The Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Dental Anxiety Before Local Anesthesia in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)
研究概览
简要总结
Background: A child's first dental experience plays a crucial role in treatment success and in fostering cooperation during future visits. In pediatric dentistry, various non-pharmacological approaches have been implemented to prepare children for dental procedures. This study aims to evaluate the effects of two such approaches-therapeutic play and virtual reality glasses-designed to familiarize children with dental instruments, on pain perception and dental anxiety.
Methods: A total of 66 healthy children aged 6-9 years attending their first dental visit at the Pediatric Dentistry Clinic of Ataturk University will be included. Participants will be randomly assigned into three groups: one group will receive therapeutic play before local anesthesia; the second group will use virtual reality glasses before local anesthesia; and the control group will receive local anesthesia without any preparatory intervention. Dental anxiety and pain will be assessed using the Modified Children's Dental Anxiety Scale (MCDAS), the Wong-Baker FACES Pain Rating Scale (WBS), and the FLACC scale. Physiological parameters including heart rate and oxygen saturation will be recorded before and after anesthesia.
详细描述
Children often experience dental anxiety during their first dental visit, particularly before local anesthesia. Non-pharmacological approaches such as therapeutic play and virtual reality distraction may help reduce anxiety and pain perception. This randomized controlled trial compared the effectiveness of therapeutic play and virtual reality glasses with routine care in reducing dental anxiety and pain in children aged 6-9 years. Anxiety was assessed using the Modified Children's Dental Anxiety Scale, pain was evaluated using the Wong-Baker FACES Pain Rating Scale and FLACC scale, and physiological parameters were recorded.
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
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 9 years
- •Attending their first dental visit
- •Participation voluntarily approved by both the child and the parent or legal guardian
排除标准
- •Presence of acute dental pain
- •Presence of systemic health problems
- •Allergy to the modeling compound used in the playset
- •Any visual or auditory impairment that could interfere with the use of virtual reality glasses
研究组 & 干预措施
Arm 1: Therapeutic Play Group
Therapeutic play intervention before local anesthesia
干预措施: Intervention 1: Therapeutic Play Group (Device)
Arm 2: Virtual Reality Glasses Group
Use of virtual reality glasses before local anesthesia
干预措施: Intervention 2: Virtual Reality Glasses Group (Behavioral)
Arm 3: Control Group
Routine local anesthesia without preparatory intervention
干预措施: control group (Other)
结局指标
主要结局
Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)
时间窗: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Dental anxiety assessed using the Modified Child Dental Anxiety Scale (MCDAS), a validated questionnaire consisting of 8 items. Total scores range from 8 to 40, with higher scores indicating higher dental anxiety.
Pain score measured by the Wong-Baker FACES Pain Rating Scale
时间窗: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Pain score measured by the FLACC scale
时间窗: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), with scores ranging from 0 to 10, where higher scores indicate more severe pain.
次要结局
- Heart Rate (beats per minute)(Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection)
- Oxygen Saturation (SpO₂)(Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection)
研究者
Mehpare Yener
DDS, Assistant Professor
Ataturk University