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. 2012 Aug 21;12:132. doi: 10.1186/1472-6882-12-132

Table 2.

Study Visits

  Visit 1
Daily
Visit 2
Visit 3
Visit 4
Weekly Phone Calls
Visit 5
Screening (within 60 days of baseline) Days (−7 to 70) Baseline Week 0 Week 3 Week 6 Week (−1, 1–2, 4–5 & 7–9) Week 10
Laboratory Values 1
X
 
 
 
 
 
 
Medical Exam/History/Socio-demographics
X
 
 
 
 
 
 
Urine Pregnancy Test 1
X
 
 
 
 
 
 
PRIME-MD2
X
 
 
 
 
 
 
HADS 2
X
 
 
 
X
 
X
BFI 2
X
 
X
X
X
X
X
Concomitant Medication & Supplements
X
 
 
 
 
 
 
Sleep Diary
X
 
 
 
X
 
 
Group Randomization 3
 
 
X
 
 
 
 
Actiwatch Data Collected
 
X
X4
X4
X4
 
X4
LTQL
 
 
X
 
X
 
X
BSAPQ 2
X
 
X
 
X
 
X
GSE 2
 
 
X
 
X
 
X
BPI2
X
 
X
 
X
 
X
Study Logbook
 
X
X
X
X
 
X
PSQI 2
X
 
 
 
X
 
X
VAS for Pain 2
X
 
 
 
 
 
 
Berlin Questionnaire
X
 
 
 
 
 
 
Therapy Evaluation Questionnaire
 
 
X
 
X
 
 
Perform Acupressure 5
 
 
X
X
X
 
 
Assess Treatment Fidelity – Self efficacy Measure
 
 
 
X
X
 
 
Adverse Events
 
 
 
X
X
X
X
Assessment of Blinding         X    

1 Complete Blood Count; blood for correlative tests, blood for future DNA analysis, Urine pregnancy test as appropriate.

2 HADS = Hospital Anxiety Depression Scale; BFI = Brief Fatigue Inventory; and PSQI = Pittsburgh Sleep Quality Index; LTQL = Long Term Quality of Life Instrument; BSAPQ = Breast and Surrounding Areas Pain Questionnaire; GSE = General Self Efficacy Scale; BPI = Brief Pain Inventory; VAS for Pain = Visual Analog; PRIME-MD = Primary Care Evaluation of Mental Disorders.

3 Participants are randomized to one of three treatments: Standard of Care; Relaxation Acupressure; or Stimulating Acupressure.

4 Data file downloaded at these visits.

5 Does not apply to standard of care arm.