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临床试验/NCT04346732
NCT04346732已完成不适用

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

Saglik Bilimleri Universitesi0 个研究点目标入组 88 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
主要终点
Change from baseline in venipuncture pain on the Visual Analogue Scale(VAS) during blood donation

研究概览

简要总结

Aim: The aim of this study is to assess the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors.

Hypotheses:

H1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray does not reduce venipuncture pain during blood donation.

详细描述

After being informed about the study and potential risks, all patients giving written informed consent. Before the procedure was begun, the donors who agreed to participate in the study were met face-to-face and asked to fill in the "Informative Characteristics Form", the "VAS", the "Blood/Injection Fear Scale" and the "STAI-I" forms.Then the donors were assigned to their groups by the researcher.The donors in the control group were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group. During the blood collection procedure, after the donors' skin was cleaned with antiseptic solution, spray was applied to the application site for a maximum of 10-15 seconds from a distance of 25 cm. In both groups, immediately following venipuncture, pain assessment was made with the VAS by the researcher, who did not know which group each participant belonged to.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

In both groups, immediately following venipuncture, pain assessment was made with the VAS by the researcher, who did not know which group each participant belonged to.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • aged between 18 and 35
  • BMI between 18.5 and 24.9 kg/m2
  • speaks turkish
  • male donor
  • individuals who applied to make voluntary blood donations
  • volunteers to participate in the study

排除标准

  • donors who did not agree to take part in the study,
  • donors with open wound, scar, infection, dermatitis, eczema or lesion at the venipuncture site, or donors with cold allergy

结局指标

主要结局

Change from baseline in venipuncture pain on the Visual Analogue Scale(VAS) during blood donation

时间窗: immediately following venipuncture procedure

The VAS is used to inquire about pain levels resulting from venipuncture.In the 10 cm-long VAS, 0 indicates no pain, while 10 indicates the most intense pain.

次要结局

未报告次要终点

研究者

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

Semra Aciksoz

Assistant Professor

Saglik Bilimleri Universitesi

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