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

NCT ID: NCT07245030

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Anxiety of Hearing Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

virtual reality distraction

Intervention Type DEVICE

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:

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.

Group Type ACTIVE_COMPARATOR

show-do technique

Intervention Type BEHAVIORAL

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

Interventions

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virtual reality distraction

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

Intervention Type DEVICE

show-do technique

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Children with moderate to severe Hearing impairment.
2. Children require dental prophylaxis.
3. Apparently, Health Children.

Exclusion Criteria

1. Children with severe cognitive impairment or developmental disorders.
2. Children who are unable or unwilling to cooperate with the study protocol or assessment.
3. Children with complicated systemic diseases.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Tamara Saleh

general practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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October University for Modern Sciences and Arts

Giza, Giza Governorate, Egypt

Site Status RECRUITING

October University for Modern Sciences and Arts

Giza, , Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Facility Contacts

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Tamara Saleh Mohammed Alhasham Master Student, bachelor degree

Role: primary

00201091778813

Tamara Saleh Mohammed Alhasham Master Student, bachelor degree

Role: primary

00201091778813

Other Identifiers

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Tamara MSA University

Identifier Type: -

Identifier Source: org_study_id

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