The Effect of Virtual Reality Glasses on Pain Perception

NCT ID: NCT07167394

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2026-03-01

Brief 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.

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.

Conditions

Virtual Reality; Dental Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Game Group

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.

Group Type: EXPERIMENTAL

Interactive Virtual Reality Guidance with Restorative Dental Treatment

Intervention Type: PROCEDURE

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 Group

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.

Group Type: EXPERIMENTAL

Tell-Show-Do Guidance with Restorative Dental Treatment

Intervention Type: PROCEDURE

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.

Interventions

Interactive Virtual Reality 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.

Intervention Type: PROCEDURE

Tell-Show-Do Guidance with Restorative Dental Treatment

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Levent Özer

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University, Faculty of Dentistry, Pediatric Dentistry Dept

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023.18/2

Identifier Type: -

Identifier Source: org_study_id