Dental Anxiety in ChildrenVR-PEDNCT07781254
Immersive Virtual Reality for Pain and Dental Anxiety During Pediatric Restorative Treatment
A study testing Immersive Virtual Reality in people with Dental Anxiety in Children and Dental Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dental Anxiety in Children, Dental Pain, Virtual Reality
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 28 Aug 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Faculty of Dentistry
Gaziantep, 27310
About this study
Official title: Beyond Distraction: Effects of Immersive Virtual Reality on Pain, Dental Fear, Behavioral Cooperation, and Parental Satisfaction During Pediatric Restorative Treatment-A Randomized Controlled Trial
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.
Read the detailed description
This single-center, two-arm, parallel-group randomized controlled clinical trial evaluated the effects of immersive virtual reality (VR) distraction during restorative dental treatment in children aged 8-12 years.
Children requiring restorative treatment of mandibular second primary molars with occlusal carious lesions classified as ICDAS II codes 2-4 were eligible for participation. Eligible children were randomly assigned in a 1:1 ratio to either an immersive VR group or a control group. Randomization was performed using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes.
Children in the VR group used an immersive VR headset during the dental procedure and watched the same age-appropriate animated video throughout treatment. The headset was placed approximately one minute before administration of local anesthesia and remained in place until completion of the restorative procedure. Children in the control group received routine restorative dental treatment without a distraction intervention.
All dental procedures were performed by the same calibrated pediatric dentist according to a standardized clinical protocol. Local anesthesia was administered using an inferior alveolar nerve block with 1.8 mL of 2% lidocaine through a 30-gauge dental needle. The restorative procedure was performed on mandibular second primary molars and lasted approximately 10-15 minutes.
The primary outcome was children's pain perception, assessed using the Wong-Baker Faces Pain Rating Scale. Secondary outcomes included behavioral cooperation, dental anxiety, dental fear, emotional responses, physiological parameters, parent and clinician satisfaction, and treatment duration.
Pain was assessed during and immediately after treatment. Behavioral cooperation and physiological parameters were assessed before, during, and after treatment. Dental anxiety and emotional responses were assessed before and after treatment, while dental fear was evaluated using a validated questionnaire. Parent and clinician satisfaction were assessed immediately after treatment.
The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol received approval from the Sanko University Clinical Research Ethics Committee (KAEK-028-1). Written informed consent was obtained from the parents or legal guardians, and verbal assent was obtained from the participating children.
- Being tested
- Immersive Virtual Reality
- Keywords
- Virtual Reality, Pediatric dentistry, Dental fear, Pain perception, Behavior guidance, child
- Medical subject headings
- Toothache, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityBehavioural
Immersive virtual reality-based audiovisual distraction using a standardized, age-appropriate animated video during restorative dental treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Pain perception was assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS), with higher scores indicating greater pain intensity.
Measured: During treatment (T1) and immediately after completion of the restorative procedure (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start20 May 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Güner, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781254
- Sponsor's protocol ID
- KAEK-028-1
- Acronym
- VR-PED
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37948113Kasimoglu 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.
PubMed 39465519Barros 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.
PubMed 38087294Yan 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.
PubMed 36842625
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Distraction: Effects of Immersive Virtual Reality on Pain, Dental Fear, Behavioral Cooperation, and Parental Satisfaction During Pediatric Restorative Treatment-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07781254
- Acronym / sponsor ID
- VR-PED / KAEK-028-1
- Keywords
- Virtual Reality, Pediatric dentistry, Dental fear, Pain perception, Behavior guidance, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 24 Aug 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.
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.
Detailed description
This single-center, two-arm, parallel-group randomized controlled clinical trial evaluated the effects of immersive virtual reality (VR) distraction during restorative dental treatment in children aged 8-12 years.
Children requiring restorative treatment of mandibular second primary molars with occlusal carious lesions classified as ICDAS II codes 2-4 were eligible for participation. Eligible children were randomly assigned in a 1:1 ratio to either an immersive VR group or a control group. Randomization was performed using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes.
Children in the VR group used an immersive VR headset during the dental procedure and watched the same age-appropriate animated video throughout treatment. The headset was placed approximately one minute before administration of local anesthesia and remained in place until completion of the restorative procedure. Children in the control group received routine restorative dental treatment without a distraction intervention.
All dental procedures were performed by the same calibrated pediatric dentist according to a standardized clinical protocol. Local anesthesia was administered using an inferior alveolar nerve block with 1.8 mL of 2% lidocaine through a 30-gauge dental needle. The restorative procedure was performed on mandibular second primary molars and lasted approximately 10-15 minutes.
The primary outcome was children's pain perception, assessed using the Wong-Baker Faces Pain Rating Scale. Secondary outcomes included behavioral cooperation, dental anxiety, dental fear, emotional responses, physiological parameters, parent and clinician satisfaction, and treatment duration.
Pain was assessed during and immediately after treatment. Behavioral cooperation and physiological parameters were assessed before, during, and after treatment. Dental anxiety and emotional responses were assessed before and after treatment, while dental fear was evaluated using a validated questionnaire. Parent and clinician satisfaction were assessed immediately after treatment.
The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol received approval from the Sanko University Clinical Research Ethics Committee (KAEK-028-1). Written informed consent was obtained from the parents or legal guardians, and verbal assent was obtained from the participating children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Immersive Virtual RealityParticipants 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. |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Immersive Virtual RealityImmersive virtual reality-based audiovisual distraction using a standardized, age-appropriate animated video during restorative dental treatment. | Behavioural | Virtual Reality Group |
Primary outcome
Pain Perception
Time frame: During treatment (T1) and immediately after completion of the restorative procedure (T2)
Pain perception was assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS), with higher scores indicating greater pain intensity.
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 24 Aug 2026.
- Background: PubMed 37948113Wu 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.
- Background: PubMed 39465519Kasimoglu 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.
- Background: PubMed 38087294Barros 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.
- Background: PubMed 36842625Yan 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.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety in Children
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, 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 Immersive Virtual Reality in people with Dental Anxiety in Children and Dental Pain, run by University of Gaziantep 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 1 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 24 Aug 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?
Pain Perception (time frame: During treatment (T1) and immediately after completion of the restorative procedure (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781254, which also lists 4 linked publications.
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 24 Aug 2026.