NOISY: Effective Strategies to Reduce Noise and Related Distractions

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04643652
Collaborator
(none)
250
1
2
21.9
11.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Noise Reduction Bundle
N/A

Detailed Description

Design:

The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in seven 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 recieve 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 emotional impact e.g. annoyance, as a result of ambient noise (questionaires). Items in the questionnaires are e.g: degree of annoyance as a result of alarms, conversation, equipment, pagers/telefoons.

Data analysis will be supported with the use of Phyton and MatLab.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Stepped Wedge Cluster Randomised ModelStepped Wedge Cluster Randomised Model
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effective Strategies to Reduce Noise and Noise Related Distractions in the ICU : a Stepped Wedge Cluster Randomized Controlled Trial
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Usual Care

Experimental: Intervention

Implementation of a Noise Reduction Bundle

Behavioral: Noise Reduction Bundle
Implementation of a bundle of noise reducing interventions. This concerns among other things: reduction of alarms, phone calls/pagers/ bleepers, introduction of a defined period in which there is a reduction of controllable sound (quiet time), etc

Outcome Measures

Primary Outcome Measures

  1. Sound pressure levels [through study completion, an everage of 1 year]

    Sound pressure levels at predetermined locations

  2. Acoustic alarms [through study completion, an everage of 1 year]

    e.g. acoustic alarms (ventilation, heartrate, tension, etc )

Secondary Outcome Measures

  1. Interruptions [through study completion, an everage of 1 year]

    e.g. number of interruptions during daily work (count)

  2. Interruptions [through study completion, an everage of 1 year]

    e.g. cause or source (interruption caused by conversation or caused by alarms or telephone calls)

  3. Annoyance (as an emotional impact on health care providers) [through study completion, an everage of 1 year]

    e.g. perceived annoyance caused by alarms, telephones, pagers, conversation

  4. Stress (as an emotional impact on health care providers) [through study completion, an everage of 1 year]

    e.g. perceived stress caused by alarms, telephones, pagers, conversation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

• Healthcare providers present during the study period (about 250) are asked to participate between november 2020 and september 2021.

Exclusion Criteria:

• Healthcare providers who do not speak / read the Dutch language

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radboudumc Nijmegen Gld Netherlands 6500hb

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

  • Principal Investigator: Hans vd Hoeven, MD, PhD, Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT04643652
Other Study ID Numbers:
  • 2019-5541
First Posted:
Nov 25, 2020
Last Update Posted:
Nov 25, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Radboud University Medical Center

Study Results

No Results Posted as of Nov 25, 2020