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/NCT06008964</url>
    </required_header>
    <id_info>
      <org_study_id>Aromatherapy Group</org_study_id>
      <nct_id>NCT06008964</nct_id>
    </id_info>
    <brief_title>The Effect of Aromatherapy Applied After Cesarean Section on Pain Intensity and Comfort Level</brief_title>
    <official_title>Determination of the Effect of Aromatherapy Using Lavender and Ylang Ylang Essential Oils on Pain Severity and Comfort Level After Cesarean Section: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KTO Karatay University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Şerife İrem DÖNER</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Merve YAZAR</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>JULE ERİÇ HORASANLI</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>KTO Karatay University</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>
        Today, many complementary therapies such as acupuncture, reflexology, homeopathy,&#xD;
        hypnotherapy, music and aromatherapy are tried in addition to medical methods to reduce pain&#xD;
        and anxiety. Aromatherapy is a therapy method in which essential oils are used to protect and&#xD;
        improve physical and psychological health. Oils can be applied directly to a single person or&#xD;
        indirectly to people in a room by inhalation . In direct application without steam, essential&#xD;
        oils can be applied by inhalation by dripping onto a cotton ball . It is stated that lavender&#xD;
        aromatherapy, one of the most commonly used aromatherapies, has analgesic, antiseptic,&#xD;
        sedative, antispasmodic and healing properties Ylang Ylang aromatherapy is stated analgesic,&#xD;
        anti-inflammatory, antimicrobial, antiemetic,anti-tarral, carminative, sedative, antiseptic,&#xD;
        spasmolytic properties. In the studies conducted, anxiety, labor pain, labor duration, and&#xD;
        psychological effects of aromatherapy were examined, but no study was found in which lavender&#xD;
        and chamomile essential oils were used and the effects of pain and comfort level were&#xD;
        examined. The aim of this study is to determine the effect of lavender and Ylang Ylang&#xD;
        essential oils in relieving pain and increasing comfort after cesarean section.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 17, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain related to cesarean section</measure>
      <time_frame>post operative 4-8-12 hours</time_frame>
      <description>It will be measured with Visual Analog Scale. Visual Analog Scale has a rating between 0-10. The higher the score, the greater the pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>comfort related to cesarean section</measure>
      <time_frame>post operative 4-8-12 hours</time_frame>
      <description>Comfort will be measured with the postpartum comfort scale. The higher the score, the higher the comfort level.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Cesarean Section Complications</condition>
    <arm_group>
      <arm_group_label>Ylang Ylang oil Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>GROUP 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lavender oil</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>GROUP 2</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ylang Ylang oil with inhalation</intervention_name>
      <description>Ylang Ylang OIL WILL BE INHALED</description>
      <arm_group_label>Ylang Ylang oil Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lavender oil with inhalation</intervention_name>
      <description>LAVENDER OIL WILL BE INHALED</description>
      <arm_group_label>Lavender oil</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-49 years old,&#xD;
  &#xD;
            -  women who have had a cesarean section&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  epilepsy,&#xD;
  &#xD;
            -  migraine,&#xD;
  &#xD;
            -  chronic headache,&#xD;
  &#xD;
            -  asthma,&#xD;
  &#xD;
            -  women who are allergic to fragrance sensitivities to aromatic oils&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women aged 18-49 who have undergone cesarean section</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>şerife irem döner</last_name>
      <role>Study Chair</role>
      <affiliation>serifeiremdoner@gmail.com</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Merve Yazar</last_name>
      <role>Study Chair</role>
      <affiliation>merve.yazar@karatay.edu.tr</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HAFİZE DAĞ TÜZMEN</last_name>
      <phone>05357446142</phone>
      <email>hafize.dag.tuzmen@karatay.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>KTO Karatay University</name>
        <address>
          <city>Konya</city>
          <zip>42000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Hafize DAĞ TÜZMEN</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>KTO Karatay University</investigator_affiliation>
      <investigator_full_name>Hafize Dağ Tüzmen</investigator_full_name>
      <investigator_title>LECTURER</investigator_title>
    </responsible_party>
    <keyword>Aromatherapy</keyword>
    <keyword>pain</keyword>
    <keyword>ceserean</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06008964
  org study id: Aromatherapy Group
  nct id: NCT06008964
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Today, many complementary therapies such as acupuncture, reflexology, homeopathy,
        hypnotherapy, music and aromatherapy are tried in addition to medical methods to reduce pain
        and anxiety. Aromatherapy is a therapy method in which essential oils are used to protect and
        improve physical and psychological health. Oils can be applied directly to a single person or
        indirectly to people in a room by inhalation . In direct application without steam, essential
        oils can be applied by inhalation by dripping onto a cotton ball . It is stated that lavender
        aromatherapy, one of the most commonly used aromatherapies, has analgesic, antiseptic,
        sedative, antispasmodic and healing properties Ylang Ylang aromatherapy is stated analgesic,
        anti-inflammatory, antimicrobial, antiemetic,anti-tarral, carminative, sedative, antiseptic,
        spasmolytic properties. In the studies conducted, anxiety, labor pain, labor duration, and
        psychological effects of aromatherapy were examined, but no study was found in which lavender
        and chamomile essential oils were used and the effects of pain and comfort level were
        examined. The aim of this study is to determine the effect of lavender and Ylang Ylang
        essential oils in relieving pain and increasing comfort after cesarean section.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: pain related to cesarean section
  time frame: post operative 4-8-12 hours
  description: It will be measured with Visual Analog Scale. Visual Analog Scale has a rating between 0-10. The higher the score, the greater the pain.
  measure: comfort related to cesarean section
  time frame: post operative 4-8-12 hours
  description: Comfort will be measured with the postpartum comfort scale. The higher the score, the higher the comfort level.
  arm group label: Ylang Ylang oil Group
  arm group type: Active Comparator
  description: GROUP 1
  arm group label: Control Group
  arm group type: No Intervention
  description: No intervention
  arm group label: Lavender oil
  arm group type: Active Comparator
  description: GROUP 2
  intervention type: Other
  intervention name: Ylang Ylang oil with inhalation
  description: Ylang Ylang OIL WILL BE INHALED
  arm group label: Ylang Ylang oil Group
  intervention type: Other
  intervention name: Lavender oil with inhalation
  description: LAVENDER OIL WILL BE INHALED
  arm group label: Lavender oil
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women aged 18-49 who have undergone cesarean section
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: şerife irem döner
  role: Study Chair
  affiliation: serifeiremdoner@gmail.com
  last name: Merve Yazar
  role: Study Chair
  affiliation: merve.yazar@karatay.edu.tr
  last name: HAFİZE DAĞ TÜZMEN
  phone: 05357446142
  email: hafize.dag.tuzmen@karatay.edu.tr
  facility: 
  status: Recruiting
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: KTO Karatay University
  investigator full name: Hafize Dağ Tüzmen
  investigator title: LECTURER
  sharing ipd: No