Dental AnxietyNCT03486717
The Use of Virtual Reality Goggles
A study testing Virtual reality goggles in people with Dental Anxiety, run by Casey Goetz at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Virtual reality goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 21 Dec 2018
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry
Who cannot join
- History of dental anxiety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.
Read the detailed description
All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not.
At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.
- Conditions
- Dental Anxiety
- Being tested
- Virtual reality goggles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gogglesDevice
Patients will act as their own control over two different dental appointments. One appointment will consist of wearing the virtual reality googles, the other appointment will be conducted without them. The goggles have a small screen inside of them along with headphones. This device will play an a movie or cartoon that will immerse the patient during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Study group that does not wear the virtual reality goggles. This group will serve as a control. Receives: Device: Virtual reality goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported patient perception of pain
The patient will complete a self-reported pain scale known as the Wong-Baker Faces Pain Scale. This is a 1-10 pain scale that has correlating faces. A 1 indicates no pain, and correlates with a happy face. A 10 correlates with a crying face and indicates severe pain. A single number between 1-10 is selected to indicate the patient's pain.
Measured: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
Behavior of child
Behavior in terms of child cooperation will reported by an unbiased dental assistant using the Frankyl behavior scale. Behavior means the child listens to instructions and follows directions given by the clinician. This is a 1-4 scale, with 1 indicating extremely uncooperative behavior (crying, strong movement) and 4 indicating positive, cooperative behavior.
Measured: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 May 2018
- Primary completion20 Dec 2018
- Study completion21 Dec 2018
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.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casey Goetz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Casey Goetz, University of Iowa
- Investigators
- Casey Goetz, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486717
- Sponsor's protocol ID
- 201803829
- Status last verified
- Feb 2019
- First submitted
- 27 Mar 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
- ClinicalTrials.gov ID
- NCT03486717
- Acronym / sponsor ID
- 201803829
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Casey GoetzUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 3 Apr 2018 (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 purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.
Detailed description
All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not.
At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Virtual reality gogglesStudy group that does not wear the virtual reality goggles. This group will serve as a control. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry
Key exclusion criteria (1 listed)
- History of dental anxiety
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 gogglesPatients will act as their own control over two different dental appointments. One appointment will consist of wearing the virtual reality googles, the other appointment will be conducted without them. The goggles have a small screen inside of them along with headphones. This device will play an a movie or cartoon that will immerse the patient during treatment. | Device | Control |
Primary outcome
Self-reported patient perception of pain
Time frame: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
The patient will complete a self-reported pain scale known as the Wong-Baker Faces Pain Scale. This is a 1-10 pain scale that has correlating faces. A 1 indicates no pain, and correlates with a happy face. A 10 correlates with a crying face and indicates severe pain. A single number between 1-10 is selected to indicate the patient's pain.
Behavior of child
Time frame: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
Behavior in terms of child cooperation will reported by an unbiased dental assistant using the Frankyl behavior scale. Behavior means the child listens to instructions and follows directions given by the clinician. This is a 1-4 scale, with 1 indicating extremely uncooperative behavior (crying, strong movement) and 4 indicating positive, cooperative behavior.
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 15 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
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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.
Casey Goetz, DDS principal investigator
University of Iowa
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 goggles in people with Dental Anxiety, run by Casey Goetz 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 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 15 Feb 2019. 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?
Self-reported patient perception of pain (time frame: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)). 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 15 Feb 2019.