Dental AnxietyNCT04483336
Virtual Reality Distraction During Dental Local Anesthesia Among Children
A study testing Virtual Reality Distraction and TV Screen Distraction in people with Dental Anxiety and Dental Fear, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Anxiety, Dental Fear
- What is being tested?
- Virtual Reality Distraction and TV Screen Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2019to 30 Jul 2019
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy
- 6-12-year-old children
- Cooperative during dental treatments
- In need of nonemergency dental treatment under local anesthetic infiltration
Who cannot join
- Allergy and/or sensitivity to local anesthesia
- Epilepsy
- Anxiety Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial
To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients.
Read the detailed description
Design and Participants: This randomized clinical trial was conducted including healthy, and cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local anesthesia who are currently in need of nonemergency dental treatment under local anesthetic infiltration by one of the postgraduate or interns at the pediatric dentistry students, were eligible for the study. Patients with history of epilepsy and anxiety disorder were excluded from the study
Methods and Material: In the test group, subjects received BIA while being distracted using VR goggles; in the control group, subjects watched a cartoon video on a regular screen. Subjects' heart rate (HR) was measured at baseline and at four different timepoints during BIA administration to assess anxiety. The face, legs, activity, cry, consolability (FLACC) Behavioral Pain Assessment Scale was scored by two calibrated investigators to assess pain. After BIA, subjects rated their pain using the Arabic version of Wong-Baker FACES Pain Rating Scale.
- Conditions
- Dental Anxiety, Dental Fear
- Being tested
- Virtual Reality Distraction, TV Screen Distraction
- Keywords
- Dental Anxiety, Dental Fear, Infiltration Dental Local Anesthesia, Virtual Reality, Dental Pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionOther
Also called LG 360 virtual reality [VR] headset, LG Electronics
Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
TV Screen DistractionOther
A cartoon video was played on a regular TV screen.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality Distraction. | Experimental | Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia. Receives: Other: Virtual Reality Distraction |
| TV screen Distraction | Active comparator | Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia. Receives: Other: TV Screen Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Pain measured using the Wong-Baker FACES Pain Rating Scale
Wong-Baker FACES Pain Rating Scale is a six point scale (0, 2, 4, 6, 8, 10) where higher scores indicate worse pain.
Measured: Immediately after the local anesthesia administration, subjects were put in an upright position and asked to rate their pain using a validated Arabic version of Wong-Baker FACES Pain Rating Scale.
Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale
Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale scores range from 0 to 10 where higher scores indicate more severe pain and discomfort.
Measured: Throughout the procedure of local anesthesia administration (which is approximately 8 minutes long), FLACC Scale was recorded by two trained and calibrated investigators independently.
Secondary outcomes (1)
Heart Rate(HR)
Heart beats per minute measured using a pulse oximeter
Measured: HR was recorded 5 times: 1) once subject is on the dental chair; 2) video on (about 3 min later); 3) topical anesthesia (about 2 min later); 4) needle insertion (about 2 min later); 5) immediately after local anesthesia is complete (about 1 min later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama M Felemban, King Abdulaziz University
- Investigators
- Osama M Felemban, BDS, DScD, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483336
- Sponsor's protocol ID
- 07072020
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.
PubMed 34172032
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04483336
- Acronym / sponsor ID
- 07072020
- Conditions
- Dental Anxiety, Dental Fear
- Keywords
- Dental Anxiety, Dental Fear, Infiltration Dental Local Anesthesia, Virtual Reality, Dental Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 23 Jul 2020 (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.
To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients.
Detailed description
Design and Participants: This randomized clinical trial was conducted including healthy, and cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local anesthesia who are currently in need of nonemergency dental treatment under local anesthetic infiltration by one of the postgraduate or interns at the pediatric dentistry students, were eligible for the study. Patients with history of epilepsy and anxiety disorder were excluded from the study
Methods and Material: In the test group, subjects received BIA while being distracted using VR goggles; in the control group, subjects watched a cartoon video on a regular screen. Subjects' heart rate (HR) was measured at baseline and at four different timepoints during BIA administration to assess anxiety. The face, legs, activity, cry, consolability (FLACC) Behavioral Pain Assessment Scale was scored by two calibrated investigators to assess pain. After BIA, subjects rated their pain using the Arabic version of Wong-Baker FACES Pain Rating Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality Distraction. | Experimental | Other: Virtual Reality DistractionSubjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia. |
| TV screen Distraction | Active comparator | Other: TV Screen DistractionSubjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy
- 6-12-year-old children
- Cooperative during dental treatments
- In need of nonemergency dental treatment under local anesthetic infiltration
Key exclusion criteria (3 listed)
- Allergy and/or sensitivity to local anesthesia
- Epilepsy
- Anxiety Disorder
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 DistractionAlso: LG 360 virtual reality [VR] headset, LG ElectronicsVirtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally. | Other | Virtual reality Distraction. |
| TV Screen DistractionA cartoon video was played on a regular TV screen. | Other | TV screen Distraction |
Primary outcome
Dental Pain measured using the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after the local anesthesia administration, subjects were put in an upright position and asked to rate their pain using a validated Arabic version of Wong-Baker FACES Pain Rating Scale.
Wong-Baker FACES Pain Rating Scale is a six point scale (0, 2, 4, 6, 8, 10) where higher scores indicate worse pain.
Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale
Time frame: Throughout the procedure of local anesthesia administration (which is approximately 8 minutes long), FLACC Scale was recorded by two trained and calibrated investigators independently.
Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale scores range from 0 to 10 where higher scores indicate more severe pain and discomfort.
1 secondary outcome
Heart Rate(HR)
Time frame: HR was recorded 5 times: 1) once subject is on the dental chair; 2) video on (about 3 min later); 3) topical anesthesia (about 2 min later); 4) needle insertion (about 2 min later); 5) immediately after local anesthesia is complete (about 1 min later).
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 23 Jul 2020.
- Derived from this study: PubMed 34172032Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.
- 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.
Osama M Felemban, BDS, DScD principal investigator
King Abdulaziz University
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 Distraction and TV Screen Distraction in people with Dental Anxiety and Dental Fear, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 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 23 Jul 2020. 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 Saudi Arabia. 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?
Dental Pain measured using the Wong-Baker FACES Pain Rating Scale (time frame: Immediately after the local anesthesia administration, subjects were put in an upright position and asked to rate their pain using a validated Arabic version of Wong-Baker FACES Pain Rating Scale.). 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?
On the ClinicalTrials.gov record for NCT04483336, which also lists 1 linked publication.
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 23 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.