Pediatric DentistryNCT05890898
Virtual Reality vs Nitrous Oxide in Pediatric Dentistry
A study testing Virtual Reality Headset and Nitrous Oxide in people with Pediatric Dentistry, run by Geisinger Clinic at 1 site in United States.
Trial summary
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Dentistry
- What is being tested?
- Virtual Reality Headset and Nitrous Oxide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 20 Nov 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female pediatric dental patients age 4-12 years
- Require two restorative procedures that includes injection of anesthesia
- American Society of Anesthesiologists (ASA) physical status classification 1 or 2
Who cannot join
- Have health issues that prevent use of VR Oculus headset,
- Hypersensitivity to audio-visual devices that can lead to seizures
- ASA physical status classification 3 or 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality: An Interventional Study Comparing the Use of Virtual Reality to Nitrous Oxide for Analgesia During Dental Procedures on Pediatric Patients
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit where N2O will be used instead of VR. Procedures performed in all groups will be restorative treatments, which can include intraoral anesthetic injections, placing dental fillings, crowns, and the extractions of teeth. In group 1, A specific VR headset, the "Oculus Quest 2" will be used. Through the headset, a video will be played for the child during a dental procedure.
Read the detailed description
This is a prospective, randomized controlled, interventional therapy utilizing virtual reality goggles as a method of distraction. Data will be collected during and after the procedure on the type of behavior displayed and the child's response to standardized questions. Pediatric patients aged 4-12 years who only require nitrous sedation to complete painful dental treatment which necessitates anesthesia will be included in this study. These patients exhibit Frankl 2-3 behavior, requiring behavior guidance in order to complete the procedure. Frankl 1 or 4 children, those who do not need behavior guidance at all, or children with heavy behavior guidance who would not be able to complete the procedure, will be excluded.
Participants will be recruited in the clinic, during a new patient exam, routine hygiene or operative dentistry appointment. Following the Frankl behavior score diagnosis, an evaluation of behavior will happen during the beginning of the appointment, specifically watching for acceptance of treatment plan, openness to conversation, and any defiant behaviors or crying.
The parent and child being recruited for the study will be informed of the nature of the study, the possible risks benefit and alternatives, and written consent will be obtained from the parent or legal guardian. Assent from child 7 to 12 will also be required as well. The qualifying patient will enter the operatory and be admitted into the study. Participants will be briefed on how the study will proceed, and will be randomized into a control group or treatment group. The groups will be selected at random prior to treatment in the study. Both Groups will use of Faces, Legs, Arms, Crying Consolability(FLACC) Scale, WongBaker FACES, and Houpt Behavior scales to access the pain or discomfort of subjects. Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing. Each face has a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine. Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2. Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to console/comfort. Patients will be observed during the procedure using the Houpt Behavioral Scale. Each category is scored on the 0-2 scale which results in a total score of 0-10. Assessment of Behavioral Score: 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain.
Patients receiving N2O during their visit will follow the standard of care procedures. The VR goggles will be placed on the head and in front of the eyes. Patients using the goggles are automatically set to start media as soon as the wearer dons them. The patient will be reclined, and placed in an ideal setting, and the goggles will be calibrated to the patient's current view. The dental procedure will then follow. Most procedures require a local anesthetic injection, and if the patient receives this injection, participants will be graded with FLACC score during the injection. At the end of the procedure the child will be evaluated using the Wong-Baker FACES scale, the Houpt Crying and Movement Scales, and a survey will be given to the patient to be completed.
Participants will participate in the study during two restorative dental appointments, however, some patients may need more than two visits. Participants who require multiple restorative treatments will only being include in the study during first two visits and no other research activities will occur after. Most appointments are projected to last a maximum of 1 hour. The limiting factor in all treatment in this study, will be the participant's willingness to participate in future appointments.
- Conditions
- Pediatric Dentistry
- Being tested
- Virtual Reality Headset, Nitrous Oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetBehavioural
To determine if virtual reality headsets can reduce a patients pain level instead of using the standard Nitrous. This may provide a alternate to patients who cannot receive nitrous if pain or anxiety can be reduced effectively.
Nitrous OxideDrug
Nitrous Oxide is the current standard of care being used and will be compared to the use of the VR headsets.
| Study group | Role | What they receive |
|---|---|---|
| Control: Nitrous Oxide, then Virtual Reality Goggles | Experimental | Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. Receives: Behavioral: Virtual Reality Headset; Drug: Nitrous Oxide |
| Treatment: Virtual Reality Goggles, then Nitrous Oxide | Experimental | The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit under N2O will be used instead of VR. Receives: Behavioral: Virtual Reality Headset; Drug: Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of effectiveness virtual reality goggles reduce pain
To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The FLACC scale will be used to help measure this outcome.
Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2. Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to console/comfort.
Measured: 12 months
Rate of effectiveness virtual reality goggles reduce pain
To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The WongBaker scale will be used to help measure this outcome.
Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing. Each face has a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine.
Measured: 12 months
Secondary outcomes (1)
Rate of effectiveness of virtual reality distraction to nitrous oxide
To determine if there is a difference in the effectiveness between the use of the standard nitrous oxide and VR distraction. The Houpt scales will be used to help measure this outcome.
Patients will be observed during the procedure using the Houpt Behavioral Scale. Each category is scored on the 0-2 scale which results in a total score of 0-10. Assessment of Behavioral Score: 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start19 Sep 2023
- Primary completion5 Jul 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DentistryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890898
- Sponsor's protocol ID
- 2023-1000
- Status last verified
- Sep 2025
- First submitted
- 3 May 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality: An Interventional Study Comparing the Use of Virtual Reality to Nitrous Oxide for Analgesia During Dental Procedures on Pediatric Patients
- ClinicalTrials.gov ID
- NCT05890898
- Acronym / sponsor ID
- 2023-1000
- Conditions
- Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 6 Jun 2023 (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.
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit where N2O will be used instead of VR. Procedures performed in all groups will be restorative treatments, which can include intraoral anesthetic injections, placing dental fillings, crowns, and the extractions of teeth. In group 1, A specific VR headset, the "Oculus Quest 2" will be used. Through the headset, a video will be played for the child during a dental procedure.
Detailed description
This is a prospective, randomized controlled, interventional therapy utilizing virtual reality goggles as a method of distraction. Data will be collected during and after the procedure on the type of behavior displayed and the child's response to standardized questions. Pediatric patients aged 4-12 years who only require nitrous sedation to complete painful dental treatment which necessitates anesthesia will be included in this study. These patients exhibit Frankl 2-3 behavior, requiring behavior guidance in order to complete the procedure. Frankl 1 or 4 children, those who do not need behavior guidance at all, or children with heavy behavior guidance who would not be able to complete the procedure, will be excluded.
Participants will be recruited in the clinic, during a new patient exam, routine hygiene or operative dentistry appointment. Following the Frankl behavior score diagnosis, an evaluation of behavior will happen during the beginning of the appointment, specifically watching for acceptance of treatment plan, openness to conversation, and any defiant behaviors or crying.
The parent and child being recruited for the study will be informed of the nature of the study, the possible risks benefit and alternatives, and written consent will be obtained from the parent or legal guardian. Assent from child 7 to 12 will also be required as well. The qualifying patient will enter the operatory and be admitted into the study. Participants will be briefed on how the study will proceed, and will be randomized into a control group or treatment group. The groups will be selected at random prior to treatment in the study. Both Groups will use of Faces, Legs, Arms, Crying Consolability(FLACC) Scale, WongBaker FACES, and Houpt Behavior scales to access the pain or discomfort of subjects. Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing. Each face has a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine. Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2. Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to console/comfort. Patients will be observed during the procedure using the Houpt Behavioral Scale. Each category is scored on the 0-2 scale which results in a total score of 0-10. Assessment of Behavioral Score: 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain.
Patients receiving N2O during their visit will follow the standard of care procedures. The VR goggles will be placed on the head and in front of the eyes. Patients using the goggles are automatically set to start media as soon as the wearer dons them. The patient will be reclined, and placed in an ideal setting, and the goggles will be calibrated to the patient's current view. The dental procedure will then follow. Most procedures require a local anesthetic injection, and if the patient receives this injection, participants will be graded with FLACC score during the injection. At the end of the procedure the child will be evaluated using the Wong-Baker FACES scale, the Houpt Crying and Movement Scales, and a survey will be given to the patient to be completed.
Participants will participate in the study during two restorative dental appointments, however, some patients may need more than two visits. Participants who require multiple restorative treatments will only being include in the study during first two visits and no other research activities will occur after. Most appointments are projected to last a maximum of 1 hour. The limiting factor in all treatment in this study, will be the participant's willingness to participate in future appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Nitrous Oxide, then Virtual Reality Goggles | Experimental | Behavioral: Virtual Reality Headset, Drug: Nitrous OxideControl group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. |
| Treatment: Virtual Reality Goggles, then Nitrous Oxide | Experimental | Behavioral: Virtual Reality Headset, Drug: Nitrous OxideThe treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit under N2O will be used instead of VR. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female pediatric dental patients age 4-12 years
- Require two restorative procedures that includes injection of anesthesia
- American Society of Anesthesiologists (ASA) physical status classification 1 or 2
Key exclusion criteria (3 listed)
- Have health issues that prevent use of VR Oculus headset,
- Hypersensitivity to audio-visual devices that can lead to seizures
- ASA physical status classification 3 or 4
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 |
|---|---|---|
| Virtual Reality HeadsetTo determine if virtual reality headsets can reduce a patients pain level instead of using the standard Nitrous. This may provide a alternate to patients who cannot receive nitrous if pain or anxiety can be reduced effectively. | Behavioural | Control: Nitrous Oxide, then Virtual Reality Goggles, Treatment: Virtual Reality Goggles, then Nitrous Oxide |
| Nitrous OxideNitrous Oxide is the current standard of care being used and will be compared to the use of the VR headsets. | Drug | Control: Nitrous Oxide, then Virtual Reality Goggles, Treatment: Virtual Reality Goggles, then Nitrous Oxide |
Primary outcome
Rate of effectiveness virtual reality goggles reduce pain
Time frame: 12 months
To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The FLACC scale will be used to help measure this outcome. Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2. Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to console/comfort.
Rate of effectiveness virtual reality goggles reduce pain
Time frame: 12 months
To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The WongBaker scale will be used to help measure this outcome. Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing. Each face has a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine.
1 secondary outcome
Rate of effectiveness of virtual reality distraction to nitrous oxide
Time frame: 12 months
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 26 Sep 2025.
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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 Virtual Reality Headset and Nitrous Oxide in people with Pediatric Dentistry, run by Geisinger Clinic at 1 site in United States.
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 3 inclusion and 3 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 26 Sep 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 United States. 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?
Rate of effectiveness virtual reality goggles reduce pain (time frame: 12 months). 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 26 Sep 2025.