Study period | ||||||
---|---|---|---|---|---|---|
Enrolment | Baseline | Treatment phase | Follow-up phase | |||
Timepointa | –1 week | 0 weeks | 4 weeks | 8 weeks | 4 weeks | 12 weeks |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Medical history | X | |||||
Allocation | X | |||||
Interventions | ||||||
Acupuncture | X | X | X | |||
Sham acupuncture | X | X | X | |||
Assessments | ||||||
Primary outcome | ||||||
PSQI | X | X | X | X | X | |
Secondary outcomes | ||||||
ISI | X | X | ||||
Actigraphy | X | X | ||||
SDS | X | X | ||||
SAS | X | X | ||||
Men-QoL | X | X | X | X | X | |
Others | ||||||
Estazolam dose | X | X | X | X | X | |
Adverse events | X | X | X | X | X | |
Patients’ satisfaction | X | |||||
Success of blinding | X |