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The sample size was calculated based on our pilot study, which found that the estimated standard deviation of mean sleep score in ICU patients was 27.
We hypothesized that the non-pharmacological intervention could improve the sleep quality by inducing a 28-point difference of total mean sleep score between groups.
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Changes in the sleep problems index score were highly statistically different from 0 for all the groups of improved ('very much', 'much' and 'minimally') patients based on the mean sleep interference score, the pain score, and the clinician and patient global impression of change (p < 0.0001) (Table 5).
Note: * p < 0.05; **p < 0.0001 The change in score on the sleep problems index was evaluated according to change in mean sleep interference score, change in mean pain score, CGIC and PGIC between V2 and V6 (Table 5).
The weekly mean sleep interference score and the weekly mean pain score at baseline were used to define groups of patients differing in severity.
Self-reported FM severity was moderate/severe in 86.0% of patients; mean current pain score was 6.40 ± 2.19 (moderate), and mean sleep interference score was 7.28 ± 2.23 (severe).
Stable patients, as defined by no change in the mean sleep interference score or no change in the mean pain score, also showed a significant (but lower than for the 'improved' group) change in MOS sleep problems index score (p = 0.0005 and 0.0003, respectively), whereas stable patients as defined by the CGIC and the PGIC showed no statistically significant change in MOS sleep problems index score.
Changes in the sleep problems index score of the 'worsened' patients defined on the mean sleep interference score, the CGIC and the PGIC were not statistically different from 0 (Table 5).
Baseline mean pain scores and mean sleep interference scores were comparable among age and dosage groups.
Figure 1 displays the mean scores of the MOS-Sleep dimensions for each severity group as defined with the mean sleep interference score at baseline.
The mean sleep disturbance score was 26.7 ± 9.9.
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