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| Name | Class |
|---|---|
| Kaohsiung Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| white noise group | Experimental | Background noise at bedtime. |
|
| conventional treatment group | No Intervention | Treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| white noise | Other | Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ya-Ching Nien | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | 833401 | Taiwan |
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Of 60 enrolled participants, 60 meets inclusion criteria and were randomized to white noise or conventional treatment group
Participants were recruited at in a medical center at southern Taiwan from March 2023 to August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | White Noise Group | white noise at bedtime. white noise: Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. |
| FG001 | Conventional Treatment Group | Treatment as usual without white noise intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | White Noise Group | white noise at bedtime. white noise: Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. |
| BG001 | Conventional Treatment Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1st days, 3rd days and 5th days. |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | White Noise Group | Background noise at bedtime. white noise: Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ya-Ching, Nien | ChangGung Memorial Hospital | +886 913112012 | yaching79@cgmh.org.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2023 | Mar 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Treatment as usual. without white nose intervention.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| APACHE II | The APACHE II (Acute Physiology and Chronic Health Evaluation II) score ranges from 0 to 71. The minimum score: 0 (indicating the least severe condition, with no acute physiological abnormalities or chronic health problems). The maximum score: 71 (indicating the most severe condition, with significant acute physiological abnormalities and severe chronic health problems). | Mean | Standard Deviation | units on a scale |
|
| comorbidity | The comorbility means one or more diseases that exist at the same times in one person. | Mean | Standard Deviation | number of comorbidities |
|
| Critical Care Pain Observation Tool(CPOT) | The Critical Care Pain Observation Tool (CPOT) rates critically ill patients' pain based on clinical observation. The Critical Care Pain Observation Tool (CPOT) includes four observation indicators: facial expression, body movements, muscle tension, and ventilation (for ventilated patients). Each indicator is rated on a scale from 0 to 2 and the total score is obtained by adding the scores from each indicator. The total score of the CPOT range from 0 to 8 with a higher score indicating a higher level of pain. | Mean | Standard Deviation | scores on a scale |
|
| Education years | Mean | Standard Deviation | years |
|
| Use painkiller | Count of Participants | Participants |
|
| Use hypnotic | Count of Participants | Participants |
|
| OG000 |
| White Noise Group |
Background noise at bedtime. white noise: Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50. |
| OG001 | Conventional Treatment Group | Treatment as usual without white noise intervention. |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Conventional Treatment Group | Treatment as usual without whote noise intervention. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D001523 |
| Mental Disorders |