Dental AnxietyNCT07398105
Comparison of Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety Control During Local Anesthesia in Children
A study testing Audiovisual Distraction Using Head-Mounted Display in people with Dental Anxiety, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Audiovisual Distraction Using Head-Mounted Display
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Comparing Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety and Pain 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.
Read the detailed description
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.
- Conditions
- Dental Anxiety
- Being tested
- Audiovisual Distraction Using Head-Mounted Display
- Keywords
- Pediatric Dentistry, Virtual Reality, Mixed Reality, Dental Anxiety, Local Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual Distraction Using Head-Mounted DisplayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Audiovisual Distraction Using Head-Mounted Display |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and during local anesthesia administration
Secondary outcomes (3)
Pain Perception During Local Anesthesia
Pain perception was evaluated using the Wong-Baker FACES Pain Rating Scale during local anesthesia administration.
Measured: During local anesthesia administration
Behavioral Pain Response Assessed by FLACC Scale
Behavioral pain responses during local anesthesia administration were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale by two independent observers.
Measured: During local anesthesia administration
Heart Rate Changes During Local Anesthesia
Heart rate was measured as a physiological indicator of anxiety before and during local anesthesia administration.
Measured: Immediately before, after and during local anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start4 May 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Mustafa AŞAR, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398105
- Sponsor's protocol ID
- SBAE Thesis Project
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety and Pain Control During Local Anesthesia in Children
- ClinicalTrials.gov ID
- NCT07398105
- Acronym / sponsor ID
- SBAE Thesis Project
- Conditions
- Dental Anxiety
- Keywords
- Pediatric Dentistry, Virtual Reality, Mixed Reality, Dental Anxiety, Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 4 May 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Group | Other | Behavioral: Audiovisual Distraction Using Head-Mounted DisplayChildren 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. |
| Mixed Reality (MR) Group | Other | Behavioral: Audiovisual Distraction Using Head-Mounted DisplayChildren 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual Distraction Using Head-Mounted DisplayParticipants 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. | Behavioural | Mixed Reality (MR) Group, Virtual Reality (VR) Group |
Primary outcome
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.
3 secondary outcomes
Pain Perception During Local Anesthesia
Time frame: During local anesthesia administration
Behavioral Pain Response Assessed by FLACC Scale
Time frame: During local anesthesia administration
Heart Rate Changes During Local Anesthesia
Time frame: Immediately before, after and during local anesthesia administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Distraction Using Head-Mounted Display in people with Dental Anxiety, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dental Anxiety Level During Local Anesthesia (time frame: Immediately before and during local anesthesia administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.