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The effect of Oriental medicine Music THerapy on "hwa-byung" patients
ISRCTN ISRCTN11939282
DOI 10.1186/ISRCTN11939282
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of Oriental medicine Music THerapy on "hwa-byung" patients
Scientific title The effect of Oriental medicine Music THerapy on "hwa-byung" patients: a randomized double-blind parallel group trial
Acronym MuTH
Serial number at source CCRG_2011_Music
Study hypothesis Oriental medicine music therapy will be more effective than placebo music therapy: Improved State-Trait Anxiety Inventory (STAI) score

Please note that as of 22/08/2012 the anticipated end date of this trial was changed from 01/04/2012 to 31/12/2012
Lay summary Lay summary under review 3
Ethics approval IRB of Kyung Hee University Gangdong, 1 April 2011, ref number KHNMC-OH-IRB 2010-014
Study design Randomized double-blind parallel group trial
Countries of recruitment Korea, South
Disease/condition/study domain Hwa-byung (anger syndrome)
Participants - inclusion criteria 1. Male or female over 20
2. Diagnosed as hwa-byung using hwa-byung Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
3. Written informed consent form taken
4. Has no problems with communication (reading, writing, listening, speaking, etc.)
Participants - exclusion criteria 1. In need of regular medication or psychotherapy
2. Has a severe neuro- or psychiatric disorder
3. Has a history of major neuro-psychiatric disorder (autism, learning disorder, mental retardation etc.)
3. Had a change in medication of anti-depressant or barbiturate in the past one month
4. Seriously irritable patient
5. Participated in any other clinical trial in the past 1 month from the screening day
6. Had a regular mind-body relaxation training in the past 1 year, music therapy, qigong, yoga, and meditation
7. Cannot understand written informed consent form or follow this study
8. Mental retardation and mental or emotional problems.
Anticipated start date 06/04/2011
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 48 (Oriental Medicine Music Therapy 24, Placebo Music Therapy 24)
Interventions 1. Oriental medicine music therapy (active music therapy) and placebo music therapy
2. Treatment: 2 sessions/week
3. Duration: 4 weeks
4. Followed up for 4 weeks

Contact details of Principal Investigator:
Dr Kim Jong-Woo
Kyung Hee University Gangdong Oriental Medical Center
149 Sangil-Dong
Gangdong-Gu
Seoul
363-951
South Korea
Primary outcome measure(s) State-Trait Anxiety Inventory (STAI)
Measured at Visit 2 (Day 1, their first treatment session), Visit 9 (Day 25, their last treatment session), and Visit 10 (Day 53, the follow-up).
Secondary outcome measure(s) 1. Hwa-byung scale
2. The Center for Epidemiologic Studies Depression Scale (CES-D)
3. State-Trait Anger Expression Inventory (STAXI)
4. Hwa-byung primary symptoms Visual Analogue Scale (VAS)
5. World Health Organization Quality of Life (WHOQOL-BREF)
6. Salivary cortisol
Measured at Visit 2 (Day 1, their first treatment session), Visit 9 (Day 25, their last treatment session), and Visit 10 (Day 53, the follow-up).
Sources of funding Korea Health Industry Development Institute (Korea, South)
Trial website
Publications 1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/22963388
Contact name Dr  Ko  Seoung-Gyu
  Address Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
1 Hoegi-dong
Dongdaemun-gu
  City/town Seoul
  Zip/Postcode 363-951
  Country Korea, South
Sponsor Korea Health Industry Development Institute (Korea, South)
  Address 643 Yeonje-ri
Gangoe-myeon
Cheongwon-gun
  City/town Chuncheongbukdo
  Zip/Postcode 363-951
  Country Korea, South
  Sponsor website: http://www.khidi.or.kr/
Date applied 27/07/2011
Last edited 01/07/2013
Date ISRCTN assigned 19/09/2011
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