ACTRN12618001645246已完成未知
A safety and exploratory efficacy pilot study of NeedleCalm™ in reducing pain and needle sensation in a venepuncture procedure: a single group, single-blinded, randomised placebo-controlled investigation in healthy volunteers.
eedlecalm Pty Ltd0 个研究点目标入组 12 人开始时间: 2018年10月4日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1)Participants between 18 and 60 years of age at time of entry on study;
- •2)Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
- •3)Participants agree to undergo a venepuncture procedure once per procedure in the cubital fossa of the dominant arm and have 5 ml of blood collected; (i.e 10ml of blood will be collected).
- •4)Participants agree to adhere to the study protocol;
- •5)No history of illicit intravenous drug use;
- •6)No history of needle-phobia (trypanophobia);
- •7)No history of any chronic diseases.
排除标准
- •1)Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, medical history, clinical chemistry, haematology, urinalysis, vital signs;
- •2)Current or previous allergies or allergic responses to latex;
- •3)Current use of any intravenously administered, prescribed or illicit drugs;
- •4)Any history of moderate to severe needle-phobia (trypanophobia);
- •5)Pregnant or nursing an infant;
- •6)Any psychiatric disorders by history or examination that would prevent completion of the venepuncture procedure or result in possible adverse events for the participant;
- •7)The current use of any prescribed or over the counter analgesia (7 days wash-out period required);
- •8)Not have received more than two needle procedures in the past 12 months.
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