Plain English Summary
Background and study aims
Hwa-byung is a Korean syndrome, also known as anger syndrome. Angry feelings should be vented properly, but blocked feelings are accumulated in the patient’s mind. These blocked emotions cause hwa-byung. The most common feelings causing hwa-byung are vexation, mortification, regret or feeling victimized or otherwise mistreated. The source of the stress is feeling like they are victims in their daily life. It is usually associated with a stressful relationship, especially between a housewife and her mother-in-law and/or husband. Most hwa-byung patients are middle-aged or older women. Hwa-byung includes various symptoms, especially a sensation of heat in the body (including hot flushes, redness of the face, and sensitivity to hot environments), a feeling of tension in the chest, palpitation/heart-pounding, respiratory stuffiness/oppression, dry mouth, insomnia and anorexia. Oriental Medicine Music Therapy is a kind of performance that goes beyond listening to the music. During the treatment session, participants create sounds with their own voice or musical instruments like drums, maracas, hand-bells, etc. These performances can relax the hwa-byung patient’s mind and body, reducing symptoms of hwa-byung. The aim of this study is to assess the effect of Oriental Medicine Music Therapy on hwa-byung patients.
Who can participate?
People aged over 20 diagnosed with hwa-byung
What does the study involve?
Participants are randomly allocated to receive either Oriental Medicine Music Therapy or placebo (dummy) music therapy. Participants receive the treatment two times per week for 4 weeks. That makes a total of eight sessions. A series of questionnaires is given before the first treatment and the last treatment. After the treatment phase, participants are followed up for 4 weeks.
What are the possible benefits and risks of participating?
This study hopes to demonstrate the effectiveness of Oriental Medicine Music Therapy and help patients find relief from their symptoms. There are no anticipated medical risks or potential drawbacks to patients. The participants receive Oriental Medicine Music Therapy for free. If the participants receiving placebo music therapy want to have Oriental Medicine Music Therapy session, it will be given for free after the study. All laboratory test fees are waived.
Where is the study run from?
Hwa-byung Stress Clinic at Gangdong Kyung Hee University (South Korea)
When is the study starting and how long is it expected to run for?
April 2011 to December 2012
Who is funding the study?
Korean Health Industry Development Institute (KHIDI) (South Korea)
Who is the main contact?
Dr Ko Seoung-Gyu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ko Seoung-Gyu
ORCID ID
Contact details
Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
1 Hoegi-dong
Dongdaemun-gu
Seoul
363-951
Korea
South
Type
Scientific
Additional contact
Dr Kim Jong-Woo
ORCID ID
Contact details
Kyung Hee University Gangdong Oriental Medical Center
149 Sangil-Dong
Gangdong-Gu
Seoul
363-951
Korea
South
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCRG_2011_Music
Study information
Scientific title
The effect of Oriental medicine Music THerapy on "hwa-byung" patients: a randomized double-blind parallel-group trial
Acronym
MuTH
Study hypothesis
Oriental medicine music therapy will be more effective than placebo music therapy: Improved State-Trait Anxiety Inventory (STAI) score.
Ethics approval
IRB of Kyung Hee University Gangdong, 01/04/2011, ref: KHNMC-OH-IRB 2010-014
Study design
Randomized double-blind parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Hwa-byung (anger syndrome)
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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).
Overall trial start date
06/04/2011
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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.)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 (Oriental Medicine Music Therapy 24, Placebo Music Therapy 24)
Participant 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.
Recruitment start date
06/04/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Korea, South
Trial participating centre
Kyung Hee University
Seoul
363-951
Korea, South
Sponsor information
Organisation
Korea Health Industry Development Institute (Korea, South)
Sponsor details
643 Yeonje-ri
Gangoe-myeon
Cheongwon-gun
Chuncheongbukdo
363-951
Korea
South
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Korea Health Industry Development Institute (Korea, South)
Alternative name(s)
KHIDI
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22963388
Publication citations
-
Protocol
Park JS, Park S, Cheon CH, Jang BH, Lee SH, Lee SH, Chung SY, Kim JW, Jeon CY, Park JH, Shin YC, Ko SG, Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial., Trials, 2012, 13, 161, doi: 10.1186/1745-6215-13-161.