Virtual Reality Distraction During Dental Local Anesthesia Among Children

NCT04483336 | Completed

• 1 other identifier: 07072020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety; Dental Fear

Keywords

Dental Anxiety; Dental Fear; Infiltration Dental Local Anesthesia; Virtual Reality; Dental Pain

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• 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).

Study Arms (2)

Virtual reality Distraction.

EXPERIMENTAL

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

Other: Virtual Reality Distraction

TV screen Distraction

ACTIVE COMPARATOR

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

Other: TV Screen Distraction

Interventions

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.

Also known as: LG 360 virtual reality [VR] headset, LG Electronics

Virtual reality Distraction.

TV Screen Distraction OTHER

A cartoon video was played on a regular TV screen.

TV screen Distraction

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy
• year-old children
• Cooperative during dental treatments
• In need of nonemergency dental treatment under local anesthetic infiltration

You may not qualify if:

• Allergy and/or sensitivity to local anesthesia
• Epilepsy
• Anxiety Disorder

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, 80209, Saudi Arabia

Location

Related Publications (1)

• Felemban OM, Alshamrani RM, Aljeddawi DH, Bagher SM. Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. BMC Oral Health. 2021 Jun 25;21(1):321. doi: 10.1186/s12903-021-01678-x.

  PMID: 34172032 DERIVED

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Osama M Felemban, BDS, DScD

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 23, 2020
• Study Start: March 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)