Virtual Reality Distraction During Dental Local Anesthesia Among Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-30

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.

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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.

Conditions

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Dental Anxiety Dental Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

During the local anesthesia by the care provider, subjects in the test group had to wear VR goggles while control subjects watched a cartoon video on a TV screen. The pain and anxiety outcomes were assessed during the local anesthesia administration. Due to the nature of the study, it was not possible to mask the participants, care provider, or the outcome assessor. The investigator who statistically analyzed the data but was not involved in the dental procedures was masked to the group allocation.

Study Groups

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Virtual reality Distraction.

Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.

Group Type EXPERIMENTAL

Virtual Reality Distraction

Intervention Type OTHER

Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.

TV screen Distraction

Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.

Group Type ACTIVE_COMPARATOR

TV Screen Distraction

Intervention Type OTHER

A cartoon video was played on a regular TV screen.

Interventions

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Virtual Reality Distraction

Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.

Intervention Type OTHER

TV Screen Distraction

A cartoon video was played on a regular TV screen.

Intervention Type OTHER

Other Intervention Names

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LG 360 virtual reality [VR] headset, LG Electronics

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