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临床试验/NCT05955755
NCT05955755已完成不适用

The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle Used in Blood Collection in Children on the Level of Pain and Fear: A Randomized Controlled Study

Firat University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2023年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Numerical Pain Scale

研究概览

简要总结

This study was planned to examine the effects of the butterfly vacuum blood collection set and standard vacutanier needle used during blood collection in children on the level of pain and fear. It is a randomized controlled trial.The study will be conducted in the pediatric blood collection unit with children between the ages of 7 and 12 who have undergone blood tests by a pediatrician.Data collection tools: "Descriptive Information Form", "Difficult Intravenous Intervention Score" for Children, "Numerical Pain Scale", "Child Fear Scale" will be used to collect data.The data will be uploaded to the computer and coded by the researchers, and the data will be evaluated in the SPSS package program. The sociodemographic data of the children participating in the study will be given as numbers and percentage distributions. Appropriate tests will be used by analyzing the data for normal distribution. The statistical significance level of the study was determined as p< 0.05. In addition, at the end of the research, the status of working with sufficient sample size will be tested with post-hoc power analysis.

详细描述

Purpose of the study: This study was planned to examine the effects of the butterfly vacuum blood collection set and standard vacutanier needle used during blood collection in children on the level of pain and fear.

Type of Study: It is a randomized controlled study. Location and Characteristics of the Study: It will be conducted in the pediatric blood collection unit of Fırat University Hospital, with children aged 7-12 who are subjected to blood tests by a pediatrician.

Population-Sample: The population of the study will consist of children who applied for blood collection in the pediatric blood collection unit of Fırat University Hospital. A pilot study will be conducted to determine the number of samples. For the pilot study, 20 participants will be taken from each group and a total of 40 samples will be taken. As a result of the pilot study, power analysis will be performed and the number of samples will be determined. Randomization will be done to assign the participants to the groups. Grouping will be done using simple random sampling. Randomization will be provided using the Random Sequence Generator on the www.random.org website. Each participant who volunteers to participate in the study and meets the criteria will be given a number. Accordingly, which number will take place in which group will be determined in advance.

Data collection tools: "Descriptive Information Form", "Difficult Intravenous Intervention Score" for Children, "Numerical Pain Scale", "Child Fear Scale" will be used to collect data.

Data Collection: Data collection Children who accept to participate in the 1st stage study will be given the Difficult Intravenous Intervention Score for Children.

研究设计

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

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 7-12
  • Do not have a chronic disease
  • Peripheral intravenous catheter (PIC) application by the same nurse (with at least 5 years of experience)
  • Able to express oneself verbally
  • No visual and auditory problems
  • Forced intravenous access score below 4

排除标准

  • Children treated with tropical anesthetic before the procedure
  • Children who have taken analgesics in the last 6 hours
  • Neurodevelopmentally delayed children
  • Children with chronic disease
  • Children with unsuccessful blood draw attempts

结局指标

主要结局

Numerical Pain Scale

时间窗: 1 day

This method, which is aimed at determining the severity of pain, aims to explain the patient's pain in numbers. Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.

次要结局

未报告次要终点

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Selime MERTER

ASSISTANT PROFESSOR

Firat University

研究点 (2)

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