Effective Analgesia During Routine Immunizations
Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months
研究概览
地位
条件
详细说明
Study Procedure
Infants meeting inclusion criteria were identified daily by reviewing the list of patients scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal guardian was approached prior to vaccination by the research assistant for participation in the study. If the parent/guardian accepted to participate in the vaccine study, the consenting process was performed and patients were brought to a designated examination room. Infants of parents or guardians who consented were randomly assigned to one of four study groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40 cards, which were recycled with each group of 40 infants enrolled into the study. The four groups of the study included:
- 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after Immunization (Control Group)
- 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or guardian after immunization (Sucrose Group)
- 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical Group)
- 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical and Sucrose Group)
研究类型
注册 (实际的)
联系人和位置
学习地点
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Virginia
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Norfolk、Virginia、美国、23507
- Children's Hospital of the King's Daughters
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- infants with a gestational age between 32-42 weeks at delivery and post-natal age of less than 20 weeks old
Exclusion Criteria:
- acetaminophen or ibuprofen administration within 4 hours prior to immunization, current neurological disorder, known genetic anomaly, moderate to severe illness with or without fever at the time of vaccination, anaphylactic reaction to previous dose of vaccine, or if infant was previously enrolled in the study at 2 months.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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control
water and normal physical comfort provided by mom
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sucrose
sugar and normal physical comfort provided by mom
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physical intervention
physical intervention using the 5 S's and water
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physical intervention and sucrose
Physical intervention using the 5 S's and sugar water
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits.
大体时间:every 15 sec
|
Does the 5 S's improve the percieved pain of infants receiving vaccinations.
The Modified Riley Pain Scale which measure 3 aspects of pain was utilized.
The scale is validated for the assessment of acute pain in preterm and term infants.
|
every 15 sec
|
合作者和调查者
调查人员
- 首席研究员:John W Harrington, MD、Children's Hospital of the King's Daughters
出版物和有用的链接
一般刊物
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- Ornstein PA, Manning EL, Pelphrey KA. Children's memory for pain. J Dev Behav Pediatr. 1999 Aug;20(4):262-77. doi: 10.1097/00004703-199908000-00009.
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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