• Title/Summary/Keyword: Pilot protocol study

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Preliminary Study on Developing Protocol for Music Therapy Assessment for Cognitive and Emotional-Behavioral Domain using Rhythm (MACED-Rhythm) (인지 및 정서행동 영역에서의 음악치료 사정을 위한 리듬 프로토콜(MACED-Rhythm) 개발 예비 연구)

  • Duerksen, George;Chong, Hyun Ju
    • Journal of Music and Human Behavior
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    • v.10 no.1
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    • pp.67-83
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    • 2013
  • Assessment in music therapy is a vital part for both the therapist and client in the process of therapy. Based on what is assessed, objectives are identified to formulate specific action procedures and strategies. The existing assessment tools involve lists of skills and behaviors in developmental domains without the music assessment protocol. In this study, the authors attempted to develop an assessment protocol using rhythm production for assessing skills in cognitive and emotional-behavior domain, namely Music Therapy Assessment for Cognitive and Emotional Behaviors (MACEB). The test items of the MACEB-Rhythm were developed using rhythmic patterns varying in terms of item difficulty, which are based on the various degree of clarity in the grouping/gestalt, saliency in part-whole relationship, and complexity in repetition vs. variability. Also the developed tool purported to examine one's level of emotional behavior trait by analyzing performance of musical parameters such as tempo, pacing, and loudness in the reproduced output. In order to verify the logical sequencing of test items, firstly 61 subjects participated in verifying the item difficulty for the selected 15 pilot items. The test items were revised and re-sequenced based on the gathered scores of item difficulty. In the second procedure, seven experts in the fields of music education, music therapy and music psychology whose research interest lie in music cognition revised the developed rhythm protocol items focusing on learning sequence, cognitive process and feasibility for skills assessment. The study attempted to provide foundations for using rhythm as an assessment protocol prior to its verification of assessment validity and reliability.

Indoor and Personal Exposure to Carbon Monoxide in Homes (一酸化炭素의 家庭內 濃度 및 主婦의 個人曝露濃度에 關한 調査硏究)

  • 김윤신;손부순;유행행웅
    • Journal of Korean Society for Atmospheric Environment
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    • v.6 no.1
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    • pp.97-102
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    • 1990
  • A pilot field study was conducted to measure indoor and personal exposure to carbon monoxide (CO) levels using personal monitors from January to February in 1989. The principal objectives of the study was to design and evaluate the research protocol and the instrumentation performance for application to the conduct of a large-scale personal monitoring program. The mean CO concentrations in kitchen and in bedroom were 23.4 and 11.9 ppm, respectively, while mean concentration of personal CO exposure was 18.9 ppm. It was found that the mean CO concentrations in kitchen exceeded 20 ppm of the Korea ambient CO standard(8-hr average) not to be exceeded more than three times per year. The results suggest that indoor CO levels in Korean houses appear to be affected by use of coal briquette for heating any cooking.

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The pilot study for the effects of Doin-Angyo program in reducing stress among high school students in Gyeongsangbukdo, Korea (경상북도 일부 고교생을 대상으로 한 도인안교의 스트레스 저하 효과에 대한 파일럿 연구)

  • Park, Hye Jung;Lee, Sangjae;Lim, Byungmook
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.2
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    • pp.59-67
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    • 2014
  • Objective : This study was to examine the effects of Doin-Angyo program, evidenced by East Asian Medicine literatures, on stress among smoking adolescents. Method : This study was a prospective community trial using a one-group, pretest-posttest design. As an intervention, Doin-Angyo program was implemented for 10 minutes per session, 3 days a week, for 6 weeks to smoking students who attend a Girl's high school. Psychological stress was measured by self-report questionnaire and physiological stress was measured by salivary cortisol. The final sample for the questionnaire included 18 participants. In addition, pre- and post-salivary cortisol levels of 24 adolescents participating in the last session were compared in order to identify the acute effects of Doin-Angyo program in reducing stress. Results : There were no significant differences in overall stress-test results from the comparisons before and after the intervention. However, we found a significant going-down of the stress level(p = .032) in the question, "About School-work" among six sub-category questions. From the salivary cortisol tests in the last session, we found, in comparison with the standard salivary cortisol density level, $0.3{\mu}g/dL$, the density level tended to go down(p = .062) when higher than the standard, and it went up(p = .001) when lower than the standard, after 10 minute session. Conclusion : The results of this pilot study supported the partial effect of Doin-Angyo program in reducing the stress levels. The study protocol and results can be used to elaborate the community trials design aiming to prove the effect of Korean Medicine based health promotion modalities.

Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Optimal First-line Eradication Regimens for Helicobacter pylori Infection in Patients with Clarithromycin Resistance: A Pilot Study (국내 클래리스로마이신 내성균에서 가장 효과적인 헬리코박터 제균 치료법)

  • Seo, Min Woo;Jeong, Yeon Jeong;Kim, Joon Sung;Kim, Byung Wook
    • The Korean journal of helicobacter and upper gastrointestinal research
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    • v.18 no.4
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    • pp.242-246
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    • 2018
  • Background/Aims: Helicobacter pylori eradication rates using first-line treatment have decreased due to clarithromycin resistance. The aim of this study was to investigate optimal eradication regimens for patients with clarithromycin resistance in Korea. Materials and Methods: A total of 72 patients with confirmed clarithromycin resistance were enrolled from August 2015 to July 2017. Patients were randomized to a 7-day bismuth quadruple therapy (BQT) regimen or a 7-day metronidazole triple therapy (MTT) regimen. Eradication was confirmed using the $^{13}C$-urea breath test. Results: There were no differences in baseline characteristics between the groups. Intention-to-treat eradication rates were 77.8% for the BQT group and 66.7% for the MTT group (P=0.293). Per protocol eradication rates were 87.5% for the BQT group and 77.4% for the MTT group (P=0.292). Adverse events were more frequent in the BQT group. Conclusions: Eradication rates using MTT were comparable to those using BQT, and adverse events were less frequent in the MTT group. Thus, MTT may be considered as a first-line regimen for patients with clarithromycin resistance. Since this was a pilot study, a study with a large group is required.

Comparison of Cervical Hyeopcheok Acupoint's Depth Change with Cervical Rotation in a Prone Position: Protocol and Pilot Study Result for Accurate Observation of Cervical Hyeopcheok Acupoint by Ultrasonography (복와위에서 경추 회전 시 관찰되는 경추 협척혈의 심도 변화 비교: 초음파를 활용한 경추 협척혈 관찰 프로토콜 및 예비연구 결과)

  • Chu, Hongmin;Park, Kyungtae;Jang, Jongwon;Shin, Hee-Ra;Yang, Muhack;Kim, Doo Ri;Ryu, Won Hyung;Ryu, Ho-sun;Yeom, Seung-Ryong;Lee, Sangkwan;Kim, Cheol-hyun
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.4
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    • pp.81-88
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    • 2019
  • Objectives This study is a preliminary study for safe and accurate cervical Hyeopcheok acupuncture by comparing the depth of cervical Hyeopcheok acupoint with cervical spine rotation. Methods Researchers took ultrasonographic images of cervical Hyeopcheok acupoint during full rotation of cervical spine, 45 degree rotation and neutral condition in a prone position. 4 healthy volunteers were recruited. Results No significant difference in needling depth of cervical Hyeopcheok acupoint was observed. However, there were a differences in anatomical structures' shape such as muscles. Conclusions There are no significant difference in needling depth, but anatomical structures' shape were changed. This result mean that if patient rotate cervical spine during acupuncture treatment, it can occur complications. Thus, when acupuncture treatment on cervical Hyeopcheok acupoint, practioner should make subject's cervical spine alignment corrected and be careful not to change posture during the procedure.

A Clinical Pilot Study of Carthami-Semen Herbal Acupuncture Treatment for Chronic Constipation (만성변비에 대한 홍화약침의 효능 연구)

  • Park, Jae-Woo;Yoon, Seong-Woo;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Acupuncture Research
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    • v.25 no.5
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    • pp.127-137
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    • 2008
  • Objectives : These days, herbal acupuncture therapy is widely applied to many diseases and symptoms by Korean medical doctors in Korea. The aim of this study was to demonstrate the effect of Carthami-Semen herbal acupuncture(CSHA) on chronic constipation. Methods : This single-blind placebo-controlled randomized parellel study enrolled 24 adults with chronic constipation. After one week's run-in period, they were randomly assigned to receive CSHA therapy, or placebo therapy for 4 weeks by 2 times per week. After completing 4 week's therapy, 2 week's follow-up period was continued. During study, defecation frequency, consistency and ease of evacuation were checked before study, every week and follow-up periods. Also, the VAS of constipation, quality of life(QoL) and heart rate variability(HRV : low frequency, high frequency) were checked 3 times totally. Finally, 21 subjects completed the protocol and 20 subjects were analyzed.(1 subject is excluded for analysis because of not following the protocol.) Results : In CSHA group, defecation frequency(continued after 1 week), consistency and ease of evacuation(at 1 week after and follow-up) were increased significantly. The VAS of constipation in CSHA group was significantly decreased. There was no significant change at QoL and HRV. Conclusions : CSHA therapy was effective in treating adults with chronic constipation. Study that have larger case number and longer follow up will be needed in the future.

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Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial (퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구)

  • Jun, Seungah;Park, Mu Seob;Oh, Se Jung;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Hwangbo, Min;Lee, Hyun-Jong;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.33 no.2
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    • pp.67-74
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    • 2016
  • Objectives : The Knee degenerative osteoarthritis patients are not satisfied with the conventional therapies of KDOA, which results in the use of alternative therapies. The miniscalpel acupuncture is effective in treating chronic soft tissue, releasing contractures. However, there is little scientific evidence supporting the use of miniscalpel acupuncture in knee degenerative osteoarthritis. This study was designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis patients. Methods : We describe the protocol for a randomized controlled pilot clinical trial of 5 weeks duration. Twenty patients will be recruited and randomly allocated to two treatment groups: miniscalpel acupuncture treatment(experimental group); and acupuncture and electro-acupuncture treatment(control group). Miniscalpel acupuncture will be performed once with a 1-week interval for 3 weeks. Electro-acupuncture will be administered twice per week for a period of 3 weeks. The primary outcomes will be measured by visual analogue scale and range of motion. The secondary outcomes will be short-form McGill Pain Questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index. Both primary and secondary outcomes will be measured at baseline and at 1, 2, 3 and 5 weeks(i.e. 2 weeks after treatment completion). Conclusions : This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis.

Efficacy and Safety of Geochangmanryeung-dan and Acupuncture on Patient with Spinal Stenosis Treated by Epidural Steroid Injection: a Study Protocol for a Randomized Controlled Pilot Trial (경막외신경차단술로 치료 중인 척추관 협착증 환자에서 거창만령단과 침의 효능 및 안전성 연구(예비임상연구))

  • Lee, Hyun-jong;Lee, Cho In;Lee, Saram;Kwak, Min-Ah;Kwak, Sang Gyu;Roh, Woon-seok;Jung, Jin-yong
    • Korean Journal of Acupuncture
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    • v.32 no.3
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    • pp.99-107
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    • 2015
  • Objectives : This study was designed to obtain basic data for a further large-scale trial as evaluating the efficacy and safety of Geochangmanryeung-dan(GMD) and acupuncture on patient with spinal stenosis treated by epidural steroid injection. Methods: The study is a randomized controlled pilot clinical trial, conducted over 8 weeks. Twenty participants will be recruited and randomly allocated to 2 groups: an experimental(GMD and acupuncture with epidural steroid injection) group and a control(only epidural steroid injection) group. The epidural steroid injection will be administered once per 2 weeks for 6 weeks(3 times in total). GMD will be administered as a dose of 5 pills, 3 times per day, for 6 weeks. Acupuncture will be performed 2 times per week for 6 weeks(12 times in total). The primary outcome will be measured by visual analogue scale and self-rated walking distance. The secondary outcome will be measured by PainVision, short-form McGill Pain Questionnaire, and Oswestry Disability Index. Both primary and secondary outcomes will be measured at baseline, 2, 4, 6, and 8 weeks. The last assessment(at 8 weeks) will be performed 2 weeks after treatment cessation. Conclusions : This clinical trial, as the pilot study for a future large-scale trial, will provide clinical information for evaluating the efficacy and safety of GMD and acupuncture treatment in combination with epidural steroid injection for the treatment of spinal stenosis.

Level of Platelet Derived Growth Factor(PDGF) in Blood Bank Platelet Concentrate (혈액은행 혈소판농축액의 혈소판유래성장인자 분비능)

  • Hong, Yong Taek;Han, Seung Kyu;Lee, Byung Il;Kim, Woo Kyung
    • Archives of Plastic Surgery
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    • v.33 no.6
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    • pp.732-736
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    • 2006
  • Purpose: The purpose of this pilot study was to investigate a potential of platelet concentrate obtained from blood bank(PCBB) in accelerating wound healing and to determine an effective treatment protocol by quantifying levels of platelet derived growth factor (PDGF)-BB in PCBB in vitro. Methods: The first study was designed to investigate quantity of PDGF-BB over stored time of the PCBB. The stored times for each PCBB were 1, 3, 5, 7, 9, 11 and 13 days. The second study was designed to determine efficacy of adding thrombin to stimulate release of PDGF-BB from the platelets of PCBB. The platelets were suspended and incubated in either with or without thrombin. On 30 minutes and days 1, 3, 5, 7 after incubation, the levels of PDGF-BB were measured. Results: PDGF-BB level showed a linear decrease over stored time of PCBB from the first day to the 13th day. Addition of thrombin increased PDGF-BB release from 30 minute through the 5th day. Conclusion: The results indicate that PCBB can provide sufficient amount of growth factors to stimulate wound healing and adding thrombin accelerate it.