Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients

NCT06964451 | Completed

• 2 other identifiers: 01-14788/2022Ethics Committee
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.

Conditions

Virtual Reality; Distraction; Gamification; Tooth Extraction

Keywords

virtual reality; distraction; gamification; tooth extraction; MIH

Outcome Measures

Primary Outcomes (2)

• Face Scale

  We used the Wong-Baker Face Scale to assess pain, which allows patients to visually describe their level of pain. This scale consists of six faces with different expressions, ranging from a face showing no pain to a face representing the worst possible pain. This method of assessment is particularly useful for children. Pain was recorded during the administration of anaesthesia and during the tooth extraction procedure

  1 day

• Heart rate

  Additionally, heart rate was monitored to assess the patient's physiological response to stress and pain during the procedure. Heart rate was recorded during anaesthesia administration and during the procedure using a smartwatch that allows continuous heart rate tracking (Samsung Galaxy Watch). This type of measurement provides additional information on how the patient responds to pain and stress, enabling the dentist to adjust their approach according to the patient's physiological response.

  1 day

Secondary Outcomes (1)

• Satisfaction questionnaire

  1 day

Study Arms (2)

NON VR

ACTIVE COMPARATOR

In the extraction of one tooth, the procedure was performed according to the standard protocol (Non VR Phase).

Procedure: Extraction tooth

VR

ACTIVE COMPARATOR

For the tooth on the opposite side, the entire extraction procedure (including the application of local anesthesia) was conducted using a gamification model with VR goggles (VR Gamification Phase)

Procedure: Extraction tooth

Interventions

Extraction tooth PROCEDURE

Extraction of MIH Grade 4 molar

NON VR; VR

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Indication for the extraction of both lower first molars due MIH grade 4.

Sponsors & Collaborators

• Rasa Mladenovic: lead

Study Sites (1)

Faculty od Medical Sciences University of Kragujevac

Kragujevac, 34000, Serbia

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor, Pediatric dentist

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 9, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)