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临床试验/NCT07261410
NCT07261410已完成不适用

Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety During Venipuncture

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
procedure related emotional apperance

研究概览

简要总结

This study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture.

详细描述

Participants were assigned to three groups through stratified randomization: the active VR, the passive VR, and the control group. Children in the VR groups wore VR goggles (Oculus Quest 2) during venipuncture.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •The child agrees to participate in the study voluntarily.
  • •The parent agrees to participate in the study voluntarily.
  • •Obtaining consent forms from the child and parent

排除标准

  • •The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
  • •Having fever (>37.5C) and severe dehydration
  • •The patient did not take analgesics before the intervention

研究组 & 干预措施

Control

No Intervention

Standart care

Active VR

Experimental

The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications.

干预措施: active VR distraction (Device)

Passive VR

Experimental

It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application with Oculus Guest 2 that will attract the attention of children was determined by the researchers.

干预措施: passive VR distraction (Device)

结局指标

主要结局

procedure related emotional apperance

时间窗: immediately after the phlebotomy

This scale allows direct behavioral observation, 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 represents 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. Higher scale score indicates the appearance of more negative emotional behaviors

procedure related pain

时间窗: 3 minutes after the phlebotomy

Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).

procedure related anxiety

时间窗: 3 minutes after the phlebotomy

The Children's Anxiety Meter (CAM-S). 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). This scale ranges from 0 to 10. Higher values represent higher anxiety

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

Proffesor, Pediatric Nursing Department

Dokuz Eylul University

研究点 (1)

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