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
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety Dental Fear||Other: Virtual Reality Distraction Other: TV Screen Distraction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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 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|
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.
- 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.
- 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.
- 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
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
|King Abdulaziz University|
|Jeddah, Saudi Arabia, 80209|
|Principal Investigator:||Osama M Felemban, BDS, DScD||King Abdulaziz University|