Effective Strategies to Reduce Noise and Related Distractions

NCT04643652 | Completed

• 1 other identifier: 2019-5541
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Noise Exposure; Intensive Care Unit; Safety Issues

Keywords

Noise; ICU; Alarms; Annoyance; Distractions

Outcome Measures

Primary Outcomes (2)

• Sound pressure levels

  Sound pressure levels at predetermined locations

  through study completion, an average of 1 year

• Acoustic alarms

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

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Interruptions

  through study completion, an average of 1 year

• Annoyance (as an emotional impact on health care providers)

  through study completion, an average of 1 year

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Intervention

EXPERIMENTAL

Implementation of a Noise Reduction Bundle

Behavioral: Noise Reduction Bundle

Interventions

Noise Reduction Bundle BEHAVIORAL

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare providers present during the study period (about 250) are asked to participate between august 2022 and december 2023.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500hb, Netherlands

Location

Study Officials

• Hans vd Hoeven, MD, PhD

  Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped Wedge Cluster Randomised Model

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: November 25, 2020
• Study Start: July 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)