Ryu Hwa Yeon, Kang Jae Hui
Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University.
Department of Acupuncture and Moxibustion Medicine, Cheonan Korean Medicine Hospital of Daejeon University, Daejeon, South Korea.
Medicine (Baltimore). 2020 Jan;99(5):e18705. doi: 10.1097/MD.0000000000018705.
The bloodletting device has been used by many institutions for about 100 years. Many patients feel fear from the pain caused by applying the bloodletting device for treatment. We used bloodletting device using the principle of "prestimulation neurodisturbance," which can mask the subject undetectable for pain. In this study, we will investigate pain of bloodletting device during blood collection and will identify the safety of the device.
This study will be a randomized, controlled, double-blind, and matched-paired-designed clinical trial. Four groups, RTLC, LTRC, RCLT, and LCRT (T = test device, C = control device, L = left, R = right), will be randomly allocated. Total duration of the clinical trial will be 3 months. The subjects will be performed from 1 to 3 times only on the day of the procedure. The primary outcomes will be measured using pain visual analog scale score and the secondary outcomes will include verbal rating scale and the time at which the pain disappears after blood collection (second), the total number of "nonbleeding" cases and subjects, the number of "blood collection failure" and subjects, the presence of "delayed hemostasis," and the number of subjects. Repeated-measure analysis will be used to measure primary efficacy based on full analysis set.
This study has limited inclusion and exclusion criteria and a well-controlled intervention, and it will be the first randomized controlled trial to investigate pain of bloodletting device using the principle of "prestimulation neurodisturbance." This study provides insights into the underlying mechanisms of the pain-reducing effect of the developed bloodletting device and will lay the groundwork for further studies.
放血装置已被许多机构使用约100年。许多患者因使用放血装置进行治疗时产生的疼痛而感到恐惧。我们使用了基于“预刺激神经干扰”原理的放血装置，该装置可以掩盖受试者无法察觉的疼痛。在本研究中，我们将调查放血装置在采血过程中的疼痛情况，并确定该装置的安全性。
本研究将是一项随机、对照、双盲和配对设计的临床试验。将随机分配四组，即RTLC、LTRC、RCLT和LCRT（T = 测试装置，C = 对照装置，L = 左，R = 右）。临床试验的总持续时间将为3个月。受试者仅在操作当天进行1至3次。主要结局将使用疼痛视觉模拟量表评分进行测量，次要结局将包括言语评定量表以及采血后疼痛消失的时间（秒）、“无出血”病例和受试者的总数、“采血失败”的数量和受试者、“延迟止血”的存在情况以及受试者的数量。将使用重复测量分析基于全分析集来测量主要疗效。
本研究具有有限的纳入和排除标准以及良好控制的干预措施，并且它将是第一项使用“预刺激神经干扰”原理研究放血装置疼痛的随机对照试验。本研究为所开发的放血装置减轻疼痛效果的潜在机制提供了见解，并将为进一步研究奠定基础。
