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临床试验/NCT06315816
NCT06315816已完成不适用

The Effect of Virtual Reality Glasses Used During Tooth Extraction and Extirpation Treatment Under Local Anesthesia on Anxiety and Fear in 7-10 Years Old Children

Murat Bektaş1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4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
发起方
入组人数
120
试验地点
1
主要终点
Anxiety Means

研究概览

简要总结

This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

详细描述

Aims and Objectives: Virtual reality glasses can be used as a distraction method in dental practices for children. This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

Design: A randomized controlled experimental study design will use. Methods: The sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. Data collection tools included a Child and Family Information Form, the Children's Fear Scale, and the Child Anxiety Scale-State. During the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. No intervention will apply to the control group. Data will analyz using the Chi-square test, t-test, Shapiro-Wilk, mean, and percentage distributions.

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
Single (Outcomes Assessor)

盲法说明

The data will be analyzed by a statistician blind to the groups.

入排标准

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

入选标准

  • Children who will between the ages of 7-10,
  • Children who have Tooth Extraction
  • Children who have Extirpation Treatment
  • Have no cognitive development problems,

排除标准

  • Children who will not want to participate in the study,
  • Leave the research during the study,
  • Have an audio-visual disorder that could prevent the use of virtual glasses.

研究组 & 干预措施

Experimantal

Experimental

The children will ask to choose a three-dimensional cartoon from the list to watch during the procedure, it will run, the mobile phone will placed into the virtual reality glasses, and the children wear the VR glasses and start watching the cartoon. During the procedure, the children's parents and the researcher will present, and the children watch the cartoon through virtual reality glasses. After the procedure, the virtual reality glasses will removed, and ten minutes after the procedure will completed, the CFS and the CAS-S will apply as a post-test.

干预措施: virtual reality glasses used during tooth extraction and extirpation treatment (Behavioral)

Control

No Intervention

No intervention

结局指标

主要结局

Anxiety Means

时间窗: 1-4 Weeks

Anxiety score will be measured with the Child Fear and Anxiety Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's anxiety increases. In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety. Getting a low score from the scale will indicate that their anxiety about the procedure is low.

Fear Means

时间窗: 1-4 Weeks

Fear score will be measured with the Children's fear and anxiety scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's fear increases. In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high. A low score on the scale will indicate that fears about the procedure are low.

次要结局

未报告次要终点

研究者

发起方
Murat Bektaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Murat Bektaş

Head of Department

Dokuz Eylul University

研究点 (1)

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