The Effect of Immersive Game Experience on Preoperative Anxiety and Compliance in Children Undergoing Supernumerary Tooth Extraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Screen for Child Anxiety Related Emotional Disorders (SCARED)
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control Group
Participants receive standard preoperative care, including environmental temperature control, preoperative psychological counseling, and parent-guided distraction.
Intervention: Standard Care (Other)
Intervention Group
Participants receive standard care plus immersive game experience.
Intervention: Immersive Game Experience (IGE) (Behavioral)
Outcomes
Primary Outcomes
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame: 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
Time Frame: Before intervention and preoperative period
Heart rate monitored to assess physiological anxiety response during the preoperative period.
Salivary Cortisol
Time Frame: Before intervention and preoperative period
Cortisol concentration measured using high-sensitivity ELISA to evaluate stress response.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame: 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
Time Frame: Before intervention and preoperative period
Heart rate monitored to assess physiological anxiety response during the preoperative period.
Salivary Cortisol
Time Frame: Before intervention and preoperative period
Cortisol concentration measured using high-sensitivity ELISA to evaluate stress response.
Secondary Outcomes
- Parental Satisfaction(Immediately after procedure)
- Frankl Compliance Rating(During preoperative intervention and procedure)
Investigators
YiHong Shao
Resident Physician, Department of Head and Neck Surgery,
Affiliated Hospital of Jiaxing University