Methods/design: The proposed study is a single-center, double-blind, randomized, controlled trial with two
parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total,
48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants
fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the
OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice
per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the
secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale
(CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality
of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete
questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of
all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a
total of 53 days.
Methods/design: The proposed study is a single-center, double-blind, randomized, controlled trial with twoparallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total,48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participantsfulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: theOMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twiceper week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and thesecondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale(CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Qualityof Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to completequestionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end ofall trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take atotal of 53 days.
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