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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785130
• Other study ID #: 202300153B0
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Ya-Ching Nien
• Phone: +886-7-7317123
• Email: yaching79[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung city

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Verran and Snyder-Halpern Sleep Scale scores changed from baseline to 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.