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临床试验/NCT06527092
NCT06527092已完成不适用

The Effect of Virtual Reality on Pain, Anxiety And Fear During Venipuncture in Children Aged 6-12 Years: A Randomised Controlled Trial

Ege University2 个研究点 分布在 2 个国家目标入组 105 人开始时间: 2023年1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
105
试验地点
2
主要终点
Procedurel Pain

研究概览

简要总结

The use of non-pharmacological applications such as virtual reality,and bubbles are recommended in intravenous interventions. There are very few studies evaluating the effect of non-pharmacological applications in intravenous localization. This study was planned as a randomized controlled trial. The effects of virtual reality and bubble application on pain, fear, anxiety, procedure time and crying time in intravenous insertion were evaluated. Children (105) aged 6-12 years who were treated in a children's hospital and underwent intravenous placement were randomized to virtual reality, bubbles, and control groups. Distraction techniques such as asking questions and talking were used with the children in the control group. Study data were collected using the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale, and Visual Analogue Scales (VAS).

详细描述

The use of non-pharmacological applications such as virtual reality, and bubbles are recommended in intravenous interventions. There are very few studies evaluating the effect of non-pharmacological applications in intravenous localization. This study was planned as a randomized controlled trial. The effects of virtual reality and bubble application on pain, fear, anxiety, procedure time, and crying time in intravenous insertion were evaluated. Children (105) aged 6-12 years who were treated in a children's hospital and underwent intravenous placement were randomized to virtual reality, bubbles, and control groups. Distraction techniques such as asking questions and talking were used with the children in the control group. Study data were collected using the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale, and Visual Analogue Scales (VAS).

Virtual reality: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale-Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. The child was fitted with virtual reality goggles and a video of the child's choice was shown. One of the videos was a video of visiting animals in the zoo, while the other video was an aquarium video containing colorful fish and creatures under the sea. The zoo visit video is 3 minutes 51 seconds and the aquarium visit video is 11 minutes 55 seconds. Two minutes after the child started watching the video, peripheral catheter insertion was started. During the procedure, the same nurse, who was independent of the study, assessed the child with the Child Anxiety Scale-Condition(CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the child's crying (how many seconds it lasted)

Bubbles: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale-Condition(CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. The child was given a colorful, lighted bubble gun. Two minutes after the child used the colored-light bubble gun, peripheral catheter insertion was started. During the procedure, the same nurse, who was independent of the study, assessed the child with the Child Anxiety Scale-Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the child's crying (how many seconds it lasted).

Control: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale- Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. Peripheral catheter insertion was started. Distraction techniques such as asking questions and talking were used during the procedure. During the procedure, the same nurse, who was independent of the study, evaluated with the Child Anxiety Scale- Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the crying status of the child (how many seconds it lasted).

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • The child was treated at the Ege University Medical Faculty Children's Hospital, Between the ages of 6 and 12, Peripheral catheter insertion Both parents and themselves speak and understand Turkish, and It was determined as volunteering to participate in the study.

排除标准

  • Children under 6 years of age or over 12 years of age Children treated with analgesics Sedated children

结局指标

主要结局

Procedurel Pain

时间窗: Six month

Visual Analogue Scale (VAS): Recommended for use in children aged 7 years and over. The child is asked to mark the level of pain felt on a 10 cm ruler in the range from '0 - no pain' to '10 - most severe pain'. The scale can be used either horizontally or vertically.

Anxiety

时间窗: Six month

Child Anxiety Scale-Condition (CAS-D):The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. The score can range from 0 to 10. Turkish validity and reliability have been performed.

Fear

时间窗: Six month

Child Fear Scale:The scale is used to measure the fear level of the child. It is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). Turkish validity and reliability have been performed.

次要结局

  • duration of crying(Six month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Zengin

Asst. Prof.

Ege University

研究点 (2)

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