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

NCT07149727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-11

No results posted yet for this study

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

Interventions

OTHER

Standard Care

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

BEHAVIORAL

Immersive Game Experience (IGE)

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).

Sponsors & Collaborators

  • YiHong Shao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149727 on ClinicalTrials.gov