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NCT Number: NCT05785130

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

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 white 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 white noise can improve sleep quality in adult ICU patients compared with conventional treatment group.

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Key information

Conditions

Sleep Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

About this study

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 white noise intervention in sleep quality in adult intensive care unit patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

White Noise

Other

Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50.

Primary outcomes

  1. The Verran and Snyder-Halpern Sleep Scale Scores on Baseline, the First Intervention Day(T1), the Third Intervention Day(T2), and Follow up Two Days Later After Intervention (T3) Between Two Groups.

    Time frame: Baseline, 1st days, 3rd days and 5th days.

    Sleep quality is assessed using the Verran and Snyder-Halpern (VSH) Sleep Scale, a subjective sleep scale that contains three dimensions: sleep disturbance, sleep effectiveness, and sleep supplementation, with a total of 15 items. Scores are measured using a visual analogue scale, which is a 100mm horizontal line. The maximum score is 100, and the minimum score is 0. The total score of the VSH Sleep Scale (VSHSS) ranges from 0 to 1500. The subscales are combined by summing the individual scores for each item, and the total score is obtained by adding the scores from each of the subscales. The lower the score, the poorer the sleep quality. Outcomes were measured at baseline, the first intervention day (T1), the third intervention day (T2), and two days after the intervention (T3) for both groups.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Kaohsiung Medical University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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