Virtual Reality Distraction During Dental Local Anesthesia Among Children
Primary Purpose
Dental Anxiety, Dental Fear
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Virtual Reality Distraction
TV Screen Distraction
Sponsored by
About this trial
This is an interventional supportive care trial for Dental Anxiety focused on measuring Dental Anxiety, Dental Fear, Infiltration Dental Local Anesthesia, Virtual Reality, Dental Pain
Eligibility 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
Sites / Locations
- King Abdulaziz University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual reality Distraction.
TV screen Distraction
Arm Description
Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.
Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Heart Rate(HR)
Heart beats per minute measured using a pulse oximeter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483336
Brief Title
Virtual Reality Distraction During Dental Local Anesthesia Among Children
Official Title
Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal infiltration anesthesia (BIA) in pediatric patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Dental Fear
Keywords
Dental Anxiety, Dental Fear, Infiltration Dental Local Anesthesia, Virtual Reality, Dental Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
Masking
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.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality Distraction.
Arm Type
Experimental
Arm Description
Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.
Arm Title
TV screen Distraction
Arm Type
Active Comparator
Arm Description
Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Distraction
Other Intervention Name(s)
LG 360 virtual reality [VR] headset, LG Electronics
Intervention Description
Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
Intervention Type
Other
Intervention Name(s)
TV Screen Distraction
Intervention Description
A cartoon video was played on a regular TV screen.
Primary Outcome Measure Information:
Title
Dental Pain measured using the Wong-Baker FACES Pain Rating Scale
Description
Wong-Baker FACES Pain Rating Scale is a six point scale (0, 2, 4, 6, 8, 10) where higher scores indicate worse pain.
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.
Title
Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale
Description
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.
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.
Secondary Outcome Measure Information:
Title
Heart Rate(HR)
Description
Heart beats per minute measured using a pulse oximeter
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama M Felemban, BDS, DScD
Organizational Affiliation
King Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdulaziz University
City
Jeddah
ZIP/Postal Code
80209
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34172032
Citation
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.
Results Reference
derived
Learn more about this trial
Virtual Reality Distraction During Dental Local Anesthesia Among Children
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