<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/NCT04453696</url>
  </required_header>
  <id_info>
    <org_study_id>KaradenizTU01</org_study_id>
    <nct_id>NCT04453696</nct_id>
  </id_info>
  <brief_title>Dentist-Patient Communication on Dental Anxiety Using the Social Media and Timing in Communication</brief_title>
  <official_title>Dentist-Patient Communication on Dental Anxiety Using the Social Media and Timing in Communication: A Double-blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Onur Yilmaz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pinar Sivrikaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karadeniz Technical 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>
      Scales application one week before and one week after impacted tooth extraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the present study was to assess the effects of dentist-patient communication&#xD;
      via social media on dental anxiety, and second, to evaluate the appropriate timing of such&#xD;
      communications.&#xD;
&#xD;
      Instagram's quick replies system was used to answer patients' questions to alleviate dental&#xD;
      anxiety for patients undergoing impacted mandibular third-molar extraction under local&#xD;
      anesthesia. Patients were assigned randomly into four groups according to timing of such&#xD;
      communications: Communication before operation (n=36), Communication after operation (n=35),&#xD;
      Communication before and after operation (n=36), and a control group who received no&#xD;
      communication on social media (n=36). Dental anxiety was evaluated one week before and after&#xD;
      the surgical operation using recognized assessment scales-the Spielberger's State-Trait&#xD;
      Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2018</start_date>
  <completion_date type="Actual">May 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 8, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Visual analog scale (VAS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The VAS scale was included in the present study to determine how anxious the patients felt according to their own thoughts. Scores range from 0 (no anxiety) to 10 (extreme anxiety).</description>
  </primary_outcome>
  <other_outcome>
    <measure>State-Trait Anxiety Inventory (STAI-T and STAI-S)</measure>
    <time_frame>2 weeks</time_frame>
    <description>STAI-S, like kinetic energy, refers to a palpable reaction or process taking place at a given time and level of intensity. STAI-T, like potential energy, refers to individual differences in reactions. Both of STAI-S and STAI-T scales includes 20 questions. For each question, the scores range from 1 (almost never) to 4 (almost always) points. For both scales, the sum of the scores ranges from 20 to 80. A score between 36 and 41 refers to a mean anxiety level, with values greater than 41 classified as a high level of anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Dental Anxiety Scale (MDAS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The MDAS consists of 5 questions that measure anxiety at different stages of dental treatment. The options range from 1 (not anxious) to 5 (very anxious) for each question. The sum of the scores varies from 5 to 25; values between 19 and 25 indicate a high level of dental anxiety.</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">143</enrollment>
  <condition>Dental Anxiety</condition>
  <condition>Timing in Dentist-Patient Communication</condition>
  <arm_group>
    <arm_group_label>Communication before operation</arm_group_label>
    <description>Communication was established before the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Communication after operation</arm_group_label>
    <description>Communication was established after the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Communication before and after operation</arm_group_label>
    <description>Communication took place both before and after the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No communication</arm_group_label>
    <description>No communication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assessment scales-the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.</intervention_name>
    <description>STAI-S, like kinetic energy, refers to a palpable reaction or process taking place at a given time and level of intensity. STAI-T, like potential energy, refers to individual differences in reactions. Both of STAI-S and STAI-T scales includes 20 questions. For each question, the scores range from 1 (almost never) to 4 (almost always) points. For both scales, the sum of the scores ranges from 20 to 80. A score between 36 and 41 refers to a mean anxiety level, with values greater than 41 classified as a high level of anxiety.&#xD;
The MDAS consists of 5 questions that measure anxiety at different stages of dental treatment. The options range from 1 (not anxious) to 5 (very anxious) for each question. The sum of the scores varies from 5 to 25; values between 19 and 25 indicate a high level of dental anxiety.&#xD;
The VAS scale was included in the present study to determine how anxious the patients felt according to their own thoughts. Scores range from 0 (no anxiety) to 10 (extreme anxiety).</description>
    <arm_group_label>Communication after operation</arm_group_label>
    <arm_group_label>Communication before and after operation</arm_group_label>
    <arm_group_label>Communication before operation</arm_group_label>
    <arm_group_label>No communication</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients scheduled to undergo impacted lower third molar removal at the oral and&#xD;
        maxillofacial surgery clinic at Karadeniz Teknik University were selected by randomly&#xD;
        between 2018 and 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be able to use the Instagram platform. I&#xD;
&#xD;
          -  Clinicial diagnosis of mesioangular impacted lower third molar according to the&#xD;
             classification of Winter and the Pell and Gregory classification (2 or 3/B).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who previously obtained information from social media&#xD;
&#xD;
          -  Bad dental history&#xD;
&#xD;
          -  Systemic disease&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Efe Can Sivrikaya</name>
      <address>
        <city>Trabzon</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Efe Sivrikaya</investigator_full_name>
    <investigator_title>Assistant Prof.</investigator_title>
  </responsible_party>
  <keyword>Communication</keyword>
  <keyword>Dental anxiety</keyword>
  <keyword>Social Media</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04453696/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04453696/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04453696
org study id: KaradenizTU01
nct id: NCT04453696
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Scales application one week before and one week after impacted tooth extraction.
The purpose of the present study was to assess the effects of dentist-patient communication
      via social media on dental anxiety, and second, to evaluate the appropriate timing of such
      communications.

      Instagram's quick replies system was used to answer patients' questions to alleviate dental
      anxiety for patients undergoing impacted mandibular third-molar extraction under local
      anesthesia. Patients were assigned randomly into four groups according to timing of such
      communications: Communication before operation (n=36), Communication after operation (n=35),
      Communication before and after operation (n=36), and a control group who received no
      communication on social media (n=36). Dental anxiety was evaluated one week before and after
      the surgical operation using recognized assessment scales-the Spielberger's State-Trait
      Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Visual analog scale (VAS)
time frame: 2 weeks
description: The VAS scale was included in the present study to determine how anxious the patients felt according to their own thoughts. Scores range from 0 (no anxiety) to 10 (extreme anxiety).
measure: State-Trait Anxiety Inventory (STAI-T and STAI-S)
time frame: 2 weeks
description: STAI-S, like kinetic energy, refers to a palpable reaction or process taking place at a given time and level of intensity. STAI-T, like potential energy, refers to individual differences in reactions. Both of STAI-S and STAI-T scales includes 20 questions. For each question, the scores range from 1 (almost never) to 4 (almost always) points. For both scales, the sum of the scores ranges from 20 to 80. A score between 36 and 41 refers to a mean anxiety level, with values greater than 41 classified as a high level of anxiety.
measure: Modified Dental Anxiety Scale (MDAS)
time frame: 2 weeks
description: The MDAS consists of 5 questions that measure anxiety at different stages of dental treatment. The options range from 1 (not anxious) to 5 (very anxious) for each question. The sum of the scores varies from 5 to 25; values between 19 and 25 indicate a high level of dental anxiety.
arm group label: Communication before operation
description: Communication was established before the operation.
arm group label: Communication after operation
description: Communication was established after the operation.
arm group label: Communication before and after operation
description: Communication took place both before and after the operation.
arm group label: No communication
description: No communication.
intervention type: Behavioral
intervention name: Assessment scales-the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.
description: STAI-S, like kinetic energy, refers to a palpable reaction or process taking place at a given time and level of intensity. STAI-T, like potential energy, refers to individual differences in reactions. Both of STAI-S and STAI-T scales includes 20 questions. For each question, the scores range from 1 (almost never) to 4 (almost always) points. For both scales, the sum of the scores ranges from 20 to 80. A score between 36 and 41 refers to a mean anxiety level, with values greater than 41 classified as a high level of anxiety.
The MDAS consists of 5 questions that measure anxiety at different stages of dental treatment. The options range from 1 (not anxious) to 5 (very anxious) for each question. The sum of the scores varies from 5 to 25; values between 19 and 25 indicate a high level of dental anxiety.
The VAS scale was included in the present study to determine how anxious the patients felt according to their own thoughts. Scores range from 0 (no anxiety) to 10 (extreme anxiety).
arm group label: Communication after operation
arm group label: Communication before and after operation
arm group label: Communication before operation
arm group label: No communication
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 36 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Efe Sivrikaya
investigator title: Assistant Prof.
mesh term: Anxiety Disorders
sharing ipd: Undecided
provided document: 
provided document: 