Sleep
Conditions
Keywords
sleep quality, sleep disturbance, intensive care unit, critically ill patient
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.
Interventions
OTHERwhite noise
Using sound machine for 3 days at bedtime for 7 hours(11p.m.- 6a.m.) in a decibel of 40-50.
Sponsors
Kaohsiung Medical University
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline, 1st days, 3rd days and 5th days. | 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. |
Countries
Taiwan
Participant flow
Recruitment details
Participants were recruited at in a medical center at southern Taiwan from March 2023 to August 2024.
Pre-assignment details
Of 60 enrolled participants, 60 meets inclusion criteria and were randomized to white noise or conventional treatment group
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Conventional Treatment Group Treatment as usual. without white nose intervention. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | White Noise Group | Conventional Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 63.76 years STANDARD_DEVIATION 11.07 | 59.69 years STANDARD_DEVIATION 15.74 | 61.72 years STANDARD_DEVIATION 13.24 |
| APACHE II | 20.41 units on a scale STANDARD_DEVIATION 4.05 | 21.48 units on a scale STANDARD_DEVIATION 5.77 | 20.95 units on a scale STANDARD_DEVIATION 4.97 |
| comorbidity | 1.66 number of comorbidities STANDARD_DEVIATION 0.94 | 1.59 number of comorbidities STANDARD_DEVIATION 1.3 | 1.62 number of comorbidities STANDARD_DEVIATION 1.12 |
| Critical Care Pain Observation Tool(CPOT) | 0.45 scores on a scale STANDARD_DEVIATION 0.87 | 0.83 scores on a scale STANDARD_DEVIATION 1.2 | 0.64 scores on a scale STANDARD_DEVIATION 1.05 |
| Education years | 10.62 years STANDARD_DEVIATION 3.24 | 10.72 years STANDARD_DEVIATION 3.28 | 10.67 years STANDARD_DEVIATION 3.24 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
| Use hypnotic No | 26 Participants | 28 Participants | 54 Participants |
| Use hypnotic Yes | 3 Participants | 1 Participants | 4 Participants |
| Use painkiller No | 20 Participants | 17 Participants | 37 Participants |
| Use painkiller Yes | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
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.
Time frame: Baseline, 1st days, 3rd days and 5th days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| White Noise Group | 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. | baseline(T0) | 873.38 score on a scale | Standard Deviation 262.24 |
| White Noise Group | 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. | the first intervention day(T1) | 880.48 score on a scale | Standard Deviation 226.89 |
| White Noise Group | 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. | the third intervention day (T2) | 901.84 score on a scale | Standard Deviation 259.23 |
| White Noise Group | 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. | two days after the intervention (T3) | 774.17 score on a scale | Standard Deviation 277.87 |
| Conventional Treatment Group | 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. | two days after the intervention (T3) | 559.99 score on a scale | Standard Deviation 268.25 |
| Conventional Treatment Group | 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. | baseline(T0) | 898.45 score on a scale | Standard Deviation 312.8 |
| Conventional Treatment Group | 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. | the third intervention day (T2) | 665.91 score on a scale | Standard Deviation 300.58 |
| Conventional Treatment Group | 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. | the first intervention day(T1) | 746.91 score on a scale | Standard Deviation 323.38 |
Comparison: It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.p-value: 0.74t-test, 2 sided
Comparison: It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.p-value: 0.75t-test, 2 sided
Comparison: It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.p-value: <0.01t-test, 2 sided
Comparison: It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.p-value: <0.01t-test, 2 sided