Pediatric DentistryNCT04886141
Virtual Reality and Anxiety in Pediatric Dentistry
A study testing Virtual Reality Headset 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. The treatment group will receive dental treatment while wearing Virtual reality Headset. Control group will receive the standard of care dental treatment with under nitrous sedation. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 21 Apr 2022
- 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 a restorative procedure that includes injection of anesthesia .
- Exhibiting behavior Frankel 2 or 3 during their new patient, recall or previous dental appointment.
- ASA 1 or 1
Who cannot join
- Children who exhibit behavior rated as Frankl 1, or Frankl 4.
- Have health issues that prevent use of VR Oculus headset,
- Hypersensitivity to audio-visual devices that can lead to seizures
- ASA 3 or 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality and Pediatric Dentistry: An Interventional Study Examining Distraction Comparing Virtual Reality Goggles to Nitrous Oxide During Dental Procedures
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. The treatment group will receive dental treatment while wearing Virtual reality Headset. Control group will receive the standard of care dental treatment with under nitrous sedation. 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 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. If the child had previously presented as Frankl 2-3 within 6 months of the day of screening, the child may be considered for the study.
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, (continuing a typical procedure using nitrous oxide ), or treatment group (continuing a procedure with the VR goggles). The groups will be selected at random prior to treatment in the study, using the flip of a coin. Both Groups will use of FLACC, Wong-Baker FACES, and Houpt Behavior scales to access the pain or discomfort of subjects. The treatment group will have the goggles placed on the head and in front of the eyes. 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 a restorative dental appointment, however, some patients may need more the one restorative visit. Participants who require multiple restorative treatments will only being include in the study during one visit 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care treatment with Scales | No intervention | Patients will receive the standard of care restorative procedure with the addition of the FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale to create a baseline data of pain to compare with the experimental group. |
| Virtual Reality Headset | Experimental | Instead of receiving the Nitrous that would be used to help calm patients during the standard of care restorative procedure. Patients will be given a the Oculus Quest 2 Virtual realty headset and a video will be played. The FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale data will be collected to compare the patients pain level between the two groups. Receives: Behavioral: Virtual Reality Headset |
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 if pain can be diminished or alleviated and if subjects had better cooperation or pain tolerance with the distraction through virtual reality headsets.
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.
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 posted13 May 2021
- Study start21 Oct 2021
- Primary completion1 Apr 2022
- Study completion21 Apr 2022
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayatri Malik, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886141
- Sponsor's protocol ID
- 2021-0138
- Status last verified
- Aug 2022
- First submitted
- 6 May 2021
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Pediatric Dentistry: An Interventional Study Examining Distraction Comparing Virtual Reality Goggles to Nitrous Oxide During Dental Procedures
- ClinicalTrials.gov ID
- NCT04886141
- Acronym / sponsor ID
- 2021-0138
- Conditions
- Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 13 May 2021 (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. The treatment group will receive dental treatment while wearing Virtual reality Headset. Control group will receive the standard of care dental treatment with under nitrous sedation. 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 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. If the child had previously presented as Frankl 2-3 within 6 months of the day of screening, the child may be considered for the study.
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, (continuing a typical procedure using nitrous oxide ), or treatment group (continuing a procedure with the VR goggles). The groups will be selected at random prior to treatment in the study, using the flip of a coin. Both Groups will use of FLACC, Wong-Baker FACES, and Houpt Behavior scales to access the pain or discomfort of subjects. The treatment group will have the goggles placed on the head and in front of the eyes. 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 a restorative dental appointment, however, some patients may need more the one restorative visit. Participants who require multiple restorative treatments will only being include in the study during one visit 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care treatment with Scales | No intervention | –Patients will receive the standard of care restorative procedure with the addition of the FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale to create a baseline data of pain to compare with the experimental group. |
| Virtual Reality Headset | Experimental | Behavioral: Virtual Reality HeadsetInstead of receiving the Nitrous that would be used to help calm patients during the standard of care restorative procedure. Patients will be given a the Oculus Quest 2 Virtual realty headset and a video will be played. The FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale data will be collected to compare the patients pain level between the two groups. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female pediatric dental patients age 4-12 years
- Require a restorative procedure that includes injection of anesthesia .
- Exhibiting behavior Frankel 2 or 3 during their new patient, recall or previous dental appointment.
- ASA 1 or 1
Key exclusion criteria (4 listed)
- Children who exhibit behavior rated as Frankl 1, or Frankl 4.
- Have health issues that prevent use of VR Oculus headset,
- Hypersensitivity to audio-visual devices that can lead to seizures
- ASA 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 | Virtual Reality Headset |
Primary outcome
Rate of effectiveness virtual reality goggles reduce pain
Time frame: 12 months
To determine if pain can be diminished or alleviated and if subjects had better cooperation or pain tolerance with the distraction through virtual reality headsets.
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 4 Aug 2022.
Related trials for Pediatric Dentistry
Recruiting
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
Anesthesia, Local
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
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 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 4 inclusion and 4 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 4 Aug 2022. 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). 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 4 Aug 2022.