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KMID : 1003820150190020091
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Journal Of The Korea Institute Of Oriental Medical Diagnostics
2015 Volume.19 No. 2 p.91 ~ p.100
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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
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Yu Ha-Na
Kim Ji-Hye
Ku Bon-Cho
Kim Hyun-Ho
Jeon Young-Ju
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Abstract
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Objectives: The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, 2x2 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.
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KEYWORD
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Clinical Protocol , Pulse Diagnosis Device , Cold-heat Intervention , Pulse Wave Variables
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