The Effect of Virtual Reality Glasses on Pain Perception

NCT07167394 | Enrolling By Invitation

• 1 other identifier: 2023.18/2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Dental Anxiety

Keywords

virtual reality; dental anxiety; dental pain; behavior management

Outcome Measures

Primary Outcomes (5)

• 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: 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: 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.

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

Study Arms (2)

Virtual Reality Game Group

EXPERIMENTAL

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

Tell-Show-Do Group

EXPERIMENTAL

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

Interventions

Interactive Virtual Reality Guidance with Restorative Dental Treatment 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.

Virtual Reality Game Group

Tell-Show-Do Guidance with Restorative Dental Treatment 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.

Tell-Show-Do Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Dentistry, Pediatric Dentistry Dept

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although the intervention is not blinded to participants or care providers due to the visible nature of the VR headset and behavioral techniques, the individuals evaluating outcome measures (such as anxiety and pain scores) are blinded to group assignment. Self-reported scales are collected by an independent researcher not involved in the intervention delivery. Additionally, the data analysis will be conducted using anonymized group labels (Arm 1 / Arm 2), ensuring that the statistician remains blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: The study consist of two arms including Virtual Reality Game Group and Tell-Show-Do Group.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: September 11, 2025
• Study Start: September 8, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)