Noise ExposureNCT03507855
The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider
A study testing Reduced noise and Normal in people with Noise Exposure, run by Joshua Uffman at 1 site in United States.
Trial summary
This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noise Exposure
- What is being tested?
- Reduced noise and Normal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 30 Nov 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anesthesia providers that have agreed to participate.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider to Auditory and Visual Alarms During Induction and Emergence From General Anesthesia
This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.
- Conditions
- Noise Exposure
- Being tested
- Reduced noise, Normal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced noiseOther
All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.
NormalOther
No change in the normal operating room environment.
| Study group | Role | What they receive |
|---|---|---|
| Noise reduction | Experimental | Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia. Receives: Other: Reduced noise |
| Control | Active comparator | Normal operating room environment. Receives: Other: Normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction response time
Response time of the anesthesia provider to the auditory/visual alarm during induction of anesthesia
Measured: Within 5 mins of patient entering the OR
Emergence response time
Response time of the anesthesia provider to the auditory/visual alarm during emergence from anesthesia
Measured: Within 5-15 mins after completion of surgery
Secondary outcomes (1)
Noise exposure
Assess the cumulative level of noise exposure to the anesthesia provider during the entire surgery of a patient
Measured: Average of 30 mins - 3 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start18 Oct 2018
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Uffman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Uffman, Nationwide Children's Hospital
- Investigators
- Richard Cartabuke, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507855
- Sponsor's protocol ID
- IRB18-00227
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bozych M, Tram NK, Rice-Weimer J, Cartabuke RS, Tobias JD, Huffman J, Mpody C, Uffman JC. Operating Room Noise Environment and Behavior in Children Undergoing General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2024 Aug 16;2024:4838649. doi: 10.1155/2024/4838649. eCollection 2024.
PubMed 39185368
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider to Auditory and Visual Alarms During Induction and Emergence From General Anesthesia
- ClinicalTrials.gov ID
- NCT03507855
- Acronym / sponsor ID
- IRB18-00227
- Conditions
- Noise Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Joshua UffmanUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Apr 2018 (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.
This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noise reduction | Experimental | Other: Reduced noiseReduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia. |
| Control | Active comparator | Other: NormalNormal operating room environment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesia providers that have agreed to participate.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Reduced noiseAll activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted. | Other | Noise reduction |
| NormalNo change in the normal operating room environment. | Other | Control |
Primary outcome
Induction response time
Time frame: Within 5 mins of patient entering the OR
Response time of the anesthesia provider to the auditory/visual alarm during induction of anesthesia
Emergence response time
Time frame: Within 5-15 mins after completion of surgery
Response time of the anesthesia provider to the auditory/visual alarm during emergence from anesthesia
1 secondary outcome
Noise exposure
Time frame: Average of 30 mins - 3 hrs
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 8 Jan 2024.
- Derived from this study: PubMed 39185368Bozych M, Tram NK, Rice-Weimer J, Cartabuke RS, Tobias JD, Huffman J, Mpody C, Uffman JC. Operating Room Noise Environment and Behavior in Children Undergoing General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2024 Aug 16;2024:4838649. doi: 10.1155/2024/4838649. eCollection 2024.
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OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
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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.
Richard Cartabuke, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced noise and Normal in people with Noise Exposure, run by Joshua Uffman at 1 site in United States.
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 1 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 8 Jan 2024. 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 United States. 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?
Induction response time (time frame: Within 5 mins of patient entering the OR). 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?
On the ClinicalTrials.gov record for NCT03507855, which also lists 1 linked publication.
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 8 Jan 2024.