Trial Outcomes & Findings for The Effects of White Noise for Adult Patients' Sleep Quality in Intensive Care Unit. (NCT NCT05785130)
NCT ID: NCT05785130
Last Updated: 2025-03-17
Results Overview
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.
COMPLETED
NA
60 participants
Baseline, 1st days, 3rd days and 5th days.
2025-03-17
Participant Flow
Participants were recruited at in a medical center at southern Taiwan from March 2023 to August 2024.
Of 60 enrolled participants, 60 meets inclusion criteria and were randomized to white noise or conventional treatment group
Participant milestones
| Measure |
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.
|
Conventional Treatment Group
Treatment as usual without white noise intervention
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Conventional Treatment Group
Treatment as usual without white noise intervention
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
White Noise Group
n=29 Participants
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.
|
Conventional Treatment Group
n=29 Participants
Treatment as usual. without white nose intervention.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.76 years
STANDARD_DEVIATION 11.07 • n=29 Participants
|
59.69 years
STANDARD_DEVIATION 15.74 • n=29 Participants
|
61.72 years
STANDARD_DEVIATION 13.24 • n=58 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=29 Participants
|
10 Participants
n=29 Participants
|
25 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=29 Participants
|
19 Participants
n=29 Participants
|
33 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
APACHE II
|
20.41 units on a scale
STANDARD_DEVIATION 4.05 • n=29 Participants
|
21.48 units on a scale
STANDARD_DEVIATION 5.77 • n=29 Participants
|
20.95 units on a scale
STANDARD_DEVIATION 4.97 • n=58 Participants
|
|
comorbidity
|
1.66 number of comorbidities
STANDARD_DEVIATION 0.94 • n=29 Participants
|
1.59 number of comorbidities
STANDARD_DEVIATION 1.30 • n=29 Participants
|
1.62 number of comorbidities
STANDARD_DEVIATION 1.12 • n=58 Participants
|
|
Critical Care Pain Observation Tool(CPOT)
|
0.45 scores on a scale
STANDARD_DEVIATION 0.87 • n=29 Participants
|
0.83 scores on a scale
STANDARD_DEVIATION 1.20 • n=29 Participants
|
0.64 scores on a scale
STANDARD_DEVIATION 1.05 • n=58 Participants
|
|
Education years
|
10.62 years
STANDARD_DEVIATION 3.24 • n=29 Participants
|
10.72 years
STANDARD_DEVIATION 3.28 • n=29 Participants
|
10.67 years
STANDARD_DEVIATION 3.24 • n=58 Participants
|
|
Use painkiller
Yes
|
9 Participants
n=29 Participants
|
12 Participants
n=29 Participants
|
21 Participants
n=58 Participants
|
|
Use painkiller
No
|
20 Participants
n=29 Participants
|
17 Participants
n=29 Participants
|
37 Participants
n=58 Participants
|
|
Use hypnotic
Yes
|
3 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=58 Participants
|
|
Use hypnotic
No
|
26 Participants
n=29 Participants
|
28 Participants
n=29 Participants
|
54 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
White Noise Group
n=29 Participants
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.
|
Conventional Treatment Group
n=29 Participants
Treatment as usual without white noise intervention.
|
|---|---|---|
|
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
|
898.45 score on a scale
Standard Deviation 312.80
|
|
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
|
746.91 score on a scale
Standard Deviation 323.38
|
|
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
|
665.91 score on a scale
Standard Deviation 300.58
|
|
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
|
559.99 score on a scale
Standard Deviation 268.25
|
Adverse Events
White Noise Group
Conventional Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place