An interventional study of Interactive Virtual Reality Guidance with Restorative Dental Treatment and Tell-Show-Do Guidance with Restorative Dental Treatment in Virtual Reality and Dental Anxiety, sponsored by Ankara University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
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.
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.
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.
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This study's planned enrollment of 88 is close to the median of 84 across 123 interventional studies indexed under Toothache.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children 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.
Procedure: Interactive Virtual Reality Guidance with Restorative Dental Treatment
Children 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.
Procedure: Tell-Show-Do Guidance with Restorative Dental Treatment
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.
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.
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.
Time frame: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.
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.
Time frame: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.
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.
Time frame: 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.
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.
Time frame: Time Frame: After local anesthesia administration and within 20 minutes after the end of the restorative treatment for each arm.
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.
Time frame: Time Frame: Within 20 minutes after the end of the restorative treatment for each arm.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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