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临床试验/NCT06243419
NCT06243419已完成不适用

The Effect Of Vein Imaging Device And Virtual Reality On Catheter Intervention Success, Procedure Related Outcomes During Peripheral Intravenous Catheterization in Children

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年5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
160
试验地点
2
主要终点
Emotional Appearance by Emotional Appearance Scale for Children

研究概览

简要总结

The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.

详细描述

The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.

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
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of 4-10
  • The child agrees to voluntarily participate in the study.
  • Parents agree to voluntarily participate in the study
  • Obtaining consent from the child and parent

排除标准

  • Need for urgent resuscitation
  • Having a fever (>37.5C) and severe dehydration
  • The fact that the patient had taken analgesics before the PIC intervention.

结局指标

主要结局

Emotional Appearance by Emotional Appearance Scale for Children

时间窗: before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]

This scale allows direct behavioral observation, and consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represent the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. A higher scale score indicates the appearance of more negative emotional behaviors.

Pain assesed by Wong-Baker FACES

时间窗: immediately after the vascular access (on average 2-3 minutes later)

Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.

Anxiety assesed by Children Anxiety Meter-State

时间窗: immediately after the vascular access (on average 2-3 minutes later)

The Children's Anxiety Meter. The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). higher scores mean a worse outcome.

Fear assesed by Child Fear Scale

时间窗: immediately after the vascular access (on average 2-3 minutes later)

The Child Fear Scale. This one-item scale measures procedure-related fear in children, consisting of five sex-neutral faces ranging from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no-fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome.

the success of peripheral intravenous catheter (PIC) placement

时间窗: at PIC insertion

first IV attempt

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

Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Dokuz Eylul University

研究点 (2)

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