Period | Screening | Treatment | Follow-up | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
Week | 1~4 | 5 | 13 | ||||||||||
Informed consent | • | ||||||||||||
Demographic characteristics | • | ||||||||||||
Medical history | • | ||||||||||||
Laboratory test, chest X-ray, electrocardiogram, pregnancy test | • | ||||||||||||
Inclusion/exclusion criteria | • | ||||||||||||
Numeric rating scale | • | ○ | • | • | |||||||||
Vital signs | • | • | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | • | • |
Change of medical history | • | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | • | • | |
Random allocation | • | ||||||||||||
Treatment expectancy questionnaire | • | ||||||||||||
Chronic fatigue syndrome questionnaire | • | ||||||||||||
Fatigue Severity Scale | • | ○ | • | • | |||||||||
A short form of Stress Response Inventory | • | ○ | • | • | |||||||||
Beck Depression Inventory | • | ○ | • | • | |||||||||
EuroQol-5 Dimension | • | ○ | • | • | |||||||||
Acupuncture treatment | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |||
Safety assessment | • | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | • | • |