Relieving Pediatric Immunization Pain Using A Reusable Personal Device

描述（由申请人提供）：针扎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混乱、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立即有效的可重复使用的疼痛缓解装置可以减少全世界的发病率和痛苦。快速静脉穿刺止痛市场很大；即时免疫救济的市场更大，尚未开发。一个小的非侵入性装置放置在针头近端几厘米处，可以显著减少成人静脉穿刺疼痛，而不影响静脉注射开始的成功。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相比的疼痛和焦虑缓解、易用性和产品接受度。同时，原型机将通过分散注意力的可爱设计来促进儿童疼痛缓解。该项目的第二阶段是一项三组安慰剂对照试验，以证明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年（n=60）和11-12年（n=75）。采用各种适合年龄的措施，由盲法研究人员通过录像带编码评估疼痛缓解程度，并在适当时由父母、护士和儿童自我报告评估。患者将随机分为三组：安慰剂组、标准治疗组和使用该设备组。进一步的专业设计将包括微电子增强、内部冷却组件、可选择抓取和捆扎皮肤以进行自注入、耐久性测试和能效改进。丰富的文献暗示影响儿科针痛和缺乏一个很好的解决方案。该提议的设备克服了现有产品的缺陷，消费者可以很容易地带到医生那里并自行使用。这些项目将改善和证明急需的干预措施对每个儿童造成的痛苦的效果。

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.