<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/NCT03752255</url>
  </required_header>
  <id_info>
    <org_study_id>NEU2</org_study_id>
    <nct_id>NCT03752255</nct_id>
  </id_info>
  <brief_title>Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery</brief_title>
  <official_title>The Effects of Verbal and Visual Information Techniques on Anxiety in Impacted Third Molar Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konya Necmettin Erbakan Üniversitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Necmettin Erbakan Üniversitesi</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>
      The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale&#xD;
      (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will based on a prospective, observational investigation of two different patient&#xD;
      education techniques about the effect of third molar removal on patients' anxiety level. A&#xD;
      total of 240 patients will be divided into two groups.&#xD;
&#xD;
      Information about operation procedures and a recovery will be given verbally in group 1 and&#xD;
      information about operation procedures and recovery will be given in group 2. Anxiety levels&#xD;
      were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for&#xD;
      intra-group comparison of anxiety levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The anxiety levels will be examined using DAS and STAI.</measure>
    <time_frame>first day</time_frame>
    <description>first day</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Impacted Third Molar Tooth</condition>
  <arm_group>
    <arm_group_label>Anxiety measurement method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anxiety measurement method</intervention_name>
    <description>Two different techniques (video or verbal information) will be examined about impacted third molar surgery.</description>
    <arm_group_label>Anxiety measurement method</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Impacted third molar (bone and mucosa retention, mesioangular position)&#xD;
&#xD;
          -  Patients with any chronic disease and allergy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pericoronitis&#xD;
&#xD;
          -  Patients with visual impairment&#xD;
&#xD;
          -  Patients with psychological disorders&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek Menziletoglu, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necmettin Erbakan University</name>
      <address>
        <city>Konya</city>
        <state>Karatay</state>
        <zip>42050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konya Necmettin Erbakan Üniversitesi</investigator_affiliation>
    <investigator_full_name>Dilek Menziletoglu</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Video</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_browse>
  <!-- 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/NCT03752255
org study id: NEU2
nct id: NCT03752255
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate preoperative anxiety levels using dental anxiety scale
      (DAS) and the Spielberger State-Trait Anxiety Inventory (STAI).
This study will based on a prospective, observational investigation of two different patient
      education techniques about the effect of third molar removal on patients' anxiety level. A
      total of 240 patients will be divided into two groups.

      Information about operation procedures and a recovery will be given verbally in group 1 and
      information about operation procedures and recovery will be given in group 2. Anxiety levels
      were assessed by using DAS and (STAI).Paired t-test or Wilcoxon test will be used for
      intra-group comparison of anxiety levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: The anxiety levels will be examined using DAS and STAI.
time frame: first day
description: first day
arm group label: Anxiety measurement method
arm group type: Experimental
description: Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). Then patients will watch a video about impacted tooth. This video will include the complications that patients may face and what should be done after the procedure. After the watching the video, patients will fill the both DAS and STAI.
arm group label: Control
arm group type: Placebo Comparator
description: Before the operation, patients in the experimental group will fill the anxiety scales (DAS and STAI). The verbal information in detail will be given to the patients by the surgeon.This verbal information will include the complications that patients may face and what should be done after the procedure.
intervention type: Other
intervention name: Anxiety measurement method
description: Two different techniques (video or verbal information) will be examined about impacted third molar surgery.
arm group label: Anxiety measurement method
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dilek Menziletoglu, Dr
role: Principal Investigator
affiliation: Necmettin Erbakan University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Konya Necmettin Erbakan Üniversitesi
investigator full name: Dilek Menziletoglu
investigator title: Principle Investigator
mesh term: Tooth, Impacted