Table 2 Outcomes
intervention | control | p-value | |
|---|---|---|---|
“Please indicate how much you have felt impaired by side effects” (main outcome) (1 “not at all” – 10 “very much”) | 1.5 (±1.4) | 2.8 (±3.0) | p = 0.06 |
“How well did you sleep last night?” (1 “very bad” – 5 “very good”) | 2.4 (±1.3) | 2.1 (±1.2) | p = 0.56 |
“How much did the new drug cause side effects?” (1 “not at all” – 5 “a lot”) | 1.3 (±0.7) | 1.6 (±1.2) | p = 0.23 |
“How satisfied have you been with the new drug?” (1 “not satisfied at all” – 5 “very satisfied”) | 2.0 (±1.3) | 1.6 (±0.8) | p = 0.29 |
“How satisfied have you been with the amount of information about the new drug?” (1 “not satisfied at all” – 5 “very satisfied”) | 4.5 (±1.1) | 4.4 (±1.3) | p = 0.76 |
“How recreative was your sleep?” (1 “very recreative” – 6 “not recreative at all”) | 4.2 (±1.7) | 4.2 (±1.5) | p = 0.98 |
Time to fall asleep (min) | 98.9 (±88.9) | 108.0 (±87.4) | p = 0.55 |
Time spent awake during night (min) | 115.9 (±113.2) | 120.2 (±134.3) | p = 0.90 |
Time spent sleeping (min) | 306.2 (±122.1) | 335.0 (±157.0) | p = 0.47 |
Nightmares (Yes) | 15.4% (n = 4) | 16.0% (n = 4) | p = 1.00 |