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临床试验/NCT04824690
NCT04824690已完成不适用

The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年3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
70
试验地点
2
主要终点
Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)

研究概览

简要总结

An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

详细描述

Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 4-10 years old
  • ASA grade I or II
  • General anesthesia
  • Elective surgery

排除标准

  • Children who have had previous surgery history
  • Local anesthesia or emergency surgeries
  • Premature or congenital disease history
  • Having visual and hearing impairment
  • Mental and developmental retardation
  • Having a history of epilepsy and seizures
  • Patients taking psychoactive drugs

结局指标

主要结局

Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)

时间窗: This is measured right before the child goes into operating theatre / separating from his/her parents.

The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 \& Max score : 10

次要结局

  • Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale(This is measured immediately after the intervention.)
  • Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)(This is measured immediately after the surgery.)
  • Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale(This is measured immediately after the surgery.)

研究者

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

Aykut Turgut

Research Assistant

Abant Izzet Baysal University

研究点 (2)

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