Noise ExposureNOISYNCT04643652
Effective Strategies to Reduce Noise and Related Distractions
A study testing Noise Reduction Bundle in people with Noise Exposure and Intensive Care Unit, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noise Exposure, Intensive Care Unit, Safety Issues
- What is being tested?
- Noise Reduction Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2022to 1 Sep 2023
- 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
- Healthcare providers present during the study period (about 250) are asked to participate between august 2022 and december 2023.
Who cannot join
- Healthcare providers who do not speak / read the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Strategies to Reduce Noise and Noise Related Distractions in the ICU : a Stepped Wedge Cluster Randomized Controlled Trial
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels. In addition, many medical and nursing ICU staff members work together with numerous visiting consultants resulting in an additional sound burden. As is already known, in the ICU environment, many activities carried out by healthcare professionals, require a high level of concentration. So, the noisy ICU environment causes interruptions in activities that require concentration and induce in this way, a higher potential for errors. The World Health Organization (WHO) and the Environmental Protection Agency (EPA) set standards for sound levels in hospitals with a recommendation for patient treatment areas. There is a clear trend for increasing hospital noise since the sixties. According to healthcare professionals, one of the strongest contributing factors of noise in the ICU environment are monitoring alarms as they occur very frequently. Additionally, ICU nurses experience high levels of stress towards clinical alarms and are becoming alarm fatigue, which means that the staff becomes desensitized because of an excessive number of alarms and may disable or silence alarms without checking the patient . Consensus dictates the importance of reducing sound pressure levels and the numerous alarm signals from monitor alarms in the ICU. In the study, we focus on busy predetermined areas in the ICU.
This study aims to determine the effect of an intervention bundle, aimed at the reduction of "noise" (decibels) and its effect on health care professionals.
Read the detailed description
Design:
The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in five units of the department of intensive care medicine of the Radboud University Medical Center, a 950-bed university hospital in the Netherlands. The study focus on health care providers in the ICU.The research consists of the introduction of an intervention bundle to reduce noise and therefore interruptions during their daily work activities.
Inclusion:
All health care providers present at the ICU, during the study period (about 350) are asked to participate. They will receive information about the aim, content and relevance of the study and will be asked for participation.They are free to refuse to participate in the study (e.g. part of observations, survey).
Methods:
The data collection focuses on quantitative noise measurements at the predetermined locations in ICU units during the study period. In addition, during the entire study period (control and intervention), we analyse the amount and type of alarms. Thirdly, we collect data with regard to disruptions during the daily work process of healthcare professionals (e.g. during "high-risk moments", such as: medication preparation) by observations.
Finally, health care providers are asked about their perceived annoyance, as a result of ambient noise (NRS-annoyance).
Data analysis will be supported with the use of Excel, Phyton and SPSS.
- Conditions
- Noise Exposure, Intensive Care Unit, Safety Issues
- Being tested
- Noise Reduction Bundle
- Keywords
- Noise, ICU, Alarms, Annoyance, Distractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise Reduction BundleBehavioural
Implementation of a bundle of noise reducing interventions. This concerns among other things:
reduction of alarms, phone calls/pagers/ beepers, introduction of a defined period in which there is a reduction of controllable sound (quiet time), etc
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| Intervention | Experimental | Implementation of a Noise Reduction Bundle Receives: Behavioral: Noise Reduction Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound pressure levels
Sound pressure levels at predetermined locations
Measured: through study completion, an average of 1 year
Acoustic alarms
e.g. acoustic alarms (ventilation, heartrate, tension, etc )
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Interruptions
e.g. number of interruptions during daily work (count)
Measured: through study completion, an average of 1 year
Annoyance (as an emotional impact on health care providers)
e.g. perceived annoyance caused by alarms, telephones, pagers, conversation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jul 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Stepped Wedge Cluster Randomised Model
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans vd Hoeven, MD, PhD, Principal investigator, Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643652
- Sponsor's protocol ID
- 2019-5541
- Acronym
- NOISY
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2020
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Strategies to Reduce Noise and Noise Related Distractions in the ICU : a Stepped Wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04643652
- Acronym / sponsor ID
- NOISY / 2019-5541
- Conditions
- Noise Exposure, Intensive Care Unit, Safety Issues
- Keywords
- Noise, ICU, Alarms, Annoyance, Distractions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Nov 2020 (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.
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels. In addition, many medical and nursing ICU staff members work together with numerous visiting consultants resulting in an additional sound burden. As is already known, in the ICU environment, many activities carried out by healthcare professionals, require a high level of concentration. So, the noisy ICU environment causes interruptions in activities that require concentration and induce in this way, a higher potential for errors. The World Health Organization (WHO) and the Environmental Protection Agency (EPA) set standards for sound levels in hospitals with a recommendation for patient treatment areas. There is a clear trend for increasing hospital noise since the sixties. According to healthcare professionals, one of the strongest contributing factors of noise in the ICU environment are monitoring alarms as they occur very frequently. Additionally, ICU nurses experience high levels of stress towards clinical alarms and are becoming alarm fatigue, which means that the staff becomes desensitized because of an excessive number of alarms and may disable or silence alarms without checking the patient . Consensus dictates the importance of reducing sound pressure levels and the numerous alarm signals from monitor alarms in the ICU. In the study, we focus on busy predetermined areas in the ICU.
This study aims to determine the effect of an intervention bundle, aimed at the reduction of "noise" (decibels) and its effect on health care professionals.
Detailed description
Design:
The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in five units of the department of intensive care medicine of the Radboud University Medical Center, a 950-bed university hospital in the Netherlands. The study focus on health care providers in the ICU.The research consists of the introduction of an intervention bundle to reduce noise and therefore interruptions during their daily work activities.
Inclusion:
All health care providers present at the ICU, during the study period (about 350) are asked to participate. They will receive information about the aim, content and relevance of the study and will be asked for participation.They are free to refuse to participate in the study (e.g. part of observations, survey).
Methods:
The data collection focuses on quantitative noise measurements at the predetermined locations in ICU units during the study period. In addition, during the entire study period (control and intervention), we analyse the amount and type of alarms. Thirdly, we collect data with regard to disruptions during the daily work process of healthcare professionals (e.g. during "high-risk moments", such as: medication preparation) by observations.
Finally, health care providers are asked about their perceived annoyance, as a result of ambient noise (NRS-annoyance).
Data analysis will be supported with the use of Excel, Phyton and SPSS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomised Model
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| Intervention | Experimental | Behavioral: Noise Reduction BundleImplementation of a Noise Reduction Bundle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers present during the study period (about 250) are asked to participate between august 2022 and december 2023.
Key exclusion criteria (1 listed)
- Healthcare providers who do not speak / read the Dutch language
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 Reduction BundleImplementation of a bundle of noise reducing interventions. This concerns among other things: reduction of alarms, phone calls/pagers/ beepers, introduction of a defined period in which there is a reduction of controllable sound (quiet time), etc | Behavioural | Intervention |
Primary outcome
Sound pressure levels
Time frame: through study completion, an average of 1 year
Sound pressure levels at predetermined locations
Acoustic alarms
Time frame: through study completion, an average of 1 year
e.g. acoustic alarms (ventilation, heartrate, tension, etc )
2 secondary outcomes
Interruptions
Time frame: through study completion, an average of 1 year
Annoyance (as an emotional impact on health care providers)
Time frame: through study completion, an average of 1 year
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 12 Aug 2024.
- 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.
Hans vd Hoeven, MD, PhD principal investigator
Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands
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 Bundle in people with Noise Exposure and Intensive Care Unit, run by Radboud University Medical Center at 1 site in Netherlands.
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 12 Aug 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 Netherlands. 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?
Sound pressure levels (time frame: through study completion, an average of 1 year). 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 12 Aug 2024.