<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/NCT03229720</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol CairoU</org_study_id>
    <nct_id>NCT03229720</nct_id>
  </id_info>
  <brief_title>Evaluation of Audio-Visual Distraction Technique on Child's Anxiety</brief_title>
  <official_title>Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market&#xD;
      technology for adults and children. Some practitioners started using this modality of&#xD;
      distraction in the dental practice to aid in psychological management of patients.&#xD;
&#xD;
      This study is designed to compare between conventional dental visits (No Distraction) and&#xD;
      dental visits aided with audio-visual distraction. Providing a safe, comfortable and&#xD;
      entertaining dental environment will give pediatric children a better perception regarding&#xD;
      the dental environment and motivate them for repetitive dental visits for better dental&#xD;
      health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental&#xD;
      treatment will be randomly selected according to the Intrusion and Extrusion Criteria.&#xD;
&#xD;
      [II] Intervention:&#xD;
&#xD;
      -Steps:&#xD;
&#xD;
        1. The operator will select the teeth; child must have decayed tooth requiring restorative&#xD;
           dental treatment.&#xD;
&#xD;
        2. The visit will be started by using the tell-show-do technique to explain the procedure.&#xD;
           After that the Facial Image Scale is validated to assess dental anxiety and will be&#xD;
           explained to the child. The dentist will ask the child to choose one of the six faces&#xD;
           that best represented his/her current emotional state.&#xD;
&#xD;
        3. Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.&#xD;
&#xD;
        4. Patient will choose from a bowl a piece of paper to decide if AV-distraction will be&#xD;
           used or not.&#xD;
&#xD;
        5. Above steps will be done in both visits, with and without the intervention.&#xD;
&#xD;
        6. If the toss had AV-distraction, The operator will introduce the Audio-visual device&#xD;
           (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient&#xD;
           to choose his favorite show to watch during the dental visit.&#xD;
&#xD;
        7. The operator will instruct the patient with the rules that will be applied during the&#xD;
           dental visit to assure complete cooperation.&#xD;
&#xD;
        8. The operator will apply topical and dental anaesthesia&#xD;
&#xD;
        9. Pulse rate will be measured every 5 minutes.&#xD;
&#xD;
       10. The operator will allow extra time if the dental visit ended before the child finishes&#xD;
           the tv-show.&#xD;
&#xD;
       11. Then operator will ask the patient to choose from the face scale diagrams about his&#xD;
           anxiety state at the end of the visit.&#xD;
&#xD;
      Intervention modifications:&#xD;
&#xD;
      In case the child interrupted the dental visit for questions or any reason, the last record&#xD;
      of pulse oximeter will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The statistician is blinded by naming the groupes into group A and group B&#xD;
.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Facial Image Scale</measure>
    <time_frame>Immediately right after the dental visit.</time_frame>
    <description>To measure dental Anxiety by using Facial Image Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation (using Pulse oximetry)</measure>
    <time_frame>During the dental visit</time_frame>
    <description>to assess the amount of oxygen saturation and relate to the stress level.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Heart Rate (using Pulse oximetry)</measure>
    <time_frame>During the dental visit</time_frame>
    <description>to asses heart beats per minute and relate it to the patient's anxiety</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Anxiety, Dental</condition>
  <condition>Fear, Dental</condition>
  <arm_group>
    <arm_group_label>Audio-Visual Distraction Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Dental Environment Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal Dental Environment without any distractions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nibiru 3D Virtual Reality Headset</intervention_name>
    <description>This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.</description>
    <arm_group_label>Audio-Visual Distraction Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 5-8 years old.&#xD;
&#xD;
          -  Children with decayed teeth requiring pulp therapy (excluding cases with acute&#xD;
             pulpitis)&#xD;
&#xD;
          -  Cooperative children and potentially cooperative&#xD;
&#xD;
          -  Physically and mentally normal children.&#xD;
&#xD;
          -  No previous dental experience involving local anaesthetic administration for the last&#xD;
             2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with visual impairment.&#xD;
&#xD;
          -  Children with hearing disabilities.&#xD;
&#xD;
          -  Children with disability complicating the dental treatment as trismus, or TMJ&#xD;
             problems.&#xD;
&#xD;
          -  Children with highly inflamed pulp tissue inducing pain during dental visit.&#xD;
&#xD;
          -  Patients or caregivers who refuse to sign the consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Hamdy, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nada Wassef, Ass. Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherif A Zakhary, B.D.S</last_name>
    <phone>+2001224579366</phone>
    <email>Sherif_zakhary@hotmail.com</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sherif Adel Khalaf Zakhary</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Audio Visual Distraction</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>Undecided</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/NCT03229720
org study id: Protocol CairoU
nct id: NCT03229720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market
      technology for adults and children. Some practitioners started using this modality of
      distraction in the dental practice to aid in psychological management of patients.

      This study is designed to compare between conventional dental visits (No Distraction) and
      dental visits aided with audio-visual distraction. Providing a safe, comfortable and
      entertaining dental environment will give pediatric children a better perception regarding
      the dental environment and motivate them for repetitive dental visits for better dental
      health care.
[I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental
      treatment will be randomly selected according to the Intrusion and Extrusion Criteria.

      [II] Intervention:

      -Steps:

        1. The operator will select the teeth; child must have decayed tooth requiring restorative
           dental treatment.

        2. The visit will be started by using the tell-show-do technique to explain the procedure.
           After that the Facial Image Scale is validated to assess dental anxiety and will be
           explained to the child. The dentist will ask the child to choose one of the six faces
           that best represented his/her current emotional state.

        3. Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.

        4. Patient will choose from a bowl a piece of paper to decide if AV-distraction will be
           used or not.

        5. Above steps will be done in both visits, with and without the intervention.

        6. If the toss had AV-distraction, The operator will introduce the Audio-visual device
           (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient
           to choose his favorite show to watch during the dental visit.

        7. The operator will instruct the patient with the rules that will be applied during the
           dental visit to assure complete cooperation.

        8. The operator will apply topical and dental anaesthesia

        9. Pulse rate will be measured every 5 minutes.

       10. The operator will allow extra time if the dental visit ended before the child finishes
           the tv-show.

       11. Then operator will ask the patient to choose from the face scale diagrams about his
           anxiety state at the end of the visit.

      Intervention modifications:

      In case the child interrupted the dental visit for questions or any reason, the last record
      of pulse oximeter will be repeated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The statistician is blinded by naming the groupes into group A and group B
.
measure: Facial Image Scale
time frame: Immediately right after the dental visit.
description: To measure dental Anxiety by using Facial Image Scale
measure: Oxygen Saturation (using Pulse oximetry)
time frame: During the dental visit
description: to assess the amount of oxygen saturation and relate to the stress level.
measure: Heart Rate (using Pulse oximetry)
time frame: During the dental visit
description: to asses heart beats per minute and relate it to the patient's anxiety
arm group label: Audio-Visual Distraction Group
arm group type: Active Comparator
description: In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.
arm group label: Normal Dental Environment Group
arm group type: No Intervention
description: Normal Dental Environment without any distractions.
intervention type: Device
intervention name: Nibiru 3D Virtual Reality Headset
description: This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.
arm group label: Audio-Visual Distraction Group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Hamdy, Professor
role: Study Director
affiliation: Cairo University
last name: Nada Wassef, Ass. Prof
role: Study Chair
affiliation: Cairo University
last name: Sherif A Zakhary, B.D.S
phone: +2001224579366
email: Sherif_zakhary@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sherif Adel Khalaf Zakhary
investigator title: Principal Investigator
mesh term: Anxiety Disorders
sharing ipd: Undecided