A Clinical Study Comparing Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety and Pain Control During Local Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change in Dental Anxiety Level During Local Anesthesia
研究概览
简要总结
Dental anxiety is a common problem in children and may negatively affect cooperation, pain perception, and treatment success during dental procedures. Distraction techniques are widely used to reduce anxiety during dental treatment. In recent years, virtual reality (VR) and mixed reality (MR) technologies have been introduced as innovative audiovisual distraction methods in pediatric dentistry.
The aim of this randomized clinical study is to compare the effects of virtual reality and mixed reality head-mounted displays on dental anxiety and pain perception in children during local anesthesia administration. A total of 142 systemically healthy children aged 6 to 12 years who required dental treatment under local anesthesia were included. Participants were randomly assigned to either a VR group or an MR group.
Dental anxiety and pain levels were assessed using validated scales before and during local anesthesia administration. Behavioral responses and physiological parameters were also recorded. The results of this study will help determine whether VR or MR provides superior anxiety control during pediatric dental procedures.
详细描述
Dental anxiety in children is associated with increased pain perception, behavioral problems, and reduced treatment compliance. Managing anxiety during dental procedures is therefore a critical component of pediatric dental care. Conventional behavior guidance techniques may not always be sufficient, particularly during invasive procedures such as local anesthesia administration.
This randomized, parallel-group clinical trial was conducted to compare the effects of virtual reality (VR) and mixed reality (MR) head-mounted displays on dental anxiety and pain perception in pediatric patients. The study included 142 systemically healthy children aged between 6 and 12 years who required dental treatment under local anesthesia. Only children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale were included.
Participants were randomly allocated into two groups: a VR group and an MR group. During local anesthesia administration, children in the VR group were exposed to a fully immersive virtual environment, while children in the MR group interacted with virtual content while maintaining partial awareness of the clinical environment.
Dental anxiety was evaluated using the Children's Fear Survey Schedule-Dental Subscale, and pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. Behavioral pain responses during local anesthesia were scored using the FLACC scale by two independent observers. Heart rate measurements were recorded as a physiological indicator of anxiety. Interobserver reliability for behavioral assessments was also evaluated.
The primary outcome of the study was the change in dental anxiety levels during local anesthesia administration. Secondary outcomes included pain perception, behavioral responses, and physiological changes. The findings of this study aim to provide evidence regarding the effectiveness of VR and MR technologies as distraction tools for anxiety management in pediatric dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Behavioral pain responses were assessed by two independent observers who were blinded to group allocation.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 6 and 12 years.
- •Systemically healthy children.
- •Children requiring dental treatment under local anesthesia.
- •Positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
- •Written informed consent obtained from parents or legal guardians.
排除标准
- •Presence of systemic disease or neurological disorders.
- •Visual or auditory impairment that could interfere with the use of head-mounted displays.
- •History of epilepsy, vertigo, or motion sickness related to audiovisual stimulation.
- •Negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
- •Refusal to use virtual reality or mixed reality devices.
研究组 & 干预措施
Virtual Reality (VR) Group
Children who preferred virtual reality distraction received audiovisual content through a head-mounted display during local anesthesia administration. The virtual reality mode provided a fully immersive environment intended to reduce dental anxiety and pain perception.
干预措施: Audiovisual Distraction Using Head-Mounted Display (Behavioral)
Mixed Reality (MR) Group
Children who preferred mixed reality distraction received audiovisual content through a head-mounted display during local anesthesia administration. The mixed reality mode allowed interaction with virtual content while maintaining partial awareness of the clinical environment to support anxiety and pain control.
干预措施: Audiovisual Distraction Using Head-Mounted Display (Behavioral)
结局指标
主要结局
Change in Dental Anxiety Level During Local Anesthesia
时间窗: Immediately before and during local anesthesia administration
Dental anxiety levels were assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). Anxiety scores were recorded before and during local anesthesia administration to evaluate changes associated with virtual reality and mixed reality distraction methods.
次要结局
- Pain Perception During Local Anesthesia(During local anesthesia administration)
- Behavioral Pain Response Assessed by FLACC Scale(During local anesthesia administration)
- Heart Rate Changes During Local Anesthesia(Immediately before, after and during local anesthesia administration)
研究者
Enes Mustafa AŞAR
Assistant professor
Selcuk University