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NCT Number: NCT07245030

Effectiveness of Virtual Reality vs Show-Do Technique on Dental Anxiety in Children With Hearing Impairment

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October University for Modern Sciences and Arts, Giza, Giza Governorate, Egypt

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About this study

Dental anxiety is a common barrier to effective dental care in pediatric patients, particularly in children with special health care needs such as hearing impairment. Communication limitations can increase anxiety and reduce cooperation, complicating dental treatment delivery. Traditional non-pharmacological techniques such as the Show-Do (SD) method are widely used to reduce anxiety by familiarizing children with dental procedures through demonstration and gradual exposure. However, their effectiveness may be limited in children with hearing impairments, who may not fully understand auditory or verbal explanations.

Virtual reality (VR) eyewear represents an innovative behavioral management tool that immerses the child in an interactive and engaging virtual environment, thereby diverting attention away from the dental procedure and reducing anxiety. Evidence from recent systematic reviews indicates that VR interventions can significantly decrease pain perception and anxiety in pediatric medical and dental settings, yet studies specifically targeting children with hearing impairment remain scarce.

This randomized controlled trial will be conducted at the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Participants will include children with varying levels of hearing impairment requiring dental prophylaxis. Eligible participants will be randomly assigned in a 1:1 ratio to either the control group (Show-Do technique only) or the intervention group (Show-Do technique combined with VR eyewear). Dental anxiety will be measured objectively using pulse oximetry and subjectively using the PJS-Pictorial Scale, while behavior will be assessed using the Frankl Behavior Rating Scale.

The study is designed to generate clinical evidence regarding the efficacy of integrating VR eyewear with conventional behavioral management methods for children with communication challenges. The results are expected to contribute to the development of inclusive, non-pharmacological strategies to manage dental anxiety and improve cooperation among pediatric patients with hearing impairments, ultimately enhancing patient-centered care in pediatric dentistry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Virtual reality distraction

Device

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

show-do technique

Behavioral

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

Primary outcomes

  1. anxiety level (objective)

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

    tool: pulse oximeter unit: beats per minute

Secondary outcomes

  1. anxiety level (subjective)

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

    tool: Pictorial Judgement Scale for Anxiety Assessment (PJS-pictorial scale) unit: score 1-5, (1: means very happy, 5: means very anxious.)

  2. behavior assessment

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

    tool: Frankel rating scale unit: score 1-4 (1: means definitely negative and 4: means definitely positive)

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

A Comparative Evaluation of the Effectiveness of Virtual Reality Eyewear vs Show-Do Technique on Dental Anxiety and Behavior in a Group of Children With Different Levels of Hearing Impairment During Dental Prophylaxis Procedure: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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