<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/NCT04426799</url>
  </required_header>
  <id_info>
    <org_study_id>2020/1</org_study_id>
    <nct_id>NCT04426799</nct_id>
  </id_info>
  <brief_title>Effectiveness of Lemon Essential Oil of Aromatherapy in Reducing Test Anxiety in Nursing Students</brief_title>
  <official_title>Lemon Essential Oil in Reducing Test Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk 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>
      This study examines the effectiveness of lemon essential oil in reducing test anxiety in&#xD;
      first-year nursing students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While studies on the role of aromatherapy in reducing test anxiety exist, those evaluating&#xD;
      the effects of lemon essential oil on test anxiety are extremely limited. In this study, the&#xD;
      effect of a different aromatherapy application on reducing test anxiety was tried to be&#xD;
      determined by using lemon essential oil. It is envisaged to provide an alternative&#xD;
      aromatherapy application to students and educators to reduce test anxiety through the results&#xD;
      obtained in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2020</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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 randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Personal Information Form</measure>
    <time_frame>30 minutes</time_frame>
    <description>The personal information form contained nine questions on age, gender, education level, profession, place of residence, socio-economic status and total GPA (Grade Point Average).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test Anxiety Scale (TAS)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Developed by Bozkurt (2019), the scale evaluates the degree of anxiety students feel before a test on a scale of 0 to 10. A score of 0 indicates no anxiety, while a score of 10 indicates severe anxiety 28</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State Test Anxiety Scale</measure>
    <time_frame>30 minutes</time_frame>
    <description>Developed by Şahin in 2019, this scale determines students' anxiety levels before a test. It is a 4-point Likert-type scale consisting of three sub-dimensions and 22 items. The cognitive dimension consists of nine items (3, 4, 7, 9, 14, 16, 18, 20, 22), wherein the lowest possible score is nine and the highest score is 36. The psychosocial dimension consists of five items (6, 10, 12, 13, 21), wherein the lowest possible score is 5 and the highest score is 20. The physiological dimension includes eight items (1, 2, 5, 8, 11, 15, 17, 19), wherein the lowest possible score is 8 and the highest score is 32. Possible scores on the scale ranged between 22 and 88</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Nursing Student</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>application is done</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lemon essential oil</intervention_name>
    <description>A randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No respiratory system diseases (Asthma, Flu etc.)&#xD;
&#xD;
          -  no allergy to any smell, no pregnancy status,&#xD;
&#xD;
          -  absence of epilepsy discomfort,&#xD;
&#xD;
          -  not having a condition that prevents smell, not using any medication that will affect&#xD;
             heart rate and blood pressure,&#xD;
&#xD;
        exclusion criteria&#xD;
&#xD;
          -  Any respiratory system disease (Asthma, Flu, etc.).&#xD;
&#xD;
          -  have a known allergic response to essential oil to be used,&#xD;
&#xD;
          -  Lack of smell, use of any medication affecting heart rate and blood pressure,&#xD;
&#xD;
          -  to use other complementary medicine practices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Züfünaz Özer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sabahattin Zaim University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sabahattin Zaim University</name>
      <address>
        <city>İstanbul</city>
        <state>Center</state>
        <zip>25240</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>gülcan bahcecioğlu</investigator_full_name>
    <investigator_title>ASSISTANT PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>Lemon Essential Oil</keyword>
  <keyword>Test Anxiety,</keyword>
  <keyword>Student</keyword>
  <keyword>Nurse</keyword>
  <patient_data>
    <sharing_ipd>No</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>January 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT04426799/Prot_SAP_000.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/NCT04426799
org study id: 2020/1
nct id: NCT04426799
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examines the effectiveness of lemon essential oil in reducing test anxiety in
      first-year nursing students.
While studies on the role of aromatherapy in reducing test anxiety exist, those evaluating
      the effects of lemon essential oil on test anxiety are extremely limited. In this study, the
      effect of a different aromatherapy application on reducing test anxiety was tried to be
      determined by using lemon essential oil. It is envisaged to provide an alternative
      aromatherapy application to students and educators to reduce test anxiety through the results
      obtained in the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: : A randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul.
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Personal Information Form
time frame: 30 minutes
description: The personal information form contained nine questions on age, gender, education level, profession, place of residence, socio-economic status and total GPA (Grade Point Average).
measure: Test Anxiety Scale (TAS)
time frame: 30 minutes
description: Developed by Bozkurt (2019), the scale evaluates the degree of anxiety students feel before a test on a scale of 0 to 10. A score of 0 indicates no anxiety, while a score of 10 indicates severe anxiety 28
measure: State Test Anxiety Scale
time frame: 30 minutes
description: Developed by Şahin in 2019, this scale determines students' anxiety levels before a test. It is a 4-point Likert-type scale consisting of three sub-dimensions and 22 items. The cognitive dimension consists of nine items (3, 4, 7, 9, 14, 16, 18, 20, 22), wherein the lowest possible score is nine and the highest score is 36. The psychosocial dimension consists of five items (6, 10, 12, 13, 21), wherein the lowest possible score is 5 and the highest score is 20. The physiological dimension includes eight items (1, 2, 5, 8, 11, 15, 17, 19), wherein the lowest possible score is 8 and the highest score is 32. Possible scores on the scale ranged between 22 and 88
arm group label: Control group
arm group type: No Intervention
description: no application
arm group label: Experimental group
arm group type: Experimental
description: application is done
intervention type: Other
intervention name: lemon essential oil
description: A randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul
arm group label: Experimental group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Züfünaz Özer
role: Principal Investigator
affiliation: Sabahattin Zaim University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: gülcan bahcecioğlu
investigator title: ASSISTANT PROFESSOR
sharing ipd: No
provided document: 