<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04483336</url>
  </required_header>
  <id_info>
    <org_study_id>07072020</org_study_id>
    <nct_id>NCT04483336</nct_id>
  </id_info>
  <brief_title>Virtual Reality Distraction During Dental Local Anesthesia Among Children</brief_title>
  <official_title>Effect of Virtual Reality Distraction on Pain and Anxiety During Infiltration Anesthesia in Pediatric Patients: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal&#xD;
      infiltration anesthesia (BIA) in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design and Participants: This randomized clinical trial was conducted including healthy, and&#xD;
      cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local&#xD;
      anesthesia who are currently in need of nonemergency dental treatment under local anesthetic&#xD;
      infiltration by one of the postgraduate or interns at the pediatric dentistry students, were&#xD;
      eligible for the study. Patients with history of epilepsy and anxiety disorder were excluded&#xD;
      from the study&#xD;
&#xD;
      Methods and Material: In the test group, subjects received BIA while being distracted using&#xD;
      VR goggles; in the control group, subjects watched a cartoon video on a regular screen.&#xD;
      Subjects' heart rate (HR) was measured at baseline and at four different timepoints during&#xD;
      BIA administration to assess anxiety. The face, legs, activity, cry, consolability (FLACC)&#xD;
      Behavioral Pain Assessment Scale was scored by two calibrated investigators to assess pain.&#xD;
      After BIA, subjects rated their pain using the Arabic version of Wong-Baker FACES Pain Rating&#xD;
      Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dental Pain measured using the Wong-Baker FACES Pain Rating Scale</measure>
    <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.</time_frame>
    <description>Wong-Baker FACES Pain Rating Scale is a six point scale (0, 2, 4, 6, 8, 10) where higher scores indicate worse pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental Pain and Behavior measured using Face, Legs, Activity, Cry, Consolability (FLACC ) Behavioral Pain Assessment Scale</measure>
    <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.</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate(HR)</measure>
    <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).</time_frame>
    <description>Heart beats per minute measured using a pulse oximeter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Dental Anxiety</condition>
  <condition>Dental Fear</condition>
  <arm_group>
    <arm_group_label>Virtual reality Distraction.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TV screen Distraction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects watched a video cartoon on a regular TV screen as a distraction technique during the administration of local anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Reality Distraction</intervention_name>
    <description>Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.</description>
    <arm_group_label>Virtual reality Distraction.</arm_group_label>
    <other_name>LG 360 virtual reality [VR] headset, LG Electronics</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TV Screen Distraction</intervention_name>
    <description>A cartoon video was played on a regular TV screen.</description>
    <arm_group_label>TV screen Distraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  6-12-year-old children&#xD;
&#xD;
          -  Cooperative during dental treatments&#xD;
&#xD;
          -  In need of nonemergency dental treatment under local anesthetic infiltration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy and/or sensitivity to local anesthesia&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Anxiety Disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osama M Felemban, BDS, DScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdulaziz University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Abdulaziz University</name>
      <address>
        <city>Jeddah</city>
        <zip>80209</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Osama M Felemban</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dental Anxiety</keyword>
  <keyword>Dental Fear</keyword>
  <keyword>Infiltration Dental Local Anesthesia</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Dental Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04483336
org study id: 07072020
nct id: NCT04483336
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal
      infiltration anesthesia (BIA) in pediatric patients.
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.
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.
primary purpose: Supportive Care
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.
measure: 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.
description: Wong-Baker FACES Pain Rating Scale is a six point scale (0, 2, 4, 6, 8, 10) where higher scores indicate worse pain.
measure: 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.
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.
measure: 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).
description: Heart beats per minute measured using a pulse oximeter
arm group label: Virtual reality Distraction.
arm group type: Experimental
description: Subjects watched a video cartoon using virtual reality goggles as a distraction technique during the administration of local anesthesia.
arm group label: TV screen Distraction
arm group type: Active Comparator
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: Virtual Reality Distraction
description: Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
arm group label: Virtual reality Distraction.
other name: LG 360 virtual reality [VR] headset, LG Electronics
intervention type: Other
intervention name: TV Screen Distraction
description: A cartoon video was played on a regular TV screen.
arm group label: TV screen Distraction
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Osama M Felemban, BDS, DScD
role: Principal Investigator
affiliation: King Abdulaziz University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Osama M Felemban
investigator title: Assistant Professor
mesh term: Anxiety Disorders
sharing ipd: No