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Table 1 Timing of treatment assessments and data collection

From: Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial

 

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