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临床试验/NCT04950478
NCT04950478已完成不适用

THE EFFECT OF VIRTUAL REALITY ON PAIN EXPERIENCED BY SCHOOL-AGE CHILDREN DURING VENIPUNCTURE: RANDOMIZED CONTROLLED STUDY

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018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
发起方
入组人数
102
试验地点
2
主要终点
Pain Severity

研究概览

简要总结

This study is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level, heart rate and oxygen saturation values among 7-12 year-old children. The data were collected from 102 children coming to vaccination room of an university hospital's pediatric outpatient clinic. Before the venipuncture, state anxiety scores of children in both groups were evaluated. The children in experimental group wore virtual reality headset during the venipuncture. The children in control group were subjected to standard venipuncture procedure. Before, during and after the venipuncture, pulse and oxygen saturation values were measured.

详细描述

The research was designed as a randomized controlled experimental study. The population of the study consisted of all 7-12 year-old children who came to a vaccination room of an university hospital's pediatric outpatient clinic .It is stated in the literature that the sample size should be determined as minimum 41 in both experimental and control groups in the experimental studies.

In the study, randomization Urn method was carried out. Urn method consists of two parameters (α and β). These parameters are matched with two different colored balls (red and white). One of the balls was randomly selected and if this ball was white, the individual was assigned to α group; if it was red, then participant was assigned to β group. This process was repeated for each assignment. In the study, white ball was determined as control group; whereas, red ball was determined as experimental group. In the case of a child meeting the sampling criteria, these balls that the researcher had previously prepared were placed in a black bag and any nurse working in the pediatrics outpatient clinic at that time was asked to draw a ball from the bag. The children were assigned to experimental or control group based on color of the selected ball so that they were randomly distributed to two groups. A total of 106 children including 54 children in the experimental group and 52 children in the control group were included in the sample group by taking possible case losses into account. Since 2 children in the experimental group did not want to wear the virtual reality headset during the procedure, they were excluded from the sample. 2 children in the control group were excluded from the sample because venipuncture procedure did not take place at once. Thus, the sample group consisted of 102 children in total including 52 children in the experimental group and 50 children in the control group. The study followed the CONSORT guideline for reporting randomized controlled trials. The data collection questionnaries included a Child and Parent Information Form, State-Trait Anxiety Inventory for Children, and Faces Pain Scale-Revised (FPS-R).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Children aged 7-12 who agreed to participate in the study by giving written and verbal consent,
  • Parents who agreed to participate in the study verbally and in written by signing informed consent form,
  • Body temperature within normal values for children (36.5- 37.2 oC),
  • Children who were healthy and for whom the doctor requested a blood test for general control.
  • Children who were healthy in sensory and neurologic aspects.

排除标准

  • Having any chronic disease or any disease causing pain in children,
  • Having hearing, mental or neurological disability in children,
  • Having history of syncope during previous venipuncture procedures for the children,
  • Having visual impairment in children,
  • Unsuccessful venipuncture procedure in the first attempt.

结局指标

主要结局

Pain Severity

时间窗: Between 5-10 minutes

The children were informed about the Faces Pain Scale-Revised (FPS-R) and they were asked to mark the children's pain levels on the scale before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.

次要结局

  • Heart Rate(Between 5-10 minutes)
  • Oxygen Saturation(Between 5-10 minutes)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Orhan

PhD RN, Educator Nurse

Koc University Hospital

研究点 (2)

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