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

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

Procedure	Screening (visit 1)¹	Treatment phase								Follow-up (visit 10)
		Visit
		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
Scales
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

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.
¹ Visit 1: acquisition of informed consent and performance of screening procedure.
² Visit 2: randomization and performance of outcome assessment for baseline.
³ Visit 4: performance of outcome assessment for primary objective.
4 Drug history for the past month, allergy and disease history, obstetric history, history of menarche and menstrual periods.
⁵ Date of birth, age, height, and weight.
⁶ Medical examination by interview.
⁷ A scale for diagnosing blood stagnation; has not been published.
⁸ 100 mm visual analogue scale to measure mean and the maximum pain during the menstrual period.
⁹ Measurement of aspartate and alanine aminotransferases, blood urea nitrogen, creatinine, and alkaline phosphatase.
¹⁰ White and red blood cell counts, hemoglobin, hematocrit, platelets.
¹¹ Protein, glucose, urobilinogen, ketone, red and white blood cells, squamous cells.
¹² Medical examination and self-report of adverse events.

ISSN: 1745-6215