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Virtual RealityNCT07167394

The Effect of Virtual Reality Glasses on Pain Perception

A study testing Interactive Virtual Reality Guidance with Restorative Dental Treatment and Tell-Show-Do Guidance with Restorative Dental Treatment in people with Virtual Reality and Dental Anxiety, run by Ankara University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear… Read more about this study

Who is it for?
Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Virtual Reality, Dental Anxiety
What is being tested?
Interactive Virtual Reality Guidance with Restorative Dental Treatment and Tell-Show-Do Guidance with Restorative Dental Treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Sep 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 6 to 10 years
  • No previous dental treatment history
  • No systemic or chronic medical conditions
  • No mental retardation
  • No psychiatric pathology based on CBCL, K-SADS-PL-T, and SCARED (SCARED score <25)
  • Presence of dentin caries on mandibular molars (mesio-occlusal or disto-occlusal)
  • Signed informed consent by parent/Guardian

Who cannot join

  • Prior dental treatment experience
  • SCARED score ≥25
  • Diagnosed psychological or developmental disorders
  • Acute dental pain or irreversible pulp involvement
  • Decline to sign informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ankara University, Faculty of Dentistry, Pediatric Dentistry Dept

    Ankara, Yenimahalle, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Presenting Restorative Dental Treatments in a Game Format Using Virtual Reality Glasses on Anxiety and Pain Perception in Children

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence.

On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future.

Read more

This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures.

A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique.

In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety.

In the other group, behavior management will be provided using the tell-show-do method. This includes explaining procedures using child-friendly language (tell), demonstrating non-threatening aspects of the instruments and environment (show), and performing the procedures accordingly (do).

After informed consent is obtained, the treating dentist will select teeth based on clinical and radiographic criteria. Dento-alveolar images will be reviewed using VR glasses and explained to the parent, who will also wear VR glasses for an immersive consultation experience. A caries detection tool powered by artificial intelligence will support diagnosis.

Treatments will be performed on the lower primary molars with mesio-occlusal or disto-occlusal caries not involving the pulp.

Pain perception and anxiety will be evaluated using psychometric scales (SCARED, CFSS-DS, Wong-Baker, STAIC) and physiological measurements (pulse oximeter, heart rate) at standardized intervals: before, during, and after treatment.

It is hypothesized that the VR-based game will result in lower anxiety and pain perception, greater cooperation, and more positive dental experiences compared to the tell-show-do method.

Read the detailed description

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence.

On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future.

This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures.

A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique.

In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety.

In the other group, behavior management will be provided using the tell-show-do method. This includes explaining procedures using child-friendly language (tell), demonstrating non-threatening aspects of the instruments and environment (show), and performing the procedures accordingly (do).

After informed consent is obtained, the treating dentist will select teeth based on clinical and radiographic criteria. Dento-alveolar images will be reviewed using VR glasses and explained to the parent, who will also wear VR glasses for an immersive consultation experience. A caries detection tool powered by artificial intelligence will support diagnosis.

Treatments will be performed on the lower primary molars with mesio-occlusal or disto-occlusal caries not involving the pulp.

To ensure the exclusion of children with underlying psychopathologies, participants will first be screened using the Child Behavior Checklist (CBCL) and the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). Only those without psychiatric indications will be included in the study.

Pain perception and anxiety will be evaluated using psychometric scales (SCARED, CFSS-DS, Wong-Baker, STAIC) and physiological measurements (pulse oximeter, heart rate) at four standardized intervals: before treatment, during anesthesia administration, during the procedure, and after treatment.

It is hypothesized that the VR-based game will result in lower anxiety and pain perception, greater cooperation, and more positive dental experiences compared to the tell-show-do method.

Being tested
Interactive Virtual Reality Guidance with Restorative Dental Treatment, Tell-Show-Do Guidance with Restorative Dental Treatment
Keywords
virtual reality, dental anxiety, dental pain, behavior management
Medical subject headings
Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive Virtual Reality Guidance with Restorative Dental TreatmentProcedure or surgery

    Participants in this group will undergo a standardized restorative dental procedure on mandibular primary molars involving local anesthesia, caries excavation, and compomer restoration. Prior to the treatment, children will wear a virtual reality (VR) headset through which they will experience an interactive, animated educational game.

    The VR content simulates the treatment steps-including sitting in the chair, receiving local anesthesia, caries removal, filling, and polishing-using engaging characters and storytelling. The aim is to reduce anxiety and perceived pain through immersive visual and cognitive distraction while standard dental procedures are being performed.

  • Tell-Show-Do Guidance with Restorative Dental TreatmentProcedure or surgery

    Participants in this group will also receive a standardized restorative dental procedure identical to the VR group, including local anesthesia, caries removal, and compomer filling of mandibular primary molars. Behavioral preparation will be conducted using the conventional Tell-Show-Do technique. The clinician will verbally explain each step, demonstrate the procedure using visual and tactile tools in a child-friendly manner, and then proceed with the actual intervention. This method aims to reduce dental fear and increase compliance by familiarizing the child with the clinical environment before the surgical procedure.

Study groups in NCT07167394
Study groupRoleWhat they receive
Virtual Reality Game GroupExperimentalChildren in this group will receive restorative dental treatment following a virtual reality-based animated educational game presented via VR headset. The game introduces each treatment step in a child-friendly narrative to reduce anxiety and perceived pain.
Receives: Procedure: Interactive Virtual Reality Guidance with Restorative Dental Treatment
Tell-Show-Do GroupExperimentalChildren in this group will receive the same restorative dental treatment after conventional behavioral preparation using the Tell-Show-Do technique, where each procedure is verbally explained and visually demonstrated prior to treatment.
Receives: Procedure: Tell-Show-Do Guidance with Restorative Dental Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State-Trait Anxiety Inventory for Children - Dental Version

    Description: A validated self-report questionnaire used to evaluate children's state and trait anxiety levels in dental settings.

    Score Range: 20 to 60 for each subscale (State and Trait). Interpretation: Higher scores indicate greater anxiety levels.

    Measured: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.

  2. SCARED (Screen for Child Anxiety Related Emotional Disorders)

    Description: A validated self-report tool assessing symptoms of anxiety disorders in children.

    Score Range: 0 to 82. Interpretation: Higher scores reflect greater anxiety. Scores ≥25 suggest clinically significant anxiety.

    Measured: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.

  3. Pulse Rate Monitoring via Pulse Oximeter

    Description: Objective physiological measurement of heart rate used as an indicator of anxiety. Pulse rate will be recorded at multiple standardized time points.

    Score Range: Beats per minute (bpm); continuous numerical data. Interpretation: Higher pulse rates are associated with increased physiological anxiety.

    Measured: T1: Baseline - before the patient is seated in the dental chair. T2: During local anesthesia administration. T3: During the restorative treatment. T4: Within 5 minutes after completion of the treatment.

  4. Wong-Baker Faces Pain Rating Scale

    Description: A self-assessment scale where children rate their pain using illustrated facial expressions.

    Score Range: 0 to 10. Interpretation: Higher scores represent greater perceived pain.

    Measured: Time Frame: After local anesthesia administration and within 20 minutes after the end of the restorative treatment for each arm.

  5. Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)

    Description: Standardized questionnaire evaluating children's dental-specific fears.

    Score Range: 15 to 75. Interpretation: Higher scores indicate higher dental fear. A score >38 is typically considered high.

    Measured: Time Frame: Within 20 minutes after the end of the restorative treatment for each arm.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start8 Sep 2025
  3. Primary completion15 Feb 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study consist of two arms including Virtual Reality Game Group and Tell-Show-Do Group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07167394
Sponsor's protocol ID
2023.18/2
Status last verified
Sep 2025
First submitted
8 Jul 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in the study publication (after deidentification), including raw data for primary and secondary outcome measures, may be shared upon reasonable request. Supporting documentation such as the study protocol and statistical analysis plan may also be made available upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Virtual Reality Guidance with Restorative Dental Treatment and Tell-Show-Do Guidance with Restorative Dental Treatment in people with Virtual Reality and Dental Anxiety, run by Ankara University at 1 site in Turkey (Türkiye).

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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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?

State-Trait Anxiety Inventory for Children - Dental Version (time frame: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.). The study lists 5 primary outcomes in all. 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 11 Sep 2025.

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