Clinical trial NCT04483336: Virtual Reality Distraction During Dental Local Anesthesia Among Children
Official title: Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Dental Fear
Keywords: Dental Anxiety
Dental Fear
Infiltration Dental Local Anesthesia
Virtual Reality
Dental Pain
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dental Pain measured using the Wong-Baker FACES Pain Rating Scale
timeFrame: 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.
measure: Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale
timeFrame: 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:
measure: Heart Rate(HR)
timeFrame: 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).
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
affiliation: King Abdulaziz University
name: Osama M Felemban, BDS, DScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.