
- Keywords
- noise, obstetric, operating rooms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of British Columbia School of Population and Public Health
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete their tasks in a safe manner.
This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.
Detailed description
This is a pilot study that aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.
The investigators want to quantify the amount of noise in BCW ORs in order to create a research question for a larger study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Operating room staff
Key inclusion criteria (3 listed)
- BCW staff members
- Presence in OR during Cesarean section
- Willing to have a personal dosimeter pinned to hospital scrubs lapel
Key exclusion criteria (1 listed)
- unable to read and understand English for the purpose of informed consent and perioperative communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noise measurementWe will be measuring noise levels in the operating room | Other | – |
Primary outcome
noise levels in decibels (dBs)
Time frame: 1.5 hours
during cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
Related trials for Noise Levels
Not yet recruiting
Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy
Procedural Anxiety, Physiological Stress
Recruiting
Spatial Cues, Task Demands, and Auditory Selective Attention
Bilateral Cochlear Implants, Hearing Loss, Bilateral
Not yet recruitingObservational study
Effect of High-Level Headphone Sound Exposure on Exercise Responses in Young Healthy Individuals
Sound Exposure, Exercise Performance
Enrolling by invitation
Comparison of the Effects of Music and White Noise in Children Performed Endoscopy
School Age Children, Endoscopy, Gastrointestinal
Not yet recruitingObservational study
The Study is About the influence of the Combination of Music and Noise Cancelling as a Non-pharmacological Aid in Reducing Anxiety and Discomfort During Wisdom Tooth Removal. The Level of Fear is Measured by a Questionnaire Which the Patients Answer Twice and a Measurement of the Heartbeat
Fear Anxiety, Wisdom Tooth Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vit Gubka, MD FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Levels, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
noise levels in decibels (dBs) (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.