Virtual RealityVRGAMIFICATIONNCT06964451
Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients
A study testing Extraction tooth in people with Virtual Reality and Distraction, run by Rasa Mladenovic at 1 site in Serbia.
Trial summary
The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Virtual Reality, Distraction, Gamification
- What is being tested?
- Extraction tooth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jan 2022to 1 Jan 2024
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Indication for the extraction of both lower first molars due MIH grade 4.
Who cannot join
- Exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Faculty od Medical Sciences University of Kragujevac
Kragujevac, 34000
About this study
The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.
Read the detailed description
Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.
- Conditions
- Virtual Reality, Distraction, Gamification, Tooth Extraction
- Being tested
- Extraction tooth
- Keywords
- virtual reality, distraction, gamification, tooth extraction, MIH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction toothProcedure or surgery
Extraction of MIH Grade 4 molar
| Study group | Role | What they receive |
|---|---|---|
| NON VR | Active comparator | In the extraction of one tooth, the procedure was performed according to the standard protocol (Non VR Phase). Receives: Procedure: Extraction tooth |
| VR | Active comparator | For the tooth on the opposite side, the entire extraction procedure (including the application of local anesthesia) was conducted using a gamification model with VR goggles (VR Gamification Phase) Receives: Procedure: Extraction tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face Scale
We used the Wong-Baker Face Scale to assess pain, which allows patients to visually describe their level of pain. This scale consists of six faces with different expressions, ranging from a face showing no pain to a face representing the worst possible pain. This method of assessment is particularly useful for children. Pain was recorded during the administration of anaesthesia and during the tooth extraction procedure
Measured: 1 day
Heart rate
Additionally, heart rate was monitored to assess the patient's physiological response to stress and pain during the procedure. Heart rate was recorded during anaesthesia administration and during the procedure using a smartwatch that allows continuous heart rate tracking (Samsung Galaxy Watch). This type of measurement provides additional information on how the patient responds to pain and stress, enabling the dentist to adjust their approach according to the patient's physiological response.
Measured: 1 day
Secondary outcomes (1)
Satisfaction questionnaire
After the extraction procedure with VR application, patients filled out a modified satisfaction questionnaire. Responses were classified based on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The post-clinical questionnaire included questions related to reduction of fear of anaesthesia and extraction, effectiveness of VR in diverting attention from the procedure, experience of discomfort during the procedure, enjoyment of the VR experience, and the potential of VR in overcoming fear of other procedures.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasa Mladenovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasa Mladenovic, University of Kragujevac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964451
- Sponsor's protocol ID
- 01-14788/2022
- Other IDs
- Ethics Committee
- Acronym
- VRGAMIFICATION
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 9 May 2025
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06964451
- Acronym / sponsor ID
- VRGAMIFICATION / 01-14788/2022
- Conditions
- Virtual Reality, Distraction, Gamification, Tooth Extraction
- Keywords
- virtual reality, distraction, gamification, tooth extraction, MIH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rasa MladenovicUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 9 May 2025 (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.
The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.
Detailed description
Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON VR | Active comparator | Procedure: Extraction toothIn the extraction of one tooth, the procedure was performed according to the standard protocol (Non VR Phase). |
| VR | Active comparator | Procedure: Extraction toothFor the tooth on the opposite side, the entire extraction procedure (including the application of local anesthesia) was conducted using a gamification model with VR goggles (VR Gamification Phase) |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Indication for the extraction of both lower first molars due MIH grade 4.
Key exclusion criteria (1 listed)
- Exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.
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 |
|---|---|---|
| Extraction toothExtraction of MIH Grade 4 molar | Procedure or surgery | NON VR, VR |
Primary outcome
Face Scale
Time frame: 1 day
We used the Wong-Baker Face Scale to assess pain, which allows patients to visually describe their level of pain. This scale consists of six faces with different expressions, ranging from a face showing no pain to a face representing the worst possible pain. This method of assessment is particularly useful for children. Pain was recorded during the administration of anaesthesia and during the tooth extraction procedure
Heart rate
Time frame: 1 day
Additionally, heart rate was monitored to assess the patient's physiological response to stress and pain during the procedure. Heart rate was recorded during anaesthesia administration and during the procedure using a smartwatch that allows continuous heart rate tracking (Samsung Galaxy Watch). This type of measurement provides additional information on how the patient responds to pain and stress, enabling the dentist to adjust their approach according to the patient's physiological response.
1 secondary outcome
Satisfaction questionnaire
Time frame: 1 day
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 May 2025.
- Individual participant dataSharing planned: No
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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 Extraction tooth in people with Virtual Reality and Distraction, run by Rasa Mladenovic at 1 site in Serbia.
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 1 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 May 2025. 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 Serbia. 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?
Face Scale (time frame: 1 day). The study lists 2 primary outcomes in all. 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 May 2025.