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Completed

NCT Number: NCT07398105

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

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.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, 42150, Turkey (Türkiye)

About this study

Dental anxiety in children is associated with increased pain perception, behavioral problems, and reduced treatment compliance. Managing anxiety during dental procedures is therefore a critical component of pediatric dental care. Conventional behavior guidance techniques may not always be sufficient, particularly during invasive procedures such as local anesthesia administration.

This randomized, parallel-group clinical trial was conducted to compare the effects of virtual reality (VR) and mixed reality (MR) head-mounted displays on dental anxiety and pain perception in pediatric patients. The study included 142 systemically healthy children aged between 6 and 12 years who required dental treatment under local anesthesia. Only children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale were included.

Participants were randomly allocated into two groups: a VR group and an MR group. During local anesthesia administration, children in the VR group were exposed to a fully immersive virtual environment, while children in the MR group interacted with virtual content while maintaining partial awareness of the clinical environment.

Dental anxiety was evaluated using the Children's Fear Survey Schedule-Dental Subscale, and pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. Behavioral pain responses during local anesthesia were scored using the FLACC scale by two independent observers. Heart rate measurements were recorded as a physiological indicator of anxiety. Interobserver reliability for behavioral assessments was also evaluated.

The primary outcome of the study was the change in dental anxiety levels during local anesthesia administration. Secondary outcomes included pain perception, behavioral responses, and physiological changes. The findings of this study aim to provide evidence regarding the effectiveness of VR and MR technologies as distraction tools for anxiety management in pediatric dentistry.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Dental Anxiety Level During Local Anesthesia

    Time frame: Immediately before and during local anesthesia administration

    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.

Secondary outcomes

  1. Pain Perception During Local Anesthesia

    Time frame: During local anesthesia administration

    Pain perception was evaluated using the Wong-Baker FACES Pain Rating Scale during local anesthesia administration.

  2. Behavioral Pain Response Assessed by FLACC Scale

    Time frame: During local anesthesia administration

    Behavioral pain responses during local anesthesia administration were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale by two independent observers.

  3. Heart Rate Changes During Local Anesthesia

    Time frame: Immediately before, after and during local anesthesia administration

    Heart rate was measured as a physiological indicator of anxiety before and during local anesthesia administration.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

A Clinical Study Comparing Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety and Pain Control During Local Anesthesia in Children

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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