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Table 1 Summary of assessments at procedures (x shows the items to be carried out at each visit)

From: Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

Procedure Screening (visit 1)1 Treatment phase Follow-up (visit 10)
22 3 43 5 6 7 8 9
Obtain informed consent x          
Hwa-byung SCID x          
Take history1 x          
Collect demographic information2 x          
Randomization   x         
 STAI   x        x  
 H-scale   x        x  
 CES-D   x        x  
 WHOQOL-BREF   x        x  
H-VAS   x    x     x x
Measure salivary cortisol   x        x  
Treatment session   x x x x x x x x  
Safety assessment9    x x x x x x x x
  1. Abbreviations: CES-D, Center for Epidemiologic Studies Depression Scale; H-scale, Hwa-byung scale; H-VAS, Hwa-byung visual analogue scale for primary symptoms; STAI, State-Trait Anxiety Inventory (STAI); WHOQOL-BREF, World Health Organization Quality of Life scale, brief version.
  2. 1 Visit 1: acquisition of informed consent and performance of screening procedure.
  3. 2 Visit 2: randomization and performance of outcome assessment for baseline.
  4. 3 Visit 4: performance of outcome assessment for primary objective.
  5. 4 Drug history for the past month, allergy and disease history, obstetric history, history of menarche and menstrual periods.
  6. 5 Date of birth, age, height, and weight.
  7. 6 Medical examination by interview.
  8. 7 A scale for diagnosing blood stagnation; has not been published.
  9. 8 100 mm visual analogue scale to measure mean and the maximum pain during the menstrual period.
  10. 9 Measurement of aspartate and alanine aminotransferases, blood urea nitrogen, creatinine, and alkaline phosphatase.
  11. 10 White and red blood cell counts, hemoglobin, hematocrit, platelets.
  12. 11 Protein, glucose, urobilinogen, ketone, red and white blood cells, squamous cells.
  13. 12 Medical examination and self-report of adverse events.