Condition category
Mental and Behavioural Disorders
Date applied
27/07/2011
Date assigned
19/09/2011
Last edited
09/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.khidi.or.kr/

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

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22963388

Publication citations

  1. 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.

Additional files

Editorial Notes

09/09/2016: Plain English summary added. 22/08/2012: the overall trial end date was changed from 01/04/2012 to 31/12/2012.