Health TrialsbyHealthPanel

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

ConditionMolar Incisor Hypomineralization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

MIH-affected molars require apexogenesis, apexification, regeneration or RCT.

Non-restorable tooth.

Previous restorative treatment.

Periodontally affected.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Virtual Reality Distraction

    Device

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

  • Tell-Show-Do Technique

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm A: Virtual Reality then Tell-Show-DoExperimental treatment 2 interventions
Group B: Arm B: Tell-Show-Do then Virtual RealityActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pain perception

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

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

Secondary outcomes

1

Anxiety level

Tool: Modified Child Dental Anxiety Scale (MCDAS-f) Unit: Score 8-40

Time frame
Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)
2

Heart Rate

Tool: Pulse Oximeter Unit: Beats per minute

Time frame
Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
3

Oxygen Saturation

Tool: Pulse Oximeter Unit: %

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: