The Effects of Background Noise for Adult Patients' Sleep Quality in Intensive Care Unit.

February 6, 2024 updated by: Ya-Ching, Nien, Chang Gung Memorial Hospital

The Effects of Background Noise for Adult Patients' Sleep Quality in Intensive Care Unit: a Randomized Controlled Trial

Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). The causes of sleep disturbance are complicated. Poor sleep quality can lead to negative consequences for patients' physical and mental health. Non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. This study is a randomized controlled trial that compared two parallel patient groups.The hypothesis of this study is that background noise can improve sleep quality in adult ICU patients compared with conventional treatment group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Poor sleep quality is one of the most common problems among adult patients in the intensive care unit (ICU). Statistics indicate that over 50% of ICU patients report sleep abnormalities, such as sleep fragmentation, arousals, frequent awakenings, and poor sleep quality. The causes of sleep disturbance are complicated, with evidence suggesting that environmental factors such as noise, from alarms and machines that are active around the clock in the ICU, play a significant role. Poor sleep quality can lead to negative consequences for patients' physical and mental health.

Sleep promotion interventions, including both pharmacological and non-pharmacological approaches, have been proposed. However, the side effects of pharmacological intervention may also lead to poor outcomes. Therefore, non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality.

This study was conducted in randomized controlled trial that compared two parallel patient groups. Patients were included by convenience sampling in a medical center in Taiwan. The Verran and Snyder-Halpern Sleep Scale (VSHSS) was used to assess subjective sleep quality. The main purpose of this study was to investigate the effect of background noise intervention in sleep quality in adult intensive care unit patients.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung city, Taiwan, 833401
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Ya-Ching Nien
        • Sub-Investigator:
          • Pi-Ling Chou, PhD
        • Sub-Investigator:
          • Kuo-Tung Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age must be greater than or equal to 20 years old.
  • Admitted to the ICU and have been intubated for at least 24 hours.
  • Aware of people, time, and place, and without hearing impairment.
  • Be able to communicate in writing.
  • The Glasgow Coma Scale score must be equal to or greater than 11, with a vocal response of 1 in the patient post-endotracheal tube placement.

Exclusion Criteria:

  • History of insomnia, Alzheimer's disease, or depression.
  • Routine use of sedative-hypnotic drugs (opioids, benzodiazepines, non-benzodiazepines, antihistamines, and melatonin) before admission.
  • Post-operation in the operating room before ICU admission.
  • ICDSC score of at least 4 or CAM-ICU positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: background noise group
Background noise at bedtime.
Other: background noise
Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50.
No Intervention: conventional treatment group
Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Verran and Snyder-Halpern Sleep Scale scores changed from baseline to 1st days, 3rd days and 5th days.
Time Frame: Baseline, 1st days, 3rd days and 5th days.
Sleep quality is accessed by using Verran and Snyder-Halpern(VSH) Sleep Scale, a subjective sleep scale contains three dimensions: sleep disturbance, sleep effectiveness and sleep supplementation with totally 15 items. Scores were measured by using visual analogue scale which is a 100mm horizontal lines. The maxium score is 100 and the minimum score is 0. Totally score of VSHSS range from 0 to 1500. The lower of the score, the poorer of the sleep quality.
Baseline, 1st days, 3rd days and 5th days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Kaohsiung Medical University

Investigators

  • Principal Investigator: Ya-Ching Nien, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202300153B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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