The effect of oriental medicine music therapy on "hwa-byung" patients
| ISRCTN | ISRCTN11939282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11939282 |
| Secondary identifying numbers | CCRG_2011_Music |
- Submission date
- 27/07/2011
- Registration date
- 19/09/2011
- Last edited
- 09/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
1 Hoegi-dong
Dongdaemun-gu
Seoul
363-951
Korea, South
Scientific
Kyung Hee University Gangdong Oriental Medical Center
149 Sangil-Dong
Gangdong-Gu
Seoul
363-951
Korea, South
Study information
| Study design | Randomized double-blind parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effect of Oriental medicine Music THerapy on "hwa-byung" patients: a randomized double-blind parallel-group trial |
| Study acronym | MuTH |
| Study objectives | Oriental medicine music therapy will be more effective than placebo music therapy: Improved State-Trait Anxiety Inventory (STAI) score. |
| Ethics approval(s) | IRB of Kyung Hee University Gangdong, 01/04/2011, ref: KHNMC-OH-IRB 2010-014 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 06/04/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 (Oriental Medicine Music Therapy 24, Placebo Music Therapy 24) |
| Key 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.) |
| Key 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. |
| Date of first enrolment | 06/04/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
363-951
Korea, South
Sponsor information
Industry
643 Yeonje-ri
Gangoe-myeon
Cheongwon-gun
Chuncheongbukdo
363-951
Korea, South
| Website | http://www.khidi.or.kr/ |
|---|---|
"ROR" |
https://ror.org/00fdzyk40 |
Funders
Funder type
Industry
Government organisation / National government
- Alternative name(s)
- KHIDI
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/09/2012 | Yes | No |
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.
