Our hypothesis is that OMMT will produce superior reduction in the STAI measurements compared with a control music therapy that has no physical component.
The aim of this proposed study is to determine the effectiveness of OMMT compared with the control music therapy (CMT) in Hwa-byung patients, especially the anxiety. The aims are: 1) to produce a clinically significant improvement in the STAI scores of patients with Hwa-byung patients; 2) to measure the effect of OMMT on the levels of salivary cortisol; and 2) to identify changes in scores on the H-scale, the CES-D, the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, and the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF) after OMMT
This trial is a single-center, double-blinded, parallel-group randomized controlled trial, which will be performed at the Hwa-byung Stress Clinic, Kyung Hee University Hospital in Gangdong, Seoul. Patients will be recruited through internet advertisements, newspaper advertisements, and official notices posted in the hospital. Patients recruited for the trial will be required to visit the investigational site and sign a written informed consent form. Patients who sign the consent form, who are diagnosed as having Hwa-byung by the Hwa-byung Structured Clinical Interview for DSM (SCID), and who satisfy the inclusion and exclusion criteria will be registered into the clinical trial. The registered patients will be asked to complete the STAI, the H-scale, the CES-D, the H-VAS, and the WHOQOL-BREF. Once 16 patients have been registered randomization will commence, with equal numbers allotted to the the OMMT group and the CMT group. This randomization process will be repeated three times, until 48 patients are divided equally between the two groups. For 4 weeks the patients will receive either OMMT or CMT in groups of eight patients. Patients will complete the H-VAS at sessions 1, 4 and 8 of the trial, and also after session 8 (in week 4). Salivary cortisol will be collected on the day before session 1, and at session 8., and will be collected twice, at 0800 and again at 1700 hours. The time between the screening tests to the end of the trial may vary depending on the patient schedule. From the first session to the last follow-up in week 8, it will take approximately 53 days to complete the study. Figure
is an overview of this proposed trial, and Figure
is an approximate visit schedule.
The inclusion criteria are as follows.
• Male or female over the age of 20 years.
• Diagnosed as having Hwa-byung using the Hwa-byung SCID for DSM-IV.
• Provided written informed consent.
• Have no problems with communication (for example, reading, writing, listening, speaking).
The exclusion criteria of this trial are as follows.
• In need of regular medication or psychotherapy.
• Has a severe neurological or psychiatric disorder.
• Has a history of major neuropsychiatric disorder (for example, autism, learning disorder, mental retardation).
• Has had a change in medication of anti-depressants or barbiturates in the past 1 month.
• Is seriously irritable.
• Participated in any other clinical trials in the past one month from the screening day.
• Had a regular mind/body relaxation training in the past 1 year, such as music therapy, qigong, yoga, or meditation.
• Cannot understand written informed consent form or follow this study.
• Presence of mental retardation and mental or emotional problems.
Various assessments will be carried out at specific visits (see Table
Summary of assessments at procedures (x shows the items to be carried out at each visit)
Oriental medicine music therapy
The OMMT program entails eight sessions of 60 minutes each, conducted twice a week over a period of 4 weeks, and composed of five different levels of activity.
The first level is abdominal breathing for 5 minutes; patients breathe rhythmically to slow Korean folk rhythms called Jinyangjo played by Daegum, a kind of traditional Korean flute. The purpose during this portion of the session is to begin breathing control before the start of the therapy itself. Daegum has the quality of decreasing qi.
The second level involves vocalization and sound. Patients are asked to make the sounds of Kung, Duk, and Dung, which are traditional Korean methods of pronouncing rhythm, using their own voice. This portion of the therapy is conducted twice a week for four weeks in a total of eight sessions 10 minutes each.
The third level of treatment is the five-element rhythm therapy, which takes 10 minutes. Patients stimulate five acupuncture points (GB-20, GB-21, PC-6, ST-40, and GB-31) with maracas to the rhythm of music that has the Wood-qi element of the five elements of music. The objective of this portion is to circulate the blood and qi using Wood-qi music, which has active characteristics when stimulated.
The fourth level is 10 minutes of spreading music therapy, which lets patients play music themselves using Janggu, a traditional percussion instrument.
The fifth level is a 10-minute session of relieving music therapy, in which patients beat out a rhythm with wood blocks, which induces Wood-qi. This is performed to the rhythm of Wood-qi music, which stimulates the liver qi.
The last level is singing with abdominal breathing for 15 minutes. Patients make the sounds of ‘mo’ and ‘mi’, out of ‘ma’, ‘me’, ‘mi’, ‘mo’ and ‘mu’, which have yin characteristics
Control music therapy
The control music therapy program is also carried out for 60 minutes twice a week for 4 weeks, to give a total of eight sessions. Sessions 1 to 4 involve the patients playing different types of traditional music. Each session consists of three or four different types of music and each has the characteristic of reducing qi, making people calm, and lightly stimulating the mind from calmness, heartbreaking sadness, and happiness. From session 1 to 4, the music will be different at each session. The music played in sessions 5 to 8 will be the same music played in the session 1 to 4, but the music will be different at each session.
The primary outcome of this study is the change in the STAI between visit 2 (before treatment and visit 9 (after all sessions are completed).
The secondary outcome measures are the level of salivary cortisol and the scores on the H-scale, the CES-D, the H-VAS, and the WHOQOL-BREF.
All participants will report any adverse events (AEs) experienced during the treatment or follow-up phases. Every AE will be recorded on the case report form (CRF). If the AE is severe and associated with the trial, the participant will be withdrawn from the trial and given medical treatment.
The primary outcome in this trial is the change in STAI between the baseline (visit 2) and after treatment completion (visit 9). The hypothesis is: H0: δ = Δ1-Δ2 < 0 and H1: δ = Δ1-Δ2 ≥ 0, where Δ1 is change in STAI between baseline and visit 9 and the baseline in the OMMT group, and Δ2: is change in STAI between baseline and visit 9 in the control group.
The sample size was calculated based on a qigong
study of heart disease
]. In this study, the participants were divided into two groups: the ‘qigong
’ and ‘relaxing’ groups. After eight sessions, in the ‘qigong
’ group, the mean change in STAI-1 was 8.82 and the standard deviation was 10.385, which is in accordance with a two-tailed, α error of 5% and power of 80% shown in the following equation.
Therefore, we will be randomly assigning 24 participants to each group, assuming a 10% drop-out rate.
Participants will be randomized during visit 2. The randomization process will be started after 16 patients who passed the screening test are enrolled, and randomization will be carried out three times in total. The steps of the randomization will be overseen by an institution unrelated to this trial. Except for the therapist playing the music, anyone related to the trial (investigators, participants, and monitors) will be blinded to the type of music therapy being used, and the outcomes will be evaluated by the investigators, not the therapist. The first step of the randomization process will be to generate a random number to allocate the patient (SPSS software, SPSS Inc., Chicago, IL, USA). The institution in charge of randomization will label the patients as ‘A’ or ‘B’ and report to the trial center, who will randomize the patients accordingly and assign them to the following sessions. The ratio of the OMMT group and the CMT group is 1:1.
The primary endpoint is the STAI. Efficacy analysis will be performed both as per protocol (PP; participants completed the trial without any protocol violation) and as intention to treat (ITT; all randomly assigned participants). The PP dataset will comprise all the patients who completed all the treatment sessions and questionnaires, while the ITT dataset will comprise patients who received at least one treatment session.
The independent t-test will be used to compare the changes in the STAI between visit 2 (baseline) and visit 9 between the OMMT group and the control group. Analysis of covariance (ANCOVA), using the baseline score as a covariate, will be used to analyze the mean change in the STAI, the H-scale, the CES-D, the H-VAS, and the WHOQOL-BREF, and in salivary cortisol levels between the two groups.
Other issues not included in this protocol will follow the Korean Food and Drug Agency Clinical Statistical Guidelines (Medicine 65625–13353, 2000. 12.29).
The Center for Clinical Research and Genomics (CCRG; the contract research organization) will monitor this study. The monitoring procedures will follow the Standard Operating Procedure (SOP)s. Monitoring will begin after the first participant completes the whole period of this study.
The institutional review board (IRB) has approved this clinical trial before participant recruitment. The reference number is KHNMC-OH-IRB 2010–014 (IRB of Kyung Hee University Gangdong Medical Center, approved on 1st of April 2011). Before the trial, the protocol, the CRF, and all the documents to be reviewed by the patients have been previously approved by the IRB of Kyung Hee University Hospital. The trial will be conducted in accordance with the Declaration of Helsinki 2008 and/or the principles of good clinical practice of the Korean Food and Drugs Administration. Before undertaking any study-related procedures, all participants will provide written informed consent.