<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/NCT03772483</url>
  </required_header>
  <id_info>
    <org_study_id>PlovdivMU2</org_study_id>
    <nct_id>NCT03772483</nct_id>
  </id_info>
  <brief_title>Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children</brief_title>
  <official_title>Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Plovdiv Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Plovdiv Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the efficacy of a virtual reality (VR) device in&#xD;
      reducing injection pain and anxiety associated with local anesthesia in pediatric dental&#xD;
      patients.&#xD;
&#xD;
      The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years&#xD;
      old requiring local anesthetic infiltration with conventional syringe (CS) for conservative&#xD;
      treatment of two primary maxillary molars bilaterally.&#xD;
&#xD;
      Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each,&#xD;
      whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome&#xD;
      measure will be pain felt during injection, reported by patient on visual analogue scale&#xD;
      (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS;&#xD;
      pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to&#xD;
      local anesthesia method - CS or CS+VR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achieving local anesthesia in children is one of the critical aspects of pain management.&#xD;
&#xD;
      A contemporary engaging form of distraction is represented by virtual reality devices.&#xD;
      Virtual reality (VR) devices create a virtual environment of view and sound that allow&#xD;
      patients to be immersed in an interactive, simulated world to distract them from pain. The VR&#xD;
      devices have a wide viewing field and three-dimensional displays that project the images&#xD;
      right in front of the user. They not only show potentially attractive audio-visual stimuli,&#xD;
      but also exclude all other visual environmental stimuli that may affect the patient.&#xD;
&#xD;
      The aim of this study is to determine the efficacy of a virtual reality (VR) device in&#xD;
      reducing injection pain and anxiety associated with local anesthesia in pediatric dental&#xD;
      patients.&#xD;
&#xD;
      The device used in this study is Noon VR, FXGear, compatible with a mobile phone.&#xD;
&#xD;
      The clinical trial is a randomized split-mouth assignment. Included patients are healthy&#xD;
      positive children 8-12 years old requiring local anesthetic infiltration for conservative&#xD;
      treatment of two primary maxillary molars bilaterally.&#xD;
&#xD;
      Eligible patients undergo two single-visit treatments after measurement of dental fear prior&#xD;
      to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS).&#xD;
      Local anesthetic is delivered through buccal infiltration with conventional syringe, where as&#xD;
      the virtual reality distraction is allocated to either first or second local anesthesia&#xD;
      procedure. Primary outcome measure will be pain felt during injection, reported by patient on&#xD;
      visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on&#xD;
      Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry,&#xD;
      Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia&#xD;
      method - traditional infiltration or virtual reality device-assisted injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 10, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized Intervention Model: Split-mouth assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain felt during injection using visual analogue scale</measure>
    <time_frame>Immediately after local anesthetic delivery</time_frame>
    <description>Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale</measure>
    <time_frame>During local anesthesia procedure</time_frame>
    <description>Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported anxiety during injection evaluated on FIS</measure>
    <time_frame>Immediately after local anesthetic delivery</time_frame>
    <description>The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate dynamics of the patient</measure>
    <time_frame>Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.</time_frame>
    <description>Patient's left index finger is connected to a portable recording pulse oximeter for children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of self-reported dental fear on CFSS-DS questionnaire</measure>
    <time_frame>At least 5 minutes before local anesthesia</time_frame>
    <description>Assessment will be performed prior to both visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient preference to local anesthesia method</measure>
    <time_frame>One week after second procedure</time_frame>
    <description>One week after the second dental visit, the patient is reached by a phone call and asked: &quot;Which method do you prefer to put your tooth to sleep? With the virtual reality device or without it?&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Injection Pain</condition>
  <condition>Local Anesthesia</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthesia with conventional syringe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthesia with conventional syringe + VR device</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local anesthesia with conventional syringe</intervention_name>
    <description>Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.&#xD;
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Local anesthesia with conventional syringe + VR device</intervention_name>
    <description>Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.&#xD;
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.&#xD;
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL</description>
    <arm_group_label>Virtual reality group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, identified as positive or definitely positive through Frankl behavioral&#xD;
             rating scale.&#xD;
&#xD;
          -  Children, requiring local anesthesia infiltration for conservative treatment of two&#xD;
             primary upper jaw molars bilaterally.&#xD;
&#xD;
          -  Children without previous experience with local anesthesia for dental treatment.&#xD;
&#xD;
          -  Obtained informed consent from parents or gave-givers to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are considered medically compromised or medically complex patients. The&#xD;
             absence of disease is confirmed by anamnestic interview with a parent or a care-giver&#xD;
             of the child and excludes general acute or chronic disease, cognitive impairment,&#xD;
             psychogenic non-epileptic events, sensitivity to flashing light or motion.&#xD;
&#xD;
          -  Vision requiring correction with eyeglasses.&#xD;
&#xD;
          -  Recent injury to the eyes or face that prevents comfortable use of VR hardware or&#xD;
             software.&#xD;
&#xD;
          -  Patients who are undergoing therapy with neurological, sedative, analgesic and/or&#xD;
             anti-inflammatory drugs 7 days prior to treatment.&#xD;
&#xD;
          -  Patients with allergy to local anesthetics of the amide group.&#xD;
&#xD;
          -  Children, who are first time ever dental patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elitsa Veneva, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Plovdiv Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatric Dentistry, Faculty of Dental Medicine</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>pain control</keyword>
  <keyword>pediatric dental patients</keyword>
  <keyword>pediatric pain management</keyword>
  <keyword>local anesthesia children</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03772483
org study id: PlovdivMU2
nct id: NCT03772483
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the efficacy of a virtual reality (VR) device in
      reducing injection pain and anxiety associated with local anesthesia in pediatric dental
      patients.

      The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years
      old requiring local anesthetic infiltration with conventional syringe (CS) for conservative
      treatment of two primary maxillary molars bilaterally.

      Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each,
      whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome
      measure will be pain felt during injection, reported by patient on visual analogue scale
      (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS;
      pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to
      local anesthesia method - CS or CS+VR.
Achieving local anesthesia in children is one of the critical aspects of pain management.

      A contemporary engaging form of distraction is represented by virtual reality devices.
      Virtual reality (VR) devices create a virtual environment of view and sound that allow
      patients to be immersed in an interactive, simulated world to distract them from pain. The VR
      devices have a wide viewing field and three-dimensional displays that project the images
      right in front of the user. They not only show potentially attractive audio-visual stimuli,
      but also exclude all other visual environmental stimuli that may affect the patient.

      The aim of this study is to determine the efficacy of a virtual reality (VR) device in
      reducing injection pain and anxiety associated with local anesthesia in pediatric dental
      patients.

      The device used in this study is Noon VR, FXGear, compatible with a mobile phone.

      The clinical trial is a randomized split-mouth assignment. Included patients are healthy
      positive children 8-12 years old requiring local anesthetic infiltration for conservative
      treatment of two primary maxillary molars bilaterally.

      Eligible patients undergo two single-visit treatments after measurement of dental fear prior
      to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS).
      Local anesthetic is delivered through buccal infiltration with conventional syringe, where as
      the virtual reality distraction is allocated to either first or second local anesthesia
      procedure. Primary outcome measure will be pain felt during injection, reported by patient on
      visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on
      Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry,
      Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia
      method - traditional infiltration or virtual reality device-assisted injection.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized Intervention Model: Split-mouth assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain felt during injection using visual analogue scale
time frame: Immediately after local anesthetic delivery
description: Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
measure: Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
time frame: During local anesthesia procedure
description: Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
measure: Self-reported anxiety during injection evaluated on FIS
time frame: Immediately after local anesthetic delivery
description: The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).
measure: Heart rate dynamics of the patient
time frame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
description: Patient's left index finger is connected to a portable recording pulse oximeter for children.
measure: Assessment of self-reported dental fear on CFSS-DS questionnaire
time frame: At least 5 minutes before local anesthesia
description: Assessment will be performed prior to both visits.
measure: Patient preference to local anesthesia method
time frame: One week after second procedure
description: One week after the second dental visit, the patient is reached by a phone call and asked: "Which method do you prefer to put your tooth to sleep? With the virtual reality device or without it?"
arm group label: Control group
arm group type: Active Comparator
description: Local anesthesia with conventional syringe
arm group label: Virtual reality group
arm group type: Active Comparator
description: Local anesthesia with conventional syringe + VR device
intervention type: Procedure
intervention name: Local anesthesia with conventional syringe
description: Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
arm group label: Control group
intervention type: Device
intervention name: Local anesthesia with conventional syringe + VR device
description: Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
arm group label: Virtual reality group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elitsa Veneva, DMD
role: Principal Investigator
affiliation: Plovdiv Medical University
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Anesthetics
sharing ipd: No