The Effect of Immersive Game Experience on Preoperative Anxiety and Compliance in Children Undergoing Supernumerary Tooth Extraction

NCT07149727 | Completed DMC

• 1 other identifier: 2025-LP-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Supernumerary Teeth

Keywords

Teeth; Preoperative Anxiety; Pediatric Dentistry; Immersive Game; Behavioral Intervention

Outcome Measures

Primary Outcomes (3)

• Screen for Child Anxiety Related Emotional Disorders (SCARED)

  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).

  Before intervention and preoperative period

• Heart Rate

  Heart rate monitored to assess physiological anxiety response during the preoperative period.

  Before intervention and preoperative period

• Salivary Cortisol

  Cortisol concentration measured using high-sensitivity ELISA to evaluate stress response.

  Before intervention and preoperative period

Secondary Outcomes (2)

• Frankl Compliance Rating

  During preoperative intervention and procedure

• Parental Satisfaction

  Immediately after procedure

Study Arms (2)

Control Group

OTHER

Participants receive standard preoperative care, including environmental temperature control, preoperative psychological counseling, and parent-guided distraction.

Other: Standard Care

Intervention Group

ACTIVE COMPARATOR

Participants receive standard care plus immersive game experience.

Behavioral: Immersive Game Experience (IGE)

Interventions

Standard Care OTHER

Environmental temperature control, preoperative psychological counseling, and parent-guided distraction.

Control Group

Immersive Game Experience (IGE) BEHAVIORAL

Standard care plus immersive game experience, including role-playing scenarios (e.g., using dolls to simulate IV puncture), parent-child interactive games, environmental adjustments (children's music, colorful objects), and post-intervention rewards (cartoon stickers).

Intervention Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• YiHong Shao: lead

Study Sites (1)

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314001, China

Location

MeSH Terms

Conditions

Tooth, Supernumerary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician, Department of Head and Neck Surgery,

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)