Virtual Reality Distraction During Dental Local Anesthesia Among Children

Study Overview
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Brief Summary
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To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients.

Detailed Description
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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.

Official Title
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Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial

Conditions
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Dental Anxiety, Dental Fear

Intervention / Treatment
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* Other: Virtual Reality Distraction
* Other: TV Screen Distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy 6-12-year-old children Cooperative during dental treatments In need of nonemergency dental treatment under local anesthetic infiltration Exclusion Criteria: Allergy and/or sensitivity to local anesthesia Epilepsy Anxiety Disorder

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality Distraction.<br>Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia. | Other: Virtual Reality Distraction<br>* Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.<br>* Other names: LG 360 virtual reality [VR] headset, LG Electronics;|
| Active Comparator: TV screen Distraction<br>Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia. | Other: TV Screen Distraction<br>* A cartoon video was played on a regular TV screen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate(HR) | Heart beats per minute measured using a pulse oximeter | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Anxiety, Dental Fear, Infiltration Dental Local Anesthesia, Virtual Reality, Dental Pain