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Table 3 The schedule of enrollment, intervention, and assessments

From: Influence of the patient-practitioner interaction context on acupuncture outcomes in functional dyspepsia: study protocol for a multicenter randomized controlled trial

Study period

Screening

Visit

Acupuncture treatment period

Visit

 

v1

v2

v3

v4

v5

v6

v7

v8

Week

 

1

1

2

2

3

3

4

4

Patients

         

 Informed Consent

        

 Demographics

        

 Physical examination

        

 History Examination

        

 Dyspepsia History Examination

        

 Inclusion/Exclusion Criteria

        

 Serologic test/ Evaluation

        

 BDI

        

 Randomization

        

Trial evaluation

         

 Investigation of Concomitant medication

 

*

*

*

*

*

*

*

*

 Adverse events

 

*

*

*

*

*

*

*

*

Outcomes

         

 AR of abdominal pain & discomfort

  

*

*

*

*

*

*

*

 VAS for dyspepsia

*

      

 Expectations for Relief Scale

 

*

  

*

   

*

 MASS

 

 The CARE measure

 

      

 IRI

 

      

 NDI

 

*

      

 SF-36

 

*

      

 STAI

 

*

      

 PRISM

 

*

      

 Nutrition drink test

 

*

      

Intervention

         

 Acupuncture treatment

 

  1. *, conducted before acupuncture treatment; , conducted after acupuncture treatment; BDI, Beck Depression Inventory; AR Adequate Relief, VAS Visual analog scale, MASS Massachusetts General Hospital Acupuncture Sensation Scale, CARE Consultation and Relational Empathy, IRI Interpersonal Reactivty Index, NDI Nepean Dyspepsia Index, SF-36 Short Form 36-item Health Survey, STAI State-Trait Anxiety Inventory, PRISM Pictorial Representation of Illness and Self Measure