跳至主要内容
临床试验/NCT07167394
NCT07167394Enrolling By Invitation不适用

The Effect of Presenting Restorative Dental Treatments in a Game Format Using Virtual Reality Glasses on Anxiety and Pain Perception in Children

Ankara University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
88
试验地点
1
主要终点
State-Trait Anxiety Inventory for Children - Dental Version

研究概览

简要总结

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence.

On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future.

This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures.

A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique.

In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety.

In the other group, behavior management will be provided using the tell-show-do method. This includes explaining procedures using child-friendly language (tell), demonstrating non-threatening aspects of the instruments and environment (show), and performing the procedures accordingly (do).

After informed consent is obtained, the treating dentist will select teeth based on clinical and radiographic criteria. Dento-alveolar images will be reviewed using VR glasses and explained to the parent, who will also wear VR glasses for an immersive consultation experience. A caries detection tool powered by artificial intelligence will support diagnosis.

Treatments will be performed on the lower primary molars with mesio-occlusal or disto-occlusal caries not involving the pulp.

Pain perception and anxiety will be evaluated using psychometric scales (SCARED, CFSS-DS, Wong-Baker, STAIC) and physiological measurements (pulse oximeter, heart rate) at standardized intervals: before, during, and after treatment.

It is hypothesized that the VR-based game will result in lower anxiety and pain perception, greater cooperation, and more positive dental experiences compared to the tell-show-do method.

详细描述

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence.

On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future.

This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures.

A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique.

In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Although the intervention is not blinded to participants or care providers due to the visible nature of the VR headset and behavioral techniques, the individuals evaluating outcome measures (such as anxiety and pain scores) are blinded to group assignment. Self-reported scales are collected by an independent researcher not involved in the intervention delivery. Additionally, the data analysis will be conducted using anonymized group labels (Arm 1 / Arm 2), ensuring that the statistician remains blinded to group allocation.

入排标准

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

入选标准

  • •Children aged 6 to 10 years
  • •No previous dental treatment history
  • •No systemic or chronic medical conditions
  • •No mental retardation
  • •No psychiatric pathology based on CBCL, K-SADS-PL-T, and SCARED (SCARED score <25)
  • •Presence of dentin caries on mandibular molars (mesio-occlusal or disto-occlusal)
  • •Signed informed consent by parent/Guardian

排除标准

  • •Prior dental treatment experience
  • •SCARED score ≥25
  • •Diagnosed psychological or developmental disorders
  • •Acute dental pain or irreversible pulp involvement
  • •Decline to sign informed consent

研究组 & 干预措施

Virtual Reality Game Group

Experimental

Children in this group will receive restorative dental treatment following a virtual reality-based animated educational game presented via VR headset. The game introduces each treatment step in a child-friendly narrative to reduce anxiety and perceived pain.

干预措施: Interactive Virtual Reality Guidance with Restorative Dental Treatment (Procedure)

Tell-Show-Do Group

Experimental

Children in this group will receive the same restorative dental treatment after conventional behavioral preparation using the Tell-Show-Do technique, where each procedure is verbally explained and visually demonstrated prior to treatment.

干预措施: Tell-Show-Do Guidance with Restorative Dental Treatment (Procedure)

结局指标

主要结局

State-Trait Anxiety Inventory for Children - Dental Version

时间窗: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.

Description: A validated self-report questionnaire used to evaluate children's state and trait anxiety levels in dental settings. Score Range: 20 to 60 for each subscale (State and Trait). Interpretation: Higher scores indicate greater anxiety levels.

SCARED (Screen for Child Anxiety Related Emotional Disorders)

时间窗: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.

Description: A validated self-report tool assessing symptoms of anxiety disorders in children. Score Range: 0 to 82. Interpretation: Higher scores reflect greater anxiety. Scores ≥25 suggest clinically significant anxiety.

Pulse Rate Monitoring via Pulse Oximeter

时间窗: T1: Baseline - before the patient is seated in the dental chair. T2: During local anesthesia administration. T3: During the restorative treatment. T4: Within 5 minutes after completion of the treatment.

Description: Objective physiological measurement of heart rate used as an indicator of anxiety. Pulse rate will be recorded at multiple standardized time points. Score Range: Beats per minute (bpm); continuous numerical data. Interpretation: Higher pulse rates are associated with increased physiological anxiety.

Wong-Baker Faces Pain Rating Scale

时间窗: Time Frame: After local anesthesia administration and within 20 minutes after the end of the restorative treatment for each arm.

Description: A self-assessment scale where children rate their pain using illustrated facial expressions. Score Range: 0 to 10. Interpretation: Higher scores represent greater perceived pain.

Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)

时间窗: Time Frame: Within 20 minutes after the end of the restorative treatment for each arm.

Description: Standardized questionnaire evaluating children's dental-specific fears. Score Range: 15 to 75. Interpretation: Higher scores indicate higher dental fear. A score \>38 is typically considered high.

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

Levent Özer

professor

Ankara University

研究点 (1)

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