Virtual Reality Distraction During Dental Local Anesthesia Among Children

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483336
• Other study ID #: 07072020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: July 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Dental Fear

Intervention

Other:
• Virtual Reality Distraction
Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
• TV Screen Distraction
A cartoon video was played on a regular TV screen.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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).