Clinical trial NCT05785130: The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit.
Official title: The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: sleep quality
sleep disturbance
intensive care unit
critically ill patient
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2023-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline, 1st days, 3rd days and 5th days.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ya-Ching Nien
role: PRINCIPAL_INVESTIGATOR
References: