NCT07245030

Brief Summary

This randomized controlled clinical trial aims to compare the effectiveness of virtual reality (VR) eyewear used as a distraction method in combination with the Show-Do (SD) technique versus the traditional Show-Do technique alone in managing dental anxiety and improving behavioral responses among Egyptian children with different levels of hearing impairment during a dental prophylaxis procedure. The study will evaluate dental anxiety using pulse rate and the PJS-Pictorial Scale, while behavior will be assessed using the Frankl Behavior Rating Scale. The trial seeks to provide evidence-based guidance on the implementation of VR technology as an adjunctive non-pharmacological tool for children with communication barriers in pediatric dentistry.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 24, 2025

Status Verified

October 1, 2025

Enrollment Period

11 days

First QC Date

November 16, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

dental prophylaxis procedurescalingpolishingoral hygiene instructionsvirtual realityAnxietybehavioralhearing impairment

Outcome Measures

Primary Outcomes (1)

  • anxiety level (objective)

    tool: pulse oximeter unit: beats per minute

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

Secondary Outcomes (2)

  • anxiety level (subjective)

    immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)

  • behavior assessment

    immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)

Study Arms (2)

Children with different levels of hearing impairment, using Show-Do Technique in combined with VR ey

EXPERIMENTAL

A- Show-Do Technique: Description: This technique will be integrated with the VR eyewear intervention to enhance understanding and comfort. The show-do technique involves: * Show: The child will be shown the dental tools and explain their purpose, possibly using visual aids or models. * Do: The procedure will be Performed as explained with continuous reassurance and support. B- Virtual Reality Component: Participants in this group will experience a virtual reality (VR) eyewear in an environment designed to distract them during dental prophylaxis procedure. The VR content will be age-appropriate and engaging, and featuring interactive (e.g., Fun animations, and Cartoons). Implementation: Before the dental treatment and after the implementation with show-do, children will be fitted with VR eyewear, where the aim is to immerse the child in the VR experience to reduce their focus on the dental treatment. Duration: • The VR eyewear experience will last for the duration of t

Device: virtual reality distraction

Children with different levels of hearing impairment, using Show-Do Technique:

ACTIVE COMPARATOR

Participants in this group will receive the standard show-do technique without the VR eyewear distraction. The same steps (Show, Do) will be employed to prepare the child for the dental procedure, but without the use of VR technology.

Behavioral: show-do technique

Interventions

children wear virtual reality glasses during dental prophylaxis procedure to reduce dental anxiety and enhance patient's behavior.

Children with different levels of hearing impairment, using Show-Do Technique in combined with VR ey

conventional behavioral technique where the dentist shows and then perform the procedure to reduce anxiety and build cooperation.

Children with different levels of hearing impairment, using Show-Do Technique:

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with moderate to severe Hearing impairment.
  • Children require dental prophylaxis.
  • Apparently, Health Children.

You may not qualify if:

  • Children with severe cognitive impairment or developmental disorders.
  • Children who are unable or unwilling to cooperate with the study protocol or assessment.
  • Children with complicated systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

October University for Modern Sciences and Arts

Giza, Giza Governorate, 12611, Egypt

RECRUITING

October University for Modern Sciences and Arts

Giza, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Anxiety DisordersBehaviorHearing Loss

Condition Hierarchy (Ancestors)

Mental DisordersHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general practitioner

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 24, 2025

Study Start

November 20, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Locations