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/NCT05995730</url>
    </required_header>
    <id_info>
      <org_study_id>16214662/050.01.04/130</org_study_id>
      <nct_id>NCT05995730</nct_id>
    </id_info>
    <brief_title>Effect of Lavender Inhalation on Dysmenorrhea</brief_title>
    <official_title>Effect of Lavender Inhalation on Primary Dysmenorrhea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</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>
        This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea&#xD;
        and its symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research is a randomized controlled trial and an experimental research design will be&#xD;
        used. The research will be carried out with two groups as experimental (lavender) and control&#xD;
        (placebo) groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dysmenorrhea Symptom Assessment Form</measure>
      <time_frame>to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.</time_frame>
      <description>Form consists of questions about dysmenorrhea symptoms in the participants.As the score obtained from the form increases, the severity of the symptoms increases.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numerical Pain Scale</measure>
      <time_frame>to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.</time_frame>
      <description>It will be applied to evaluate the level of dysmenorrhea pain. Participants will be asked to rate their pain level from 0 to 10. As the score increases, the level of pain increases</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Dysmenorrhea</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lavender inhalation will be administered to this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Olive oil will be administered to the placebo group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lavender oil inhalation</intervention_name>
      <description>Lavender inhalation will be administered to this group. Participants will be asked to drop three drops of lavender oil solution on a small piece of cotton on the 1st, 2nd, and 3rd days of their first menstrual bleeding after enrollment in the study, hold it 7-10 cm from their noses, and sniff for 5 minutes. Participants will be asked to apply this application immediately after the onset of dysmenorrhea pain on the first day of their menstruation and to continue regularly every 8 hours for the first three days of menstrual bleeding. Participants will be asked to apply this application in the same way in two consecutive menstrual cycles and the participants will be followed in this process.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Olive oil will be administered to the placebo group. The application will be similar to the experimental group.</description>
      <arm_group_label>Placebo group</arm_group_label>
      <other_name>Olive oil</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having primary dysmenorrhea (degrees II and III),&#xD;
  &#xD;
            -  Single,&#xD;
  &#xD;
            -  Who have never been pregnant before,&#xD;
  &#xD;
            -  Having a regular menstrual cycle&#xD;
  &#xD;
            -  Without any genital organ disorder (such as fibroids, fibroadenoma, endometriosis,&#xD;
               metrorrhagia, ovarian cyst, pelvic inflammatory disease, chronic pelvic pain, other&#xD;
               pelvic pathologies)&#xD;
  &#xD;
            -  Not using contraceptive method,&#xD;
  &#xD;
            -  Having a normal sense of smell&#xD;
  &#xD;
            -  People who can smell odors and are not allergic to odors will be included in the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Married,&#xD;
  &#xD;
            -  Having a disease that causes dysmenorrhea,&#xD;
  &#xD;
            -  Regularly using a pharmacological and non-pharmacological method to relieve&#xD;
  &#xD;
            -  Dysmenorrhea pain during the study,&#xD;
  &#xD;
            -  Having a previous or unconcluded pregnancy,&#xD;
  &#xD;
            -  Having a chronic disease (diabetes, endometriosis, uterine congenital anomalies,&#xD;
               epilepsy, etc.),&#xD;
  &#xD;
            -  Using drugs that affect the menstrual cycle or dysmenorrhea,&#xD;
  &#xD;
            -  Persons who fill in the data collection form incompletely or not at all will not be&#xD;
               included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gönül Kurt, Assist. Prof</last_name>
      <phone>90 (312) 304</phone>
      <phone_ext>3902</phone_ext>
      <email>gonul.kurt@sbu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gönül Kurt, Assist. Prof</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sakarya Training and Research Hospital</name>
        <address>
          <city>Sakarya</city>
          <zip>54000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gönül Kurt, Associate professor</last_name>
        <phone>90 (312) 304</phone>
        <phone_ext>3902</phone_ext>
        <email>gonul.kurt@sbu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dysmenorrhea</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995730
  org study id: 16214662/050.01.04/130
  nct id: NCT05995730
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea
        and its symptoms.
  The research is a randomized controlled trial and an experimental research design will be
        used. The research will be carried out with two groups as experimental (lavender) and control
        (placebo) groups.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Dysmenorrhea Symptom Assessment Form
  time frame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
  description: Form consists of questions about dysmenorrhea symptoms in the participants.As the score obtained from the form increases, the severity of the symptoms increases.
  measure: Numerical Pain Scale
  time frame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
  description: It will be applied to evaluate the level of dysmenorrhea pain. Participants will be asked to rate their pain level from 0 to 10. As the score increases, the level of pain increases
  arm group label: Experimental group
  arm group type: Experimental
  description: Lavender inhalation will be administered to this group.
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Olive oil will be administered to the placebo group.
  intervention type: Other
  intervention name: Lavender oil inhalation
  description: Lavender inhalation will be administered to this group. Participants will be asked to drop three drops of lavender oil solution on a small piece of cotton on the 1st, 2nd, and 3rd days of their first menstrual bleeding after enrollment in the study, hold it 7-10 cm from their noses, and sniff for 5 minutes. Participants will be asked to apply this application immediately after the onset of dysmenorrhea pain on the first day of their menstruation and to continue regularly every 8 hours for the first three days of menstrual bleeding. Participants will be asked to apply this application in the same way in two consecutive menstrual cycles and the participants will be followed in this process.
  arm group label: Experimental group
  intervention type: Other
  intervention name: Placebo
  description: Olive oil will be administered to the placebo group. The application will be similar to the experimental group.
  arm group label: Placebo group
  other name: Olive oil
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gönül Kurt, Assist. Prof
  phone: 90 (312) 304
  phone ext: 3902
  email: gonul.kurt@sbu.edu.tr
  last name: Gönül Kurt, Assist. Prof
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Dysmenorrhea