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Virtual Reality Distraction During Dental Local Anesthesia Among Children

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ClinicalTrials.gov Identifier: NCT04483336
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Osama M Felemban, 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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Dental Fear Other: Virtual Reality Distraction Other: TV Screen Distraction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Virtual reality Distraction.
Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.
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.
Other Name: LG 360 virtual reality [VR] headset, LG Electronics

Active Comparator: TV screen Distraction
Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.
Other: TV Screen Distraction
A cartoon video was played on a regular TV screen.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483336


Locations
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Saudi Arabia
King Abdulaziz University
Jeddah, Saudi Arabia, 80209
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Osama M Felemban, BDS, DScD King Abdulaziz University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Osama M Felemban, Assistant Professor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT04483336    
Other Study ID Numbers: 07072020
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osama M Felemban, King Abdulaziz University:
Dental Anxiety
Dental Fear
Infiltration Dental Local Anesthesia
Virtual Reality
Dental Pain
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders