Dental ProceduresNCT03862573
Virtual Reality vs. Standard-of-Care for Comfort During Dental Procedures in Children
A study testing Virtual Reality in people with Dental Procedures, run by University of British Columbia at 1 site in Canada.
Trial summary
Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Dental Procedures
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2019to 31 Mar 2020
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 4 to < 17 years
- Arriving to the UBC dentistry clinic and need dental assessment/procedures
- Parents will sign a consent form and children will sign an assent form
Who cannot join
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication)
- Facial features prohibiting wearing the VR goggles
- Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC graduate pediatric dentistry clinic
Vancouver, British Columbia, V6T 1Z3
Ran D. Goldman, MD, 604-875-2345 ext. 7333, rgoldman@cw.bc.ca
Jennifer Park
About this study
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Dental Treatment
Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (4 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during dental procedures. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.
- Conditions
- Dental Procedures
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during the dental procedure Receives: Device: Virtual Reality |
| Control (Standard of Care) | No intervention | Participants are distracted with Standard-of-Care by dentists and/or parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Procedure Pain using the Faces Pain Scale - Revised
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
Measured: Pain is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete
Secondary outcomes (5)
Post Local Anesthetic Pain using the Faces Pain Scale - Revised
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
Measured: Pain is reported by children immediately following injection of the local anesthetic (within two minutes post-injection). This scale should take less than one minute to complete
Anxiety using the Venham Situational Anxiety Score
Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).
Measured: Anxiety is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete
Co-operation of the child as measured by the Dentist on 100mm VAS
The dentist will rate their impression of the level of co-operation by the child on a 100 mm VAS.
Measured: Co-operation is rated immediately following completion of the dental visit.
Patient Satisfaction determined qualitatively by an open ended question
Satisfaction from the procedure is determined qualitatively. Children are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
Measured: Satisfaction question is reported by children immediately following completion of the dental procedure
Parent Satisfaction determined qualitatively by an open ended question
Satisfaction from the procedure is determined qualitatively. Parents are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
Measured: Satisfaction question is reported by parents immediately following completion of the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start31 Mar 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProceduresStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Goldman, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862573
- Sponsor's protocol ID
- H19-00486
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Dental Treatment
- ClinicalTrials.gov ID
- NCT03862573
- Acronym / sponsor ID
- H19-00486
- Conditions
- Dental Procedures
- Keywords
- Virtual Reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 31 Mar 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Mar 2019 (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.
Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (4 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during dental procedures. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityParticipants are distracted by wearing the virtual reality headset and watching a roller coaster app during the dental procedure |
| Control (Standard of Care) | No intervention | –Participants are distracted with Standard-of-Care by dentists and/or parents. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children age 4 to < 17 years
- Arriving to the UBC dentistry clinic and need dental assessment/procedures
- Parents will sign a consent form and children will sign an assent form
Key exclusion criteria (3 listed)
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication)
- Facial features prohibiting wearing the VR goggles
- Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation
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 RealityParticipants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment. | Device | Virtual Reality |
Primary outcome
Post Procedure Pain using the Faces Pain Scale - Revised
Time frame: Pain is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
5 secondary outcomes
Post Local Anesthetic Pain using the Faces Pain Scale - Revised
Time frame: Pain is reported by children immediately following injection of the local anesthetic (within two minutes post-injection). This scale should take less than one minute to complete
Anxiety using the Venham Situational Anxiety Score
Time frame: Anxiety is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete
Co-operation of the child as measured by the Dentist on 100mm VAS
Time frame: Co-operation is rated immediately following completion of the dental visit.
Patient Satisfaction determined qualitatively by an open ended question
Time frame: Satisfaction question is reported by children immediately following completion of the dental procedure
Parent Satisfaction determined qualitatively by an open ended question
Time frame: Satisfaction question is reported by parents immediately following completion of the dental procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
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 in people with Dental Procedures, run by University of British Columbia at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 13 Mar 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran D. Goldman, MD (604-875-2345 ext. 7333, rgoldman@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Procedure Pain using the Faces Pain Scale - Revised (time frame: Pain is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete). 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 13 Mar 2019.