Noise; Adverse EffectNCT05636488
Determination of the Effects of Noise Level in the Operating Room
An observational study of Noise; Adverse Effect and Noise Induced Hearing Loss, run by Baskent University.
Trial summary
The goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise; Adverse Effect, Noise Induced Hearing Loss
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 18 without hearing loss who will undergo elective surgery under general anesthesia
Who may be able to join
- patients over the age of 18,
- Elective cases to be taken under general anesthesia,
- Those who do not have a psychiatric disease,
- Patients without hearing loss
Who cannot join
- patients under the age of 18
- Patients who have psychiatric disease
- Patients who has hearing loss
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determination of the Effects of Noise Level in the Operating Room on the Anesthesiologist, Patient, and Environment During the Induction Phase and Investigation of the Effect of Staff Training
The goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery.
Read the detailed description
There are many factors that can negatively affect surgical performance in operating rooms. Noise is the most striking of these factors. Excessive noise can cause hearing loss, cognitive dysfunction, anxiety, stress-induced increases in cortisol levels, and an increased risk of cardiovascular disease. Noise can have negative effects on concentration and performance. At the same time, workplace noise is one of the most important causes of fatigue. One of the anesthesia phases where the sound level reaches the highest levels is the induction phase. With this study, the investigators want to examine the effects on the anesthesia team, the patient and the environment by measuring the noise levels during the induction period, and then train the operating room personnel to examine the effects on this issue. The investigators aim to raise awareness about the development of procedures and training programs for operating room personnel.
- Conditions
- Noise; Adverse Effect, Noise Induced Hearing Loss
- Being tested
- No intervention
- Keywords
- noise induced hearing loss, operatin room's noise
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention group in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing effect of noise level on fatigue with questionnaire
A quieter environment can be created if noise level can be shown to cause fatigue in work performance.
Measured: postoperative 24 hours
assessing effect of noise level on anxiety with questionnaire
A quieter environment can be created if noise level can be shown to cause anxiety in work performance.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise; Adverse EffectStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Nemika Gökdemir, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636488
- Sponsor's protocol ID
- 2022-07/1932
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects of Noise Level in the Operating Room on the Anesthesiologist, Patient, and Environment During the Induction Phase and Investigation of the Effect of Staff Training
- ClinicalTrials.gov ID
- NCT05636488
- Acronym / sponsor ID
- 2022-07/1932
- Conditions
- Noise; Adverse Effect, Noise Induced Hearing Loss
- Keywords
- noise induced hearing loss, operatin room's noise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- 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 goal of this observational study is to learn about effects of noise in healthy patients undergoing elective surgery.
Detailed description
There are many factors that can negatively affect surgical performance in operating rooms. Noise is the most striking of these factors. Excessive noise can cause hearing loss, cognitive dysfunction, anxiety, stress-induced increases in cortisol levels, and an increased risk of cardiovascular disease. Noise can have negative effects on concentration and performance. At the same time, workplace noise is one of the most important causes of fatigue. One of the anesthesia phases where the sound level reaches the highest levels is the induction phase. With this study, the investigators want to examine the effects on the anesthesia team, the patient and the environment by measuring the noise levels during the induction period, and then train the operating room personnel to examine the effects on this issue. The investigators aim to raise awareness about the development of procedures and training programs for operating room personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 without hearing loss who will undergo elective surgery under general anesthesia
Key inclusion criteria (4 listed)
- patients over the age of 18,
Key exclusion criteria (3 listed)
- patients under the age of 18
- Patients who have psychiatric disease
- Patients who has hearing loss
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 |
|---|---|---|
| No interventionThere is no intervention group in this study | Other | – |
Primary outcome
assessing effect of noise level on fatigue with questionnaire
Time frame: postoperative 24 hours
A quieter environment can be created if noise level can be shown to cause fatigue in work performance.
assessing effect of noise level on anxiety with questionnaire
Time frame: postoperative 24 hours
A quieter environment can be created if noise level can be shown to cause anxiety in work performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise; Adverse Effect and Noise Induced Hearing Loss, run by Baskent University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begüm Ne Gökdemir (+905389598290, begokdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing effect of noise level on fatigue with questionnaire (time frame: postoperative 24 hours). The study lists 2 primary outcomes in all. 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 5 Dec 2022.