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Completed

NCT Number: NCT04483336

Virtual Reality Distraction During Dental Local Anesthesia Among Children

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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Key information

Conditions

Dental Anxiety Dental Fear Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, 80209, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Distraction

Other

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

Other names: LG 360 virtual reality [VR] headset, LG Electronics

TV Screen Distraction

Other

A cartoon video was played on a regular TV screen.

Primary outcomes

  1. Dental Pain measured using the Wong-Baker FACES Pain Rating Scale

    Time frame: 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.

  2. Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale

    Time frame: 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 outcomes

  1. Heart Rate(HR)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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