냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정 · 2×2교차설계 탐색적 임상시험계획서 개발
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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초록
Objectives: The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, 2×2 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.
Abstract
Objectives: The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, 2×2 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.
참고문헌 (14)
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