Period week(W) | Enrollment | Allocation | Treatment | Follow-up | |||
---|---|---|---|---|---|---|---|
Week − 1 | Week 0 | Week 1 | Week 4 | Week 8 | Week 12 | Week 20 | |
Enrollment | × | ||||||
Informed consent | × | ||||||
Medical history | × | ||||||
Merger disease | × | ||||||
Randomization | × | ||||||
Intervention | × | × | × | ||||
Primary outcome | |||||||
PSQI | × | × | × | × | × | × | |
Secondary outcomes | |||||||
Actigraphy | × | × | |||||
QLQ-C30 | × | × | |||||
PHQ-9 | × | × | |||||
Dose of hypnotics | × | × | × | × | × | × | |
Adverse event monitoring (side effects and complications) | × | × | × | × | × | × | × |
Assessment of credibility | × | ||||||
Assessment of blinding success | × | × |