Clinical Trials Directory

Trials / Completed

CompletedNCT04483336

Virtual Reality Distraction During Dental Local Anesthesia Among Children

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
King Abdulaziz University · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVirtual Reality DistractionVirtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
OTHERTV Screen DistractionA cartoon video was played on a regular TV screen.

Timeline

Start date
2019-03-01
Primary completion
2019-07-30
Completion
2019-07-30
First posted
2020-07-23
Last updated
2020-07-23

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT04483336. Inclusion in this directory is not an endorsement.