Comparison of Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety Control During Local Anesthesia in Children

NCT07398105 | Completed

• 1 other identifier: SBAE Thesis Project
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Dental anxiety is a common problem in children and may negatively affect cooperation, pain perception, and treatment success during dental procedures. Distraction techniques are widely used to reduce anxiety during dental treatment. In recent years, virtual reality (VR) and mixed reality (MR) technologies have been introduced as innovative audiovisual distraction methods in pediatric dentistry. The aim of this randomized clinical study is to compare the effects of virtual reality and mixed reality head-mounted displays on dental anxiety and pain perception in children during local anesthesia administration. A total of 142 systemically healthy children aged 6 to 12 years who required dental treatment under local anesthesia were included. Participants were randomly assigned to either a VR group or an MR group. Dental anxiety and pain levels were assessed using validated scales before and during local anesthesia administration. Behavioral responses and physiological parameters were also recorded. The results of this study will help determine whether VR or MR provides superior anxiety control during pediatric dental procedures.

Conditions

Dental Anxiety

Keywords

Pediatric Dentistry; Virtual Reality; Mixed Reality; Dental Anxiety; Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in Dental Anxiety Level During Local Anesthesia

  Dental anxiety levels were assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). Anxiety scores were recorded before and during local anesthesia administration to evaluate changes associated with virtual reality and mixed reality distraction methods.

  Immediately before and during local anesthesia administration

Secondary Outcomes (3)

• Pain Perception During Local Anesthesia

  During local anesthesia administration

• Behavioral Pain Response Assessed by FLACC Scale

  During local anesthesia administration

• Heart Rate Changes During Local Anesthesia

  Immediately before, after and during local anesthesia administration

Study Arms (2)

Virtual Reality (VR) Group

OTHER

Children who preferred virtual reality distraction received audiovisual content through a head-mounted display during local anesthesia administration. The virtual reality mode provided a fully immersive environment intended to reduce dental anxiety and pain perception.

Behavioral: Audiovisual Distraction Using Head-Mounted Display

Mixed Reality (MR) Group

OTHER

Children who preferred mixed reality distraction received audiovisual content through a head-mounted display during local anesthesia administration. The mixed reality mode allowed interaction with virtual content while maintaining partial awareness of the clinical environment to support anxiety and pain control.

Behavioral: Audiovisual Distraction Using Head-Mounted Display

Interventions

Audiovisual Distraction Using Head-Mounted Display BEHAVIORAL

Participants received audiovisual distraction through a head-mounted display during local anesthesia administration. The intervention was delivered in two modes based on participant preference: a virtual reality (VR) mode providing a fully immersive audiovisual environment, and a mixed reality (MR) mode allowing interaction with virtual content while maintaining partial awareness of the clinical environment.

Mixed Reality (MR) Group; Virtual Reality (VR) Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6 and 12 years.
• Systemically healthy children.
• Children requiring dental treatment under local anesthesia.
• Positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
• Written informed consent obtained from parents or legal guardians.

You may not qualify if:

• Presence of systemic disease or neurological disorders.
• Visual or auditory impairment that could interfere with the use of head-mounted displays.
• History of epilepsy, vertigo, or motion sickness related to audiovisual stimulation.
• Negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
• Refusal to use virtual reality or mixed reality devices.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Konya, 42150, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Behavioral pain responses were assessed by two independent observers who were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 4, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)