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Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children

2026年11月4日 更新者:Didem ATABEK

Comparison of "Virtual Reality" (VR) and "Point-of-View" (POV) Video Modeling Techniques for Reducing Dental Anxiety in Children

Dental anxiety is common among children and may make dental treatment more difficult. This study aims to compare three non-pharmacological behavior guidance techniques for reducing dental anxiety and improving cooperation during invasive fissure sealant treatment in children aged 6-10 years.

Children who require an invasive fissure sealant on a mandibular first molar and meet the study eligibility criteria will be included. Participants will be randomly assigned to one of three groups. The first group will watch a 1.5-2-minute Point-of-View (POV) video showing the dental examination and treatment process from a child's perspective before the dental procedure. The second group will use virtual reality (VR) glasses during the procedure and watch age-appropriate animation or cartoon content as an active distraction technique. The control group will receive the standard Tell-Show-Do behavior guidance technique.

Dental anxiety, behavior, physiological responses, and pain will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Facial Image Scale (FIS), Frankl Behavior Rating Scale, pulse rate, oxygen saturation, and Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to assess the children's experiences with the behavior guidance techniques.

The study is expected to provide comparative evidence regarding the effectiveness of POV video modeling and VR distraction compared with the standard Tell-Show-Do technique in managing dental anxiety and improving children's cooperation during dental treatment.

研究概览

详细说明

The Facial Image Scale (FIS) will be used to evaluate the child's anxiety at four predefined time points: while the child is waiting in the waiting area, after sitting in the dental unit before the behavior guidance technique, after application of the assigned behavior guidance technique, and after completion of the invasive fissure sealant procedure.

Pulse rate and oxygen saturation will also be recorded at the same four assessment time points using a pulse oximeter. The Frankl Behavior Rating Scale will be used to assess behavioral cooperation before and during the dental procedure. Immediately after completion of the invasive fissure sealant procedure, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to evaluate the child's experience and perceived comfort with the assigned behavior guidance technique.

研究类型

介入性

注册 (估计的)

69

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 10年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children aged 6-10 years.
  • Children without any systemic or psychiatric disorder or special needs.
  • Children who do not require emergency dental treatment.
  • Children whose parent(s) provide written and/or verbal informed consent for participation in the study.
  • Children who agree to participate in the assigned intervention, including watching the POV video or using virtual reality (VR) glasses, as applicable.

Exclusion Criteria:

  • Children with a systemic or psychiatric disorder or special needs.
  • Children who require emergency dental treatment.
  • Children who refuse to use virtual reality (VR) glasses.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:POV Video Modeling Group

Participants in this group will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is designed to familiarize the child with the dental procedure before invasive fissure sealant treatment.

Participants will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is intended to familiarize the child with the dental procedure before invasive fissure sealant treatment.

实验性的:Virtual Reality (VR) Group

Participants in this group will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment.

Participants will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment.

有源比较器:Tell-Show-Do Control Group

Participants in this group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach.

Participants in the control group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Facial Image Scale (FIS) Score
大体时间:Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.

The Facial Image Scale (FIS) is a self-report measure used to assess dental anxiety in children. It consists of five facial images representing increasing levels of anxiety, scored from 1 to 5. A score of 1 indicates the least anxiety, whereas a score of 5 indicates the highest anxiety. Higher scores indicate greater dental anxiety and therefore a worse outcome.

FIS scores will be recorded at five time points. During the first visit, the FIS will be administered within 1 minute after completion of the dental examination. During the second visit, which will take place 2 weeks after the initial visit, FIS scores will be recorded at four time points: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure.

Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.

次要结果测量

结果测量
措施说明
大体时间
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
大体时间:Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.

Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), a 15-item scale scored from 15 to 75. Higher scores indicate greater dental fear and anxiety and a worse outcome. Scores are categorized as low (≤32), moderate (33-37), and high (≥38) dental anxiety. CFSS-DS scores will be recorded within 5 minutes after completion of the dental examination during the first visit and within 5 minutes after completion of the fissure sealant procedure during the second visit, which will take place 2 weeks after the initial visit.

Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.
Frankl Behavior Rating Scale Score
大体时间:Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.

The child's behavior will be assessed using the Frankl Behavior Rating Scale, which consists of four categories scored from 1 to 4: definitely negative (1), negative (2), positive (3), and definitely positive (4). Higher scores indicate more positive behavior and a better outcome.The child's behavior will be observed during the dental examination at the first visit and, at the second visit, during the dental examination before the behavior guidance technique and throughout the fissure sealant procedure, including at treatment completion. The second visit will take place 2 weeks after the initial visit.

Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.
Pulse Rate
大体时间:Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.

Pulse rate (beats per minute, bpm) will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure.

Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
Oxygen Saturation (SpO2)
大体时间:Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.

Oxygen saturation (SpO₂), expressed as a percentage (%), will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure. Changes in SpO₂ will be evaluated across these time points.

Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
Wong-Baker FACES Pain Rating Scale Score
大体时间:Visit 2: Within 1 min after completion of the fissure sealant procedure.

Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, scored from 0 to 10 in increments of 2 (0, 2, 4, 6, 8, and 10). A score of 0 indicates no pain, while 10 indicates the worst pain. Higher scores indicate greater pain intensity and a worse outcome. Pain will be assessed within 1 minute after completion of the invasive fissure sealant procedure during the second visit.

Visit 2: Within 1 min after completion of the fissure sealant procedure.
Satisfaction and Experience Questionnaire
大体时间:Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).

A post-intervention Satisfaction and Experience Questionnaire will be administered to participants in the POV Video Modeling and Virtual Reality (VR) groups within 5 minutes after completion of the fissure sealant procedure to assess their satisfaction, perceptions, and comfort regarding the assigned behavior guidance technique. Items will be answered with "Yes" or "No."

Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

调查人员

  • 首席研究员:Didem Atabek, Prof. Dr.、Gazi University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月20日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年10月19日

首先提交符合 QC 标准的

2026年10月19日

首次发布 (实际的)

2026年10月26日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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