The Effect of Immersive Game Experience on Preoperative Anxiety and Compliance in Children Undergoing Supernumerary Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Screen for Child Anxiety Related Emotional Disorders (SCARED)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether immersive game experience (IGE) can improve preoperative anxiety, compliance, and parental satisfaction in children aged 4-12 years undergoing supernumerary tooth extraction under general anesthesia. The main questions are:
Does IGE reduce anxiety measured by SCARED scores, heart rate, salivary cortisol, and LF/HF ratio?
Does IGE improve children's compliance and parental satisfaction?
Participants are randomized 1:1 to standard care or standard care plus IGE, which includes role-playing, parent-child interactive games, environmental adjustments, and rewards. Written informed consent is obtained from legal guardians, and all procedures follow ethical guidelines approved by Jiaxing First Hospital Ethics Committee (2025-LP-044). Outcomes are assessed by blinded staff using validated scales and physiological measures.
详细描述
The goal of this clinical trial is to evaluate whether immersive game experience (IGE) can improve preoperative emotional management, compliance, and parental satisfaction in children undergoing supernumerary tooth extraction. The main questions it aims to answer are:
Does immersive game experience reduce preoperative anxiety as measured by SCARED scores, heart rate, salivary cortisol, and LF/HF ratio?
Does immersive game experience improve children's compliance (Frankl compliance score) and parental satisfaction?
If there is a comparison group: Researchers will compare the control group receiving standard care (including environmental temperature control, preoperative psychological counseling, and parent-guided distraction) with the intervention group receiving standard care plus immersive game experience, to see if the intervention improves anxiety management, compliance, and satisfaction.
Participants will:
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)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with impacted supernumerary teeth by panoramic radiograph and/or cone-beam CT (CBCT)
- •ASA physical status I or II
- •No sensory, auditory, or visual impairments
- •No diagnosed psychiatric or neurodevelopmental disorders
- •Legal guardian able to understand the study and provide written informed consent
- •Child able to understand basic instructions
排除标准
- •Require emergency surgery
- •Significant developmental delay or cognitive impairment
- •History of severe adverse reaction to sedation/anesthesia
- •Active systemic infection or fever (>38°C) at admission
- •Legal guardian with cognitive impairment or unable to complete questionnaires
- •Child refuses participation after explanation
研究组 & 干预措施
Control Group
Participants receive standard preoperative care, including environmental temperature control, preoperative psychological counseling, and parent-guided distraction.
干预措施: Standard Care (Other)
Intervention Group
Participants receive standard care plus immersive game experience.
干预措施: Immersive Game Experience (IGE) (Behavioral)
结局指标
主要结局
Screen for Child Anxiety Related Emotional Disorders (SCARED)
时间窗: Before intervention and preoperative period
Anxiety level of children will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED) questionnaire, which contains 41 items scored on a 3-point Likert scale (0 = Not True or Hardly Ever True, 1 = Somewhat True or Sometimes True, 2 = Very True or Often True). The total score ranges from 0 to 82, with higher scores indicating greater anxiety severity (worse outcome).
Heart Rate
时间窗: Before intervention and preoperative period
Heart rate monitored to assess physiological anxiety response during the preoperative period.
Salivary Cortisol
时间窗: Before intervention and preoperative period
Cortisol concentration measured using high-sensitivity ELISA to evaluate stress response.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
时间窗: Before intervention and preoperative period
Anxiety level of children will be assessed using the Screen for Child Anxiety Related Emotional Disorders (SCARED) questionnaire, which contains 41 items scored on a 3-point Likert scale (0 = Not True or Hardly Ever True, 1 = Somewhat True or Sometimes True, 2 = Very True or Often True). The total score ranges from 0 to 82, with higher scores indicating greater anxiety severity (worse outcome).
Heart Rate
时间窗: Before intervention and preoperative period
Heart rate monitored to assess physiological anxiety response during the preoperative period.
Salivary Cortisol
时间窗: Before intervention and preoperative period
Cortisol concentration measured using high-sensitivity ELISA to evaluate stress response.
次要结局
- Parental Satisfaction(Immediately after procedure)
- Frankl Compliance Rating(During preoperative intervention and procedure)
研究者
YiHong Shao
Resident Physician, Department of Head and Neck Surgery,
Affiliated Hospital of Jiaxing University