title: Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as 'anger syndrome'. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients actively move their bodies and play the music. Because Hwa-byung is caused by an accumulation of blocked emotions and anger inside the body, OMMT, because of its active component, is expected to be more efficacious than pre-existing music therapies.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN11939282.
authors.affiliation: Center for Clinical Research and Genomics, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Jeong-Su
authors.initials: JS
authors.lastname: Park
authors.forename: Sunju
authors.initials: S
authors.lastname: Park
authors.forename: Chun-Hoo
authors.initials: CH
authors.lastname: Cheon
authors.forename: Bo-Hyoung
authors.initials: BH
authors.lastname: Jang
authors.forename: Song-Hee
authors.initials: SH
authors.lastname: Lee
authors.forename: Seung-Hyun
authors.initials: SH
authors.lastname: Lee
authors.forename: Sun-Yong
authors.initials: SY
authors.lastname: Chung
authors.forename: Jong-Woo
authors.initials: JW
authors.lastname: Kim
authors.forename: Chan-Yong
authors.initials: CY
authors.lastname: Jeon
authors.forename: Jong-Hyeong
authors.initials: JH
authors.lastname: Park
authors.forename: Yong-Cheol
authors.initials: YC
authors.lastname: Shin
authors.forename: Seong-Gyu
authors.initials: SG
authors.lastname: Ko
mesh_terms: D000786:Anger; D001007:Anxiety / Q000628:therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D055670:Medicine, Korean Traditional; D009147:Music Therapy; D018401:Sample Size