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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 University1 个研究点 分布在 1 个国家目标入组 70 人2019年4月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pain, Procedural
发起方
Nevsehir Haci Bektas Veli University
入组人数
70
试验地点
1
主要终点
Visual Analog Scale (VAS), Change:
状态
已完成
最后更新
4年前

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.

注册库
clinicaltrials.gov
开始日期
2019年4月29日
结束日期
2019年8月31日
最后更新
4年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Nevsehir Haci Bektas Veli University
责任方
Principal Investigator
主要研究者

Bahriye Kaplan

Principal Investigator

Nevsehir Haci Bektas Veli University

入排标准

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)

研究点 (1)

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