Virtual Reality Distraction During Dental Local Anesthesia Among Children

Not Applicable

Completed

• Conditions: Dental Fear; Dental Anxiety
• Interventions: Other: TV Screen Distraction; Other: Virtual Reality Distraction

• Registration Number: NCT04483336
• Lead Sponsor: King Abdulaziz University

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TV screen Distraction	TV Screen Distraction	Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.
Virtual reality Distraction.	Virtual Reality Distraction	Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.

Primary Outcome Measures

Name	Time	Method
Dental Pain measured using the Wong-Baker FACES Pain Rating Scale	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	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.

Secondary Outcome Measures

Name	Time	Method
Heart Rate(HR)	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).	Heart beats per minute measured using a pulse oximeter

Trial Locations

Locations (1)

King Abdulaziz University; 🇸🇦 Jeddah, Saudi Arabia