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Effective Analgesia During Routine Immunizations

2015年7月28日 更新者:John Harrington、Children's Hospital of The King's Daughters

Effective Analgesia Using the 5 S's During Routine Immunizations at 2 and 4 Months

The purpose of this study is to observe and measure the 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.

研究概览

地位

完全的

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:

  1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after Immunization (Control Group)
  2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or guardian after immunization (Sucrose Group)
  3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical Group)
  4. 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

观察性的

注册 (实际的)

230

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Norfolk、Virginia、美国、23507
        • Children's Hospital of the King's Daughters

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2个月 至 4个月 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

All patients were enrolled from the General Academic Pediatric outpatient practice located at The Children's Hospital of The King's Daughters in Norfolk, VA. This practice serves a predominantly urban, Medicaid enrolled, African-American population and has approximately 30,000 annual visits per year.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
control
water and normal physical comfort provided by mom
sucrose
sugar and normal physical comfort provided by mom
physical intervention
physical intervention using the 5 S's and water
physical intervention and sucrose
Physical intervention using the 5 S's and sugar water

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2010年9月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2011年6月3日

首先提交符合 QC 标准的

2011年6月7日

首次发布 (估计)

2011年6月8日

研究记录更新

最后更新发布 (估计)

2015年7月29日

上次提交的符合 QC 标准的更新

2015年7月28日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • EVMS

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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