Relieving Pediatric Immunization Pain Using A Reusable Personal Device

描述(申请人提供)：针刺是儿童经历的最频繁和最痛苦的医疗程序。由此产生的针头恐惧症降低了父母对免疫接种的依从性，并影响了患者随后与卫生保健系统的互动，导致延误诊断、拒绝献血，甚至死亡。目前的产品依赖于卫生保健专业人员自愿使用凌乱、无效和耗时的干预措施来治疗许多人认为微不足道的疼痛。一种直接提供给消费者的即时有效的可重复使用的止痛装置可以在全球范围内减少发病率和痛苦。快速静脉穿刺法止痛的市场很大；即时免疫止痛法的市场更大，而且还没有开发。一个小的非侵入性装置放置在针部位近端几厘米处，在不影响静脉注射开始成功的情况下显著减少成人静脉穿刺术的疼痛。该项目的第一阶段评估了60名接受入学免疫接种的4-6岁儿童使用该设备与标准护理的疼痛和焦虑缓解、易用性和产品接受度。同时，原型将得到增强，以促进儿科止痛，让人分心的可爱设计。该项目的第二阶段是一项三臂安慰剂对照试验，以显示接受预定疫苗接种的四个年龄组的疼痛减轻：4-6个月(n=120)、12-15个月(n=60)、4-6岁(n=60)和11-12岁(n=75)。使用各种适合年龄的措施，疼痛缓解将由盲人研究人员通过录像带编码进行评估，并在适当的情况下通过父母、护士和儿童自我报告进行评估。患者将被随机分为三组：安慰剂组、标准护理组和使用该设备的组。进一步的专业设计将包括微电子增强、内部冷却组件、可选择抓取和捆绑皮肤以进行自我注射、耐用性测试和电源效率改进。大量的文献都提到了儿科针刺痛的影响和缺乏良好的解决方案。建议的设备克服了现有产品的缺陷，消费者很容易带着去看医生，也很容易使用。这些项目将改善和证明对每个儿童造成的疼痛进行亟需的干预的有效性。公共卫生相关性：该项目寻求在儿童身上优化和测试一种新的廉价的可重复使用的设备，以减少或消除免疫疼痛。儿科针头疼痛导致不愿获得医疗保健、延误诊断、不遵守疫苗和治疗规定以及拒绝献血。减少针头疼痛是一个被忽视的机会，可以在全球范围内减少痛苦。

DESCRIPTION (provided by applicant): Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents' compliance with immunizations and affects patients' subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant. An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large; the market for immediate immunization relief is larger and untapped. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product acceptance using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, placebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be assessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child. PUBLIC HEALTH RELEVANCE: This project seeks to optimize and test in children a novel inexpensive reusable device to reduce or eliminate immunization pain. Pediatric needle pain leads to reluctance to access health care, delayed diagnoses, noncompliance with vaccines and treatment, and refusal to donate blood. Reducing needle pain is an overlooked opportunity to reduce suffering worldwide.