The Effect of Immersive Game Experience on Preoperative Anxiety and Compliance in Children Underg… (NCT07149727) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Immersive Game Experience on Preoperative Anxiety and Compliance in Children Undergoing Supernumerary Tooth Extraction
China40 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Timeframe: Before intervention and preoperative period
2
Heart Rate
Timeframe: Before intervention and preoperative period
3
Salivary Cortisol
Timeframe: Before intervention and preoperative period