Dental Anxiety of Hearing ImpairmentNCT07245030
Effectiveness of Virtual Reality vs Show-Do Technique on Dental Anxiety in Children With Hearing Impairment
A study testing virtual reality distraction and show-do technique in people with Dental Anxiety of Hearing Impairment, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Anxiety of Hearing Impairment
- What is being tested?
- virtual reality distraction and show-do technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2025to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with moderate to severe or profound hearing loss.
- Children require dental prophylaxis.
- Apparently, Health Children.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
October University for Modern Sciences and Arts
Giza, Giza Governorate, 12451
About this study
Official 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
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.
Read the 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.
- Conditions
- Dental Anxiety of Hearing Impairment
- Being tested
- virtual reality distraction, show-do technique
- Keywords
- dental prophylaxis procedure, scaling, polishing, oral hygiene instructions, virtual reality, Anxiety, behavioral, hearing impairment
- Medical subject headings
- Anxiety Disorders, Behavior, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality distractionDevice
children wear virtual reality glasses during dental prophylaxis procedure to reduce dental anxiety and enhance patient's behavior.
show-do techniqueBehavioural
conventional behavioral technique where the dentist shows and then perform the procedure to reduce anxiety and build cooperation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: show-do technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level (objective)
tool: pulse oximeter unit: beats per minute
Measured: baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
Secondary outcomes (2)
anxiety level (subjective)
tool: Pictorial Judgement Scale for Anxiety Assessment (PJS-pictorial scale) unit: score 1-5, (1: means very happy, 5: means very anxious.)
Measured: immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)
behavior assessment
tool: Frankel rating scale unit: score 1-4 (1: means definitely negative and 4: means definitely positive)
Measured: immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Dec 2025
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety of Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Saleh, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245030
- Sponsor's protocol ID
- Tamara MSA University
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07245030
- Acronym / sponsor ID
- Tamara MSA University
- Conditions
- Dental Anxiety of Hearing Impairment
- Keywords
- dental prophylaxis procedure, scaling, polishing, oral hygiene instructions, virtual reality, Anxiety, behavioral, hearing impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with different levels of hearing impairment, using Show-Do Technique in combined with VR ey | Experimental | Device: virtual reality distractionA- 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 |
| Children with different levels of hearing impairment, using Show-Do Technique: | Active comparator | Behavioral: show-do techniqueParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with moderate to severe or profound hearing loss.
- Children require dental prophylaxis.
- Apparently, Health Children.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality distractionchildren wear virtual reality glasses during dental prophylaxis procedure to reduce dental anxiety and enhance patient's behavior. | Device | Children with different levels of hearing impairment, using Show-Do Technique in combined with VR ey |
| show-do techniqueconventional behavioral technique where the dentist shows and then perform the procedure to reduce anxiety and build cooperation. | Behavioural | Children with different levels of hearing impairment, using Show-Do Technique: |
Primary outcome
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
2 secondary outcomes
anxiety level (subjective)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality distraction and show-do technique in people with Dental Anxiety of Hearing Impairment, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (objective) (time frame: baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.