The Impact of the Certified Child Life Specialist in the Pediatric Primary Care Clinic on Children's Pain During Routine Immunizations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Patient-reported pain
研究概览
简要总结
The purpose of this study is to provide the first systematic evidence that Certified Child Life Specialists reduce pain during vaccine administration and improve caregiver visit satisfaction in the pediatric primary care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 4-12 years of age presenting to MCHS Red Wing for a well child examination and vaccine administration.
- •Parents or caregivers of any age presenting to well child examination with child.
- •Legal guardians of all participants must provide verbal consent.
- •Patients must provide verbal assent for participation.Verbal assent will be waived for children younger than 6 years.
排除标准
- •Children with autism or other severe developmental disabilities.
- •Children must be able to communicate pain before and after vaccine administration using the FPS-R.
结局指标
主要结局
Patient-reported pain
时间窗: Post vaccine administration, approximately 1 hour
Measured using the Faces Pain Scale-Revised (FPS-R). This is a self-report measure of pain validated for children ages 4-16 years of age and approved for the assessment of pediatric pain at Mayo Clinic. The scale utilizes different faces to score the sensation of pain on a 0-to-10 metric.
Observed Negative Emotional Responses
时间窗: Post vaccine administration, approximately 1 hour
Measured using the Children's Emotional Manifestation Scale (CEMS). The CEMS consists of five categories (facial expression, vocalization, activity, interaction, and level of cooperation) with each category scored from 1 to 5, with summed scores from 5 to 25. Higher scores represent more negative emotional behaviors. The scale was initially validated for children 7-12 years of age but has been subsequently used by other studies for children as young as 4 years of age.
次要结局
- Caregiver visit satisfaction(Post vaccine administration, approximately 1 hour)
研究者
Seth W. Gregory
Principal Investigator
Mayo Clinic