A pilot study to evaluate the effect of TWO kinds of MEditation programs on Hwa-byung patients

ISRCTN	ISRCTN75740459
DOI	https://doi.org/10.1186/ISRCTN75740459
Secondary identifying numbers	CCRG_2011_Meditation

Submission date: 02/06/2012
Registration date: 21/06/2012
Last edited: 29/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Hwa-byung is a Korean culture-bound syndrome, known as anger syndrome. Angry feelings should be vented properly, but blocked feelings accumulating in the patients mind become injurious emotions. These blocked emotions, such as stress, angeror anxiety, cause hwa-byung. Hwa-byung has various symptoms, including 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, palpitations, pounding heart, respiratory stuffiness/oppression, masses in the epigastrium or chest, dry mouth, insomnia, and lack of appetite. Metta is usually translated in English as loving-kindness. It means love, not limited to the specific one, but expanded to all independent of all self-interest. It includes friendship, non-violence, and a strong wish for the happiness of others. Metta meditation is a kind of sitting or walking meditation, based on Buddhist practice. It consists of loving-kindness meditation, comparison meditation, and compassionate mind training. The aim of this study is to evaluate the effect of two kinds of meditation programs on Hwa-byung patients.

Who can participate?
Men and women between 20 and 65 years of age who have been diagnosed as Hwa-byung can participate in this trial.

What does the study involve?
Participants will be randomly allocated to Metta meditation or basic meditation. Participants will have eight one-hour sessions of meditations, one session per one week for eight weeks in total. The metta meditation in this study will be a sitting form. At the beginning, participants will take a few minutes to quiet mind and body. Next, he/she will recite some phrases to himself/herself. There are no physical activities during the session.

What are the possible benefits and risks of participating?
The investigators hope that metta meditation may improve the participants symptoms, but they cannot guarantee the effectiveness. There are no financial benefits for the participants. Metta meditation does not involve physical activity so the risks of participating will be few.

When is study starting and how long is it expected to run for?
The study starts in March 2012 and will end in December 2012.

Who is funding the study?
Korea Health Industry Development Institute (Republic of Korea).

Who is the main contact?
Dr Jong-Woo Kim
aromaqi@khu.ac.kr

Contact information

Dr Jong-Woo Kim
Scientific

Kyung Hee University Gangdong Oriental Medical Center
149 Sangil-Dong
Gangdong-Gu
Seoul
134-727
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)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomized controlled, open-labelled, single-center, 8-week pilot study to assess the effectiveness of TWO kinds of MEditation programs on the emotions of Hwa-byung patients
Study acronym	TwoMe
Study objectives	The primary aim of this study is to evaluate the effect of two kinds of meditation programs on Hwa-byung patients.
Ethics approval(s)	IRB of Kyung Hee University Gangdong, 01/02/2012, ref: KHNMC-OH-IRB 2011-011
Health condition(s) or problem(s) studied	Hwa-byung (anger syndrome)
Intervention	1. Metta meditation or basic meditation 2. Treatment: one session/week 3. Duration: 8 weeks 4. Followed up for 4 weeks
Intervention type	Other
Primary outcome measure	Hwa-byung symptoms scale at baseline (before the treatment) and post treatment (after eight sessions of treatment).
Secondary outcome measures	1. State-Trait Anger Expression Inventory (STAXI) (only 20 items in state anger and trait anger) 2. Hospital Anxiety and Depression Scale of Korea (HAD) 3. Korean version of Mindfulness Attention Awareness Scale (K-MAAS) 4. Korean version of Difficulties in Emotion Regulation Scale (K-DERS) 5. Self-Compassion Scale (SCS) 6. Acceptance and Action Questionnaire (AAQ) Measured at baseline (before the treatment) and post treatment (after eight sessions of treatment).
Overall study start date	01/02/2012
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 (metta meditation 20, basic meditation 20)
Key inclusion criteria	1. Male or female from 20 to 65 years old 2. Diagnosed as hwa-byung using hwa-byung SCID (Structured Clinical Interview for DSM-W) 3. Written informed consent form taken 4. Has no problems with communication (reading, writing, listening, speaking etc)
Key exclusion criteria	1. Has a severe neuro or psychiatric disorder 2. Has a history of major neuro-psychiatric disorder (autism, learning disorder, mental retardation etc.) 3. If the patient was in need of regular medication or psychotherapy, had a change in medication or dose of anti-depressant, barbiturate, hormone therapy in the past month 4. Seriously irritable patient 5. Participated in any other clinical trial within last one month from the screening day 6. Had a regular mind-body relaxation training more than one month within last year including any kind of meditation, qigong, etc. 7. Cannot understand written informed consent form or follow this study because of mental retardation, mental or emotional problems
Date of first enrolment	01/02/2012
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

Korea, South

Study participating centre

Kyung Hee University Gangdong Oriental Medical Center

Seoul
134-727
Korea, South

Sponsor information

Korea Health Industry Development Institute (Korea, South)
Industry

643 Yeonje-ri
Gangoe-myeon
Cheongwon-gun
Chuncheongbukdo
363-951
Korea, South

Website	http://www.khidi.or.kr/eng/index.jsp
"ROR"	https://ror.org/00fdzyk40

Funders

Funder type

Research organisation

Korea Health Industry Development Institute (Korea)
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