xml: <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/NCT05963750</url>
    </required_header>
    <id_info>
      <org_study_id>21-0188</org_study_id>
      <nct_id>NCT05963750</nct_id>
    </id_info>
    <brief_title>Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia</brief_title>
    <acronym>REVIDEN</acronym>
    <official_title>Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</source>
    <oversight_info>
      <has_dmc>No</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>
        Fear of the dentist is a very common phenomenon which delays consultations and brings&#xD;
        negative consequences on oral and general health. Virtual reality (VR) reduces children's&#xD;
        pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized&#xD;
        and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a&#xD;
        sample of adults during tooth avulsions under local anesthesia. There is a group with virtual&#xD;
        reality and a control group without virtual reality.&#xD;
  &#xD;
        Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the&#xD;
        visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the&#xD;
        anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA&#xD;
        score before vs during the surgery. Secondary criteria are the relevance of the chosen metric&#xD;
        by comparing it to the VAS, defining the factors influencing the evolution of the anxiety&#xD;
        score, studying the side effects of VR and the wish to repeat the experience.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The virtual reality experience consisted of putting on a headset with music and a 3D helmet&#xD;
        on the eyes that broadcast a landscape in motion (a walk).&#xD;
  &#xD;
        The inclusion took place in the University Hospital of Caen between november 2021 and may&#xD;
        2022.&#xD;
  &#xD;
        119 patients were randomized into two groups, one with VR and another one without VR. At the&#xD;
        end, 105 patients were analyzed.&#xD;
  &#xD;
        The main objective was to find a reduction in the STAI-YA score of more than 8 points between&#xD;
        before and during the intervention. This analysis was performed in both groups.&#xD;
  &#xD;
        During the initial consultation, questions were asked about the medical file and informed&#xD;
        consent was sought. Patients were then randomised to one of two groups.&#xD;
  &#xD;
        During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then&#xD;
        the intervention was performed with or without virtual reality, depending on the group, and&#xD;
        the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress&#xD;
        experienced during the surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 2, 2021</start_date>
    <completion_date type="Actual">July 30, 2022</completion_date>
    <primary_completion_date type="Actual">April 30, 2022</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>A list with numbers from 1 to 120 was produced prior to the study on Excel. Each number was assigned a random group (with and without VR).&#xD;
  During the first consultation, the patient was assigned a number (the practitioner followed the list on Excel) and therefore a group. Both practitioner and patient knew the patient's group for the next appointment.&#xD;
  When the patient filled out the questionnaires, he was referring to his assigned number and not his name. Then, the practitioner filled in the Excel file with the data collected (characteristics of the patients, STAI-YA score, VAS), which were associated with the patient's number, and which were therefore anonymous.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>effectiveness of virtual reality on anxiety (STAI-YA)</measure>
      <time_frame>Baseline and during the procedure.</time_frame>
      <description>The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>effectiveness of virtual reality on anxiety (Visual Analogue Scale)</measure>
      <time_frame>Baseline and during the procedure.</time_frame>
      <description>The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparability of the results with another metric for assessing anxiety</measure>
      <time_frame>1 day of surgery</time_frame>
      <description>The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>factors influencing changes in the STAI-YA anxiety score</measure>
      <time_frame>1 day of surgery</time_frame>
      <description>Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The wish to renew the virtual reality experience</measure>
      <time_frame>1 day of surgery</time_frame>
      <description>the question &quot;would you like to repeat the experience for other dental avulsions&quot; was asked to the group who had benefited from virtual reality</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">119</enrollment>
    <condition>Tooth Avulsion</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>virtual reality during the surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group with the use of virtual reality during the surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group without the use of virtual reality during the surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>virtual reality</intervention_name>
      <description>virtual reality</description>
      <arm_group_label>virtual reality during the surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Adults (&gt; 18 years old) coming for at least two dental extractions under local anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients suffering of motion sickness,&#xD;
  &#xD;
            -  claustrophobia,&#xD;
  &#xD;
            -  uncontrolled epilepsy,&#xD;
  &#xD;
            -  visual impairment,&#xD;
  &#xD;
            -  hearing disability,&#xD;
  &#xD;
            -  non-French speakers,&#xD;
  &#xD;
            -  pregnant women,&#xD;
  &#xD;
            -  protected adults&#xD;
  &#xD;
            -  people followed by a psychiatrist whether for depression, bipolarity, schizophrenia&#xD;
  &#xD;
            -  The day of the intervention, patients who had consumed anxiolytics&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexis Veyssiere, M.D</last_name>
      <role>Study Director</role>
      <affiliation>CHU Caen</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Caen</name>
        <address>
          <city>Caen</city>
          <state>Normandie</state>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>virtual reality</keyword>
    <keyword>oral surgery</keyword>
    <keyword>anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth Avulsion</mesh_term>
      <mesh_term>Fractures, Avulsion</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>this is not planned</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963750
  org study id: 21-0188
  nct id: NCT05963750
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Fear of the dentist is a very common phenomenon which delays consultations and brings
        negative consequences on oral and general health. Virtual reality (VR) reduces children's
        pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized
        and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a
        sample of adults during tooth avulsions under local anesthesia. There is a group with virtual
        reality and a control group without virtual reality.
  
        Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the
        visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the
        anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA
        score before vs during the surgery. Secondary criteria are the relevance of the chosen metric
        by comparing it to the VAS, defining the factors influencing the evolution of the anxiety
        score, studying the side effects of VR and the wish to repeat the experience.
  The virtual reality experience consisted of putting on a headset with music and a 3D helmet
        on the eyes that broadcast a landscape in motion (a walk).
  
        The inclusion took place in the University Hospital of Caen between november 2021 and may
        2022.
  
        119 patients were randomized into two groups, one with VR and another one without VR. At the
        end, 105 patients were analyzed.
  
        The main objective was to find a reduction in the STAI-YA score of more than 8 points between
        before and during the intervention. This analysis was performed in both groups.
  
        During the initial consultation, questions were asked about the medical file and informed
        consent was sought. Patients were then randomised to one of two groups.
  
        During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then
        the intervention was performed with or without virtual reality, depending on the group, and
        the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress
        experienced during the surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A list with numbers from 1 to 120 was produced prior to the study on Excel. Each number was assigned a random group (with and without VR).
  During the first consultation, the patient was assigned a number (the practitioner followed the list on Excel) and therefore a group. Both practitioner and patient knew the patient's group for the next appointment.
  When the patient filled out the questionnaires, he was referring to his assigned number and not his name. Then, the practitioner filled in the Excel file with the data collected (characteristics of the patients, STAI-YA score, VAS), which were associated with the patient's number, and which were therefore anonymous.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: effectiveness of virtual reality on anxiety (STAI-YA)
  time frame: Baseline and during the procedure.
  description: The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
  measure: effectiveness of virtual reality on anxiety (Visual Analogue Scale)
  time frame: Baseline and during the procedure.
  description: The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.
  measure: Comparability of the results with another metric for assessing anxiety
  time frame: 1 day of surgery
  description: The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.
  measure: factors influencing changes in the STAI-YA anxiety score
  time frame: 1 day of surgery
  description: Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
  measure: The wish to renew the virtual reality experience
  time frame: 1 day of surgery
  description: the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality
  arm group label: virtual reality during the surgery
  arm group type: Experimental
  description: Group with the use of virtual reality during the surgery
  arm group label: control
  arm group type: No Intervention
  description: Group without the use of virtual reality during the surgery
  intervention type: Other
  intervention name: virtual reality
  description: virtual reality
  arm group label: virtual reality during the surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexis Veyssiere, M.D
  role: Study Director
  affiliation: CHU Caen
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Tooth Avulsion
  mesh term: Fractures, Avulsion
  mesh term: Anxiety Disorders
  sharing ipd: No
  ipd description: this is not planned