SurgeryNCT03504553
The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
A study testing Noise reduction in people with Surgery and 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 on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic… Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Surgery, Noise Exposure
- What is being tested?
- Noise reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 12 Aug 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes.
- Receiving midazolam prior to the procedure as part of standard of care.
Who cannot join
- Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs.
- Allergy to midazolam.
- History of emergence delirium.
- Cardiac disease, other than functional heart murmurs.
- Developmental delays.
- Parent refusal of midazolam for standard clinical care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This project will investigate whether reduction in ambient light and elimination of noise on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.
- Conditions
- Surgery, Noise Exposure
- Being tested
- Noise reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise reductionOther
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.
| 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: Noise reduction |
| Control | No intervention | Normal operating room environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety during induction
A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the mYPAS scale.
Measured: First 5 minutes of surgical procedure
Secondary outcomes (6)
Compliance during induction
A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the ICC scale.
Measured: First 5 minutes of surgical procedure
Presence of post anesthesia emergence delirium
Following transfer to the post anesthesia care unit (PACU) from the OR, the PAED scale will be measured every 10 minutes from arrival until discharge from PACU.
Measured: Average of 30 mins - 1 hr
Post-discharge behavior disturbances
Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.
Measured: Post-op day 1
Post-discharge behavior disturbances
Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.
Measured: Post-op day 2
Post-discharge behavior disturbances
Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.
Measured: Post-op day 7
Noise exposure
Assess the peak and cumulative level of noise exposure to the patient during the entire surgery.
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 posted20 Apr 2018
- Study start18 Oct 2018
- Primary completion12 Aug 2021
- Study completion12 Aug 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 SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT03504553
- Sponsor's protocol ID
- IRB18-00203
- Status last verified
- Jan 2024
- First submitted
- 12 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 Induction and Emergence Behavior in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03504553
- Acronym / sponsor ID
- IRB18-00203
- Conditions
- Surgery, Noise Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Joshua UffmanUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 20 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 on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noise reduction | Experimental | Other: Noise reductionReduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia. |
| Control | No intervention | –Normal operating room environment. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes.
- Receiving midazolam prior to the procedure as part of standard of care.
Key exclusion criteria (6 listed)
- Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs.
- Allergy to midazolam.
- History of emergence delirium.
- Cardiac disease, other than functional heart murmurs.
- Developmental delays.
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 reductionAll 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 |
Primary outcome
Anxiety during induction
Time frame: First 5 minutes of surgical procedure
A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the mYPAS scale.
6 secondary outcomes
Compliance during induction
Time frame: First 5 minutes of surgical procedure
Presence of post anesthesia emergence delirium
Time frame: Average of 30 mins - 1 hr
Post-discharge behavior disturbances
Time frame: Post-op day 1
Post-discharge behavior disturbances
Time frame: Post-op day 2
Post-discharge behavior disturbances
Time frame: Post-op day 7
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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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 Noise reduction in people with Surgery and 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 2 inclusion and 6 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?
Anxiety during induction (time frame: First 5 minutes of surgical procedure). 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 NCT03504553, 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.