Immersive Virtual Reality for Pain and Dental Anxiety During Pediatric Restorative Treatment

NCT07781254 | Completed

• 1 other identifier: KAEK-028-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether immersive virtual reality (VR) can help reduce pain and dental fear and improve behavioral cooperation in children undergoing restorative dental treatment. Children aged 8-12 years who required treatment of primary molars were randomly assigned to either a VR group or a control group. Children in the VR group watched an age-appropriate animated video through a VR headset during local anesthesia and dental treatment, while children in the control group received routine dental treatment without VR. Pain, dental anxiety, dental fear, behavioral cooperation, emotional responses, physiological measurements, treatment duration, and parent and clinician satisfaction were assessed and compared between the two groups.

Conditions

Dental Anxiety in Children; Dental Pain; Virtual Reality; Distraction; Dental Caries

Keywords

Virtual Reality; Pediatric dentistry; Dental fear; Pain perception; Behavior guidance; child

Outcome Measures

Primary Outcomes (1)

• Pain Perception

  Pain perception was assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS), with higher scores indicating greater pain intensity.

  During treatment (T1) and immediately after completion of the restorative procedure (T2)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants received immersive virtual reality-based audiovisual distraction during standardized restorative dental treatment. The VR headset was fitted approximately 1 minute before local anesthesia and remained in place throughout the restorative procedure. Participants watched a standardized age-appropriate animated video (Pırıl) for approximately 10-15 minutes.

Behavioral: Immersive Virtual Reality

Control Group

NO INTERVENTION

Participants received routine restorative dental treatment without a distraction intervention. Local anesthesia and restorative procedures were performed according to the same standardized clinical protocol used for the virtual reality group.

Interventions

Immersive Virtual Reality BEHAVIORAL

Immersive virtual reality-based audiovisual distraction using a standardized, age-appropriate animated video during restorative dental treatment.

Virtual Reality Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 8-12 years. Children requiring dental treatment under local anesthesia. Children who are able to understand and follow the study instructions. Children whose parents/legal guardians provide written informed consent. Children who provide age-appropriate assent to participate.

You may not qualify if:

• Children with systemic, neurological, psychiatric, cognitive, or developmental conditions that may affect anxiety or pain assessment.
• Children with visual or auditory impairments that prevent appropriate use of the VR system or communication with the investigator.
• Children with a history of seizures or other conditions for which VR use is contraindicated.
• Children who refuse to participate or whose parents/legal guardians withdraw consent.
• Children who are unable to complete the dental treatment or study assessments.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Faculty of Dentistry

Gaziantep, 27310, Turkey (Türkiye)

Location

Related Publications (4)

• Wu W, Le May S, Hung N, Fortin O, Genest C, Francoeur M, Guingo E, St-Arneault K, Sylfra A, Vu AK, Carmel J, Lessard L, Cara-Slavich S, De Koven K, Paquette J, Hoffman H, Asselin ME. Effects of a Virtual Reality Game on Children's Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 10;12:e49956. doi: 10.2196/49956.

  PMID: 37948113 BACKGROUND

• Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1.

  PMID: 39465519 BACKGROUND

• Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7.

  PMID: 38087294 BACKGROUND

• Yan X, Yan Y, Cao M, Xie W, O'Connor S, Lee JJ, Ho MH. Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. J Dent. 2023 May;132:104455. doi: 10.1016/j.jdent.2023.104455. Epub 2023 Feb 24.

  PMID: 36842625 BACKGROUND

MeSH Terms

Conditions

Toothache; Dental Caries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to either the immersive virtual reality intervention group or the control group. Each participant received treatment according to the assigned group throughout the study.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: May 20, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)