Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- MMJ Labs LLC
- 入组人数
- 345
- 主要终点
- Pain of immunization
研究概览
简要总结
The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.
详细描述
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.
Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children receiving routine immunizations
排除标准
- •no caregiver present
- •chronic illness requiring frequent injections
- •clear cognitive impairments affecting communication
结局指标
主要结局
Pain of immunization
时间窗: 5 minutes during or immediately after immunizations
Infants' and toddlers' pain is assessed by coding videotapes using the FLACC (face, legs, activity, crying and consolability) scale. Patients age 4 and older rate pain using self-report via the Faces Pain Scale Revised.
次要结局
- Pain from immunization using observational measures(5 minutes immediately following immunization)
- Treatment satisfaction(5 minutes after immunizations)