Pain Perception and Anxiety With Virtual Reality vs Tell-Show-Do in Children With MIH

NCT07052019 | Not Yet Recruiting DMC

• 1 other identifier: U Cairo Hagar
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot crossover randomized clinical trial aims to compare the effect of distraction using Virtual Reality (VR) versus the Tell-Show-Do (TSD) technique on pain perception and anxiety in children aged 6-12 with Molar Incisor Hypomineralization (MIH) undergoing restorative dental treatment.

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor hypomineralization; MIH; virtual reality; behavioral; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• Pain perception

  Tool: Wong Baker Faces Pain Rating Scale Unit: Score 0-10

  Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)

Secondary Outcomes (3)

• Anxiety level

  Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)

• Heart Rate

  Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)

• Oxygen Saturation

  Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)

Study Arms (2)

Arm A: Virtual Reality then Tell-Show-Do

EXPERIMENTAL

Children receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period).

Device: Virtual Reality Distraction; Behavioral: Tell-Show-Do Technique

Arm B: Tell-Show-Do then Virtual Reality

ACTIVE COMPARATOR

Children receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period).

Device: Virtual Reality Distraction; Behavioral: Tell-Show-Do Technique

Interventions

Virtual Reality Distraction DEVICE

Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.

Arm A: Virtual Reality then Tell-Show-Do; Arm B: Tell-Show-Do then Virtual Reality

Tell-Show-Do Technique BEHAVIORAL

Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.

Arm A: Virtual Reality then Tell-Show-Do; Arm B: Tell-Show-Do then Virtual Reality

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6-12 years.
• Patients with two First Permanent molars diagnosed with MIH indicated for class I cavities.
• A cooperative and compliant patient/ parent.
• Patients not allergic to medicaments necessary to complete the procedure.
• Patients with no history of chronic systemic diseases.

You may not qualify if:

• MIH-affected molars require apexogenesis, apexification, regeneration or RCT.
• Non-restorable tooth.
• Previous restorative treatment.
• Periodontally affected.
• Children having systemic disease, an emotional behavioural or learning disorder.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of dentistry, Cairo university

Giza, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization; Behavior; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant at Pediatric Dentistry Department

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 4, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)