The Effect of Presenting Restorative Dental Treatments in a Game Format Using Virtual Reality Glasses on Anxiety and Pain Perception in Children
Trial ID: NCT07167394
Status: ENROLLING_BY_INVITATION
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09-08
Completion date: 2026-03-01
Sponsor: Ankara University
Conditions: Virtual Reality; Dental Anxiety
Interventions: Interactive Virtual Reality Guidance with Restorative Dental Treatment; Tell-Show-Do Guidance with Restorative Dental Treatment
Locations: Ankara University, Faculty of Dentistry, Pediatric Dentistry Dept
Countries: Turkey (Türkiye)
Enrollment: 88
Age range: 6 Years - 10 Years
Sex: ALL

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 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.

Eligibility criteria:
Inclusion Criteria:

* 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

Exclusion Criteria:

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

Outcomes:
State-Trait Anxiety Inventory for Children - Dental Version; SCARED (Screen for Child Anxiety Related Emotional Disorders); Pulse Rate Monitoring via Pulse Oximeter; Wong-Baker Faces Pain Rating Scale; Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)