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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Sleep

Treatments

Other: white noise

Study type

Interventional

Funder types

Other

Identifiers

NCT05785130
202300153B0

Details and patient eligibility

About

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.

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

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

white noise group
Experimental group
Description:
Background noise at bedtime.
Treatment:
Other: white noise
conventional treatment group
No Intervention group
Description:
Treatment as usual.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ya-Ching Nien

Data sourced from clinicaltrials.gov

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