Effective Strategies to Reduce Noise and Related Distractions

NCT ID: NCT04643652

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-09-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Implementation of a Noise Reduction Bundle

Group Type: EXPERIMENTAL

Noise Reduction Bundle

Intervention Type: 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

Interventions

Noise Reduction Bundle

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans vd Hoeven, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

2019-5541

Identifier Type: -

Identifier Source: org_study_id