- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07245030
Effectiveness of Virtual Reality vs Show-Do Technique on Dental Anxiety in Children With Hearing Impairment
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Not yet recruiting
- October University for Modern Sciences and Arts
-
Contact:
- Tamara Saleh Mohammed Alhasham Master Student, bachelor degree
- Phone Number: 00201091778813
- Email: tamara.saleh1@msa.edu.eg
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Giza Governorate
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Giza, Giza Governorate, Egypt, 12611
- Recruiting
- October University for Modern Sciences and Arts
-
Contact:
- Tamara Saleh Mohammed Alhasham Master Student, bachelor degree
- Phone Number: 00201091778813
- Email: tamara.saleh1@msa.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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:
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 |
children wear virtual reality glasses during dental prophylaxis procedure to reduce dental anxiety and enhance patient's behavior.
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|
Active Comparator: 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.
|
conventional behavioral technique where the dentist shows and then perform the procedure to reduce anxiety and build cooperation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.)
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immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)
|
|
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)
|
immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tamara MSA University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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