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临床试验/NCT05273866
NCT05273866已完成不适用

A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study

Nevsehir Haci Bektas Veli University2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2019年4月29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
70
试验地点
2
主要终点
Visual Analog Scale (VAS), Change:

研究概览

简要总结

This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.

详细描述

This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of <0.05 was considered statistically significant in data analysis.

研究设计

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

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,
  • Does not have a disease that causes chronic pain,
  • Not taking any analgesic medication in the last 8 hours before the procedure,
  • No mental or neurological disability,
  • Having no visual or auditory problems that prevent you from applying the scales or watching videos,
  • Does not have eye problems and/or does not use glasses to be able to wear VR glasses,
  • The first vascular access procedure was performed during this hospitalization at the clinic,
  • Vascular access opened on the first try,
  • Speaking and understanding Turkish,
  • Children whose parents and themselves agreed to participate in the study were included in the study.

排除标准

  • Does not understand the Turkish language
  • the child is under 7 years old or 12 years older
  • having vision, hearing or speech problems
  • having a mental or neurological disability

结局指标

主要结局

Visual Analog Scale (VAS), Change:

时间窗: 2 minutes before and 2 minutes after Intravenous Cannulatıon

The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.

Faces Pain Scale-Revised (FPS-R), Change:

时间窗: 3 minutes before and 3 minutes after Intravenous Cannulatıon

In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.

次要结局

  • Physiological parameters(3 minutes before and 3 minutes after Intravenous Cannulatıon)

研究者

发起方
Nevsehir Haci Bektas Veli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahriye Kaplan

Principal Investigator

Nevsehir Haci Bektas Veli University

研究点 (2)

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