N/A
N=60
The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit.
Sleep
Bottom Line
View on ClinicalTrials.gov: NCT05785130 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: 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. — 873.38; 898.45; 880.48; 746.91 score on a scale — p=0.74
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- white noise (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
873.38; 898.45; 880.48; 746.91; 901.84; 665.91 | 0.74 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05785130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.