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The aim of this study is to investigate whether the use of virtual reality (VR) headsets can have a positive effect on dental fear during dental procedures and stress induced by the dental environment. Particular attention is paid to children with mild intellectual disabilities and those living with neurodevelopmental disorders (autism spectrum disorder), for whom these factors may hinder the successful completion of procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with special needs who wear VR headsets during dental treatment. | Experimental |
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| Children with special needs who participate in dental treatment without VR headsets. | Active Comparator |
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| Typically developing children who wear VR headsets during dental treatment | Experimental |
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| Typically developing children who participate in the study without using VR glasses. | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality headset | Device | Useing VR headset during dental treatments |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Dental Anxiety via Venham Picture Scale (VPS) | The VPS is a self-report visual scale consisting of 8 pairs of drawings representing anxious and non-anxious children. The child selects the picture that best reflects their emotional state. Total score ranges from 0 (no anxiety) to 8 (maximum anxiety). Higher scores indicate higher anxiety. | Evaluated at 6 specific time points: immediately before and within 5 minutes after the dental examination (Session 1, Day 1), the oral hygiene treatment (Session 2, Day 22), and the restorative treatment (Session 3, Day 43). |
| Physiological Manifestation of Dental Anxiety via Pulse Rate | Objective, physiological measurement of actual dental anxiety and stress response. Heart rate (measured in beats per minute) is used as an objective indicator for sympathetic nervous system arousal triggered by dental fear. | Continuously monitored (every 4 seconds) during each procedure: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Dental Anxiety via Facial Image Scale (FIS) | The FIS is a self-report scale comprising 5 faces ranging from very happy (score 1) to very unhappy (score 5). The child points to the face they feel most like at the moment. Higher scores indicate greater distress | Evaluated at 6 specific time points: immediately before and within 5 minutes after the dental examination (Session 1, Day 1), the oral hygiene treatment (Session 2, Day 22), and the restorative treatment (Session 3, Day 43). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | 1088 | Hungary |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D004194 | Disease |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002659 | Child Development Disorders, Pervasive |
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| standard dental care | Other | Standard dental treatments without VR headset |
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| Child Cooperation and Behavior via Frankl Behavior Rating Scale (FBRS) | The FBRS is a 4-point clinical rating scale used by the dentist to evaluate child cooperation. Scores range from 1 (definitely negative, refusal of treatment) to 4 (definitely positive, good rapport and enjoyment of the treatment). Higher scores indicate better cooperation. | Evaluated within 5 minutes after the completion of each active procedure and reported for each session: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43). |
| Clinical Evaluation of Behavior via Venham Anxiety and Behavior Scale (VABS) | A 6-point clinical rating scale (ranging from 0 to 5) scored by the investigator to assess the child's state of anxiety and cooperative behavior based on specified objective behavioral criteria during dental care. A score of 0 represents a calm, relaxed state, while a score of 5 indicates extreme anxiety accompanied by the total refusal of dental treatment. Higher scores reflect greater anxiety and uncooperative behavior. | Evaluated within 5 minutes after the completion of each active procedure and reported for each session: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43). |
| Change in Dental Anxiety via Dental Anxiety Scale (DAS) | A 4-item self-report questionnaire assessing general dental anxiety. Each item is scored on a 5-point scale. Total score ranges from 4 (no anxiety) to 20 (severe anxiety). Higher scores indicate higher levels of dental anxiety. | Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43). |
| Change in Dental Fear via Dental Fear Survey (DFS) | A 20-item self-report questionnaire measuring a participant's denral fear. Items are scored on a 5-point scale. Total score ranges from 20 to 100. Higher scores indicate more negative beliefs and lower trust. | Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43). |