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

NCT05785130 | Completed Results

• 1 other identifier: 202300153B0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Keywords

sleep quality; sleep disturbance; intensive care unit; critically ill patient

Outcome Measures

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.

  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.

  Baseline, 1st days, 3rd days and 5th days.

Study Arms (2)

white noise group

EXPERIMENTAL

Background noise at bedtime.

Other: white noise

conventional treatment group

NO INTERVENTION

Treatment as usual.

Interventions

white noise OTHER

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

white noise group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Kaohsiung Medical University: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Ya-Ching, Nien
• Organization: ChangGung Memorial Hospital

yaching79@cgmh.org.tw

+886 913112012

Study Officials

• Ya-Ching Nien

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: April 17, 2023
• Primary Completion: August 4, 2024
• Study Completion: November 28, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)