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临床试验/NCT02937428
NCT02937428Unknown3 期

To Look or Not to Look? Pilot Study of the Effectiveness of a Simple Psychological Intervention in Reducing Vaccination Pain and Fear in Adult

University of Toronto2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
3 期
入组人数
160
试验地点
2
主要终点
Pain

研究概览

简要总结

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by research evidence. the purpose of this study is to learn about how looking away vs. looking at the needle during vaccination makes people feel. People will be randomized to 1 of 2 groups: look at the needle, look away. Then they will undergo vaccination and report on pain and fear experienced.

详细描述

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by experimental research evidence. It is possible that looking away acts as a distraction and takes attention away from the needle, thus reducing pain. However, it is also possible that looking at the needle is better because it prevents people's imaginations from making them think it is worse than it actually is. To our knowledge, this is the first first randomized study to examine the effect of looking away vs. looking at the needle on pain and fear experienced during vaccinations. Adult university students undergoing routine flu vaccination will be included.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination

排除标准

  • less than 18 years of age or prior participation in the trial

结局指标

主要结局

Pain

时间窗: immediately after vaccination (<5 minutes)

self-reported pain assessed after vaccination using a numerical rating scale (0-10)

Fear

时间窗: immediately after vaccination (<5 minutes)

self-reported fear assessed after vaccination using a numerical rating scale (0-10)

次要结局

  • Preferences of participants(immediately after vaccination (<5 minutes))
  • Recruitment rate(before vaccination (1 day to 4 weeks))
  • Attrition of participants(immediately after vaccination)
  • Feasibility of recruitment of subjects in the 2 study strata (i.e., preference to look or not look)(immediately before vaccination (<5 minutes))
  • Duration of appointment(immediately after vaccination)
  • Fidelity of intervention(During vaccination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Taddio

Professor

University of Toronto

研究点 (2)

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