• Title, Summary, Keyword: Pilot protocol study

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Clinical Research of Korean Medicine and Western Medicine Collaboration Registry for Low Back Pain: A Pilot Study Protocol (요통에 대한 협진 레지스트리 임상연구: 예비 임상연구 프로토콜)

  • Kim, Byung-Jun;Shin, Byung-Cheul;Heo, In;Lim, Kyeong-Tae;Park, In Hwa;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.3
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    • pp.117-124
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    • 2017
  • Objectives Collaboration medicine means cooperate with western medicine and traditional korean medicine to treat the one disease. In Korea, Interest in collaboration medicine is increasing, But the number of studies is scare. Therefore we will conduct collaboration medicine study for the low back pain. Methods This study composes prospective cohort registry study. If the patients who need collaboration medicine by doctor come, we will ask regist this study. And patient select collaboration treatment group and single treatment group. Total 120 patients will recruit from collaboration pilot project hospitals. Each group patient will observed 4 weeks. Telephone research will conducted after 1 month from the last follow up. During the treatment, patients are treated usual treatment type of each medicine. Primary outcome is NRS and secondary outcomes are EQ-5D and ODI. We will analyze difference of 1 week and 4 week outcome result. Conclusions This study is the first large sample size study effect of collaboration medicine in Korea for low back pain. We check present collaboration system and improve collaboration system. Aim of this study is to find the effectiveness collaboration medicine for low back pain in the real condition. And we expect this pilot study will provide the clinical collaboration information and basis.

Exploring the Effect of Mental Demand in Web Searches: A Pilot Study

  • Na, Kyoungsik
    • Journal of the Korean Society for Library and Information Science
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    • v.48 no.2
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    • pp.379-398
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    • 2014
  • This pilot study explored the effect of mental demand on a Web searcher's thoughts, emotions, efforts, and performance in Web searches in order to address whether or not there is any difference between searchers exposed to mental demand manipulation and searchers not exposed. Research data were collected via think-aloud protocol (TAP) with a dual-task in experiments and interviews with 10 subjects who participated in this study. For the searcher's thoughts, relevance judgment was found to be hindered by mental demand. For the searcher's emotions, the experimental group was more frustrated than the control group. With respect to the searcher's efforts, searchers for the experimental group with mental demand manipulation were more likely to spend more time, make fewer queries, and visit fewer pages but work harder to find more relevant information that they needed. Lastly, with regard to the searcher's performance, it is likely that performance was highly dependent upon the completion of the search tasks for both groups. The NASA-TLX six components and cognitive load scores of searchers did not make a significant difference in the outcome. The findings support the use of a dual-task methodology as a promising approach for the assessment of cognitive load induced by complex Web searches.

Efficacy of Electroacupuncture using an Insulated Needle in Adults with Abdominal Obesity: A Pilot Study

  • Oh, Seo Young;Lee, Hyun;Yun, Gee Won;Kang, Jae Hui
    • Journal of Acupuncture Research
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    • v.34 no.2
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    • pp.49-59
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    • 2017
  • Objectives : This study evaluated the efficacy of electroacupuncture therapy using an insulated needle in adults with abdominal obesity. Methods : This study was a randomized, double-blind, parallel-designed pilot trial. Sixteen participants eligible according to the inclusion and exclusion criteria were randomly divided into an insulated needle group and a control group. Insulated or common needles were inserted at acupoints located on the abdomen (CV12, CV6, ST25, ST27, SP15) and were electrically stimulated for 30 minutes (16 Hz, within tolerable strength). A total of 10 sessions of treatment were performed twice per week for 5 weeks. All participants were requested to maintain their usual diet and lifestyle. The outcome measures were waist circumference (WC), waist-to-hip ratio (WHR), and abdominal computed tomography (CT) of the total fat area (TFA), subcutaneous fat area (SFA), and visceral fat area (VFA). Results : A total of 12 participants divided into the insulated needle group (n = 5) and the control group (n = 7; common needle) were treated for 10 sessions and analyzed per-protocol (PP). WC decreased significantly after 10 sessions in both groups. The WC, TFA, SFA, and VFA of abdominal CT in the insulated needle group decreased more than in the control group; however, there were no significant differences in any parameter between the insulated needle group and the control group. Patients in the insulated needle group were more strongly stimulated with electrical stimulation than patients in the control group. Conclusion : Electroacupuncture using insulated needles in adults with abdominal obesity might be a more effective treatment than common needles. Additional studies are required to compensate for the limitations of this pilot study and to verify the results and efficacy.

Development of implant loading device for animal study about various loading protocol: a pilot study

  • Yoon, Joon-Ho;Park, Young-Bum;Cho, Yuna;Kim, Chang-Sung;Choi, Seong-Ho;Moon, Hong-Seok;Lee, Keun-Woo;Shim, June-Sung
    • The Journal of Advanced Prosthodontics
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    • v.4 no.4
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    • pp.227-234
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    • 2012
  • PURPOSE. The aims of this pilot study were to introduce implant loading devices designed for animal study and to evaluate the validity of the load transmission ability of the loading devices. MATERIALS AND METHODS. Implant loading devices were specially designed and fabricated with two implant abutments and cast metal bars, and orthodontic expansion screw. In six Beagles, all premolars were extracted and two implants were placed in each side of the mandibles. The loading device was inserted two weeks after the implant placement. According to the loading protocol, the load was applied to the implants with different time and method, simulating early, progressive, and delayed loading. The implants were clinically evaluated and the loading devices were removed and replaced to the master cast, followed by stress-strain analysis. Descriptive statistics of remained strain (${\mu}{\varepsilon}$) was evaluated after repeating three cycles of the loading device activation. Statistic analysis was performed using nonparametric, independent t-test with 5% significance level and Friedman's test was also used for verification. RESULTS. The loading devices were in good action. However, four implants in three Beagles showed loss of osseointegration. In stress-strain analysis, loading devices showed similar amount of increase in the remained strain after applying 1-unit load for three times. CONCLUSION. Specialized design of the implant loading device was introduced. The loading device applied similar amount of loads near the implant after each 1-unit loading. However, the direction of the loads was not parallel to the long axis of the implants as predicted before the study.

Development of Preflight Safety Protocol for Training Aircraft (훈련용 항공기 비행전 안전 프로토콜 개발)

  • Lee, Jaehyeon;Hwang, Sunil;Park, Hongseon;Lee, Sungwoo;So, Youngsub
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.28 no.1
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    • pp.66-74
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    • 2020
  • With the development of the aviation industry in Korea, the number of aircrafts has increased every year. About 10 flight departments have been established at domestic universities, and flight training is conducted until the course of commercial pilot certificate. In addition, private aviation institutes using Muan airport as a base have also increased, and the number of training aircrafts in the eastern and western regions of Jeonnam region has increased dramatically. Along with an increase in the number of training aircrafts, aviation accidents have also increased. From April 2018 to September 2019, 11 accidents occurred at Muan airport and Yeosu airport. This study aims to develop a pre-flight safety protocol to promote flight training safety. Three aspects-including technical factors, human factors, and organizational factors-were considered in this study.

Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

Analysis of Differences in Attention Allocation Patterns between Expert and Novice Pilots (숙련급 조종사와 초급 조종사와의 주의 배분 차이 분석)

  • Park, Sang-Su;Kim, Gi-U;Myeong, No-Hae
    • Journal of the Ergonomics Society of Korea
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    • v.23 no.1
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    • pp.49-63
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    • 2004
  • In this study. differences in attention allocation patterns between expert and novIce pilots were investigated by a verbal protocol when pilots were engaged in a task during the instrument flight. Ten pilots including experts and novices were participated to conduct a pre-determined task(a fix-to-fix) on F-5E Cockpit Procedure Trainer Simulator. Experts show better performance as expected with more stable variations in speed. altitude. and attitude. In attention allocation patterns. novices allocated about 83% of attentional resources on the primary instruments (airspeed indicator. altitude indicator. and attitude) relating to the task of the basic flight while experts spent 57%. This difference in the availability of attentional resources allowed expert pilots to accomplish the task better than novices. In other words. training a pilot should consider a program for building up wider instrument scanning patterns to become an expert in a shorter time.

Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong;Seo, Jung-Chul;Park, Sung-Hoon;Kwak, Min-Ah;Shin, Im Hee;Min, Bo-Mi;Cho, Min-Su;Roh, Woon-Seok;Jung, Jin-Yong
    • Journal of Pharmacopuncture
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    • v.18 no.1
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    • pp.79-85
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    • 2015
  • Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women with Overactive Bladder; a Pilot Study of Randomized Clinical Controlled Trial (폐경 여성의 과민성 방광에 대한 전침 치료와 침 치료의 유효성과 안전성 평가 ; 무작위 대조군 예비 임상시험)

  • Nam, Eun-Young;Jung, Seung-Hyun;Bae, In-Suk;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.1
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    • pp.84-98
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    • 2018
  • Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.