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Table 2 Schedule for treatment and outcome assessment

From: Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Visit

Screening

1

2–5

6

7–10

11

12

13

Week

 

1

1–2

3

3–4

5

9

13

Informed consent

●

       

Inclusion/exclusion criteria

●

       

Treatment expectation questionnaire

●

       

Vital signs

●

●

○

●

○

●

●

●

Demographic characteristics

●

       

Medical history

●

       

Laboratory tests

●

    

●

  

Random allocation

 

●

      

Change of medical history

 

●

○

●

○

●

●

●

EA treatment

 

○

○

○

○

   

ISI

●

●

 

●

 

●

●

●

Melatonin/cortisol study

 

●

   

●

  

PSQI

 

●

 

●

 

●

●

●

Sleep diary

●

●

 

●

 

●

●

●

HADS

●

●

 

●

 

●

●

●

EQ-5D

 

●

 

●

 

●

●

●

PGIC

   

●

 

●

●

●

Blinding test

 

○

  

○

   

Safety assessment

 

●

○

●

○

●

●

●

  1. ●, All groups; ○, treatment groups
  2. EA electroacupuncture, EQ-5D EuroQoL five dimension questionnaire, HADS Hospital Anxiety and Depression Scale, ISI Insomnia Severity Index, PGIC Patient Global Impression of Change, PSQI Pittsburgh Sleep Quality Index
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