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/NCT06000579</url>
    </required_header>
    <id_info>
      <org_study_id>MrvHfz</org_study_id>
      <nct_id>NCT06000579</nct_id>
    </id_info>
    <brief_title>EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME</brief_title>
    <official_title>EFFECT OF EMOTIONAL FREEDOM TECHNIQUE ON PREMENSTRUAL SYNDROME: A RANDOMIZED CONTROLLED STUDY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KTO Karatay University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>EMEL EGE</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>KAMİLE ALTUNTUĞ</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Merve YAZAR</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>
        PMS is one of the common menstrual disorders affecting many young women, and according to&#xD;
        epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS&#xD;
        symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72%&#xD;
        in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and&#xD;
        14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration,&#xD;
        depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea,&#xD;
        vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep&#xD;
        disturbance, appetite changes. In addition to physical symptoms, studies indicate that&#xD;
        individuals reporting PMS experience more stress and anxiety, and their sensitivity to&#xD;
        depressive symptoms increases due to hormonal fluctuations. Studies have shown that&#xD;
        mindfulness-based cognitive methods are effective in the treatment of mood disorders such as&#xD;
        depression. It is thought that modulating many PMS symptoms such as stress and experienced&#xD;
        emotional problems through mindfulness-based cognitive methods may be an effective approach&#xD;
        for future PMS interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Actual">September 11, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>premenstrual syndrome and emotional freedom technique</measure>
      <time_frame>3 month Wıll Be Followed.</time_frame>
      <description>This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">42</enrollment>
    <condition>Premenstrual Syndrome</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EFT will be applied to individuals with premenstrual syndrome.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Individuals in the control group will not be interfered with.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EFT</intervention_name>
      <description>Each student will be asked to voluntarily give their phone number and last menstrual cycle date, and the day will be determined for the first session. Then, the first EFT session will be made by the researchers by calling 14 days before the menstruation date. In the 2nd and 3rd sessions, a total of 3 sessions of EFT will be applied face-to-face by the researchers 14 days before menstruation. After each student completes three menstrual cycles, the researchers will meet with the student and PMSS will be applied as a post-test.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Persons with amenorrhea,&#xD;
  &#xD;
            -  pregnancy,&#xD;
  &#xD;
            -  menstrual irregularity,&#xD;
  &#xD;
            -  chronic disease,&#xD;
  &#xD;
            -  mental disorders,&#xD;
  &#xD;
            -  psychiatric disorders,&#xD;
  &#xD;
            -  polycystic ovarian syndrome,&#xD;
  &#xD;
            -  those who have received training on EFT before and those who have communication&#xD;
               problems will not be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Female students between the ages of 18-25,&#xD;
  &#xD;
            -  who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)&#xD;
  &#xD;
            -  participated in the study voluntarily will be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Premenstrual syndrome is seen in women.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>MERVE YAZAR</last_name>
      <role>Study Chair</role>
      <affiliation>merve.yazar@karatay.edu.tr</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>KTO Karatay University</name>
        <address>
          <city>Konya</city>
          <zip>42000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Emotional Regulation, Premenstrual Syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Premenstrual Syndrome</mesh_term>
    </condition_browse>
    <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/NCT06000579
  org study id: MrvHfz
  nct id: NCT06000579
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  PMS is one of the common menstrual disorders affecting many young women, and according to
        epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS
        symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72%
        in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and
        14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration,
        depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea,
        vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep
        disturbance, appetite changes. In addition to physical symptoms, studies indicate that
        individuals reporting PMS experience more stress and anxiety, and their sensitivity to
        depressive symptoms increases due to hormonal fluctuations. Studies have shown that
        mindfulness-based cognitive methods are effective in the treatment of mood disorders such as
        depression. It is thought that modulating many PMS symptoms such as stress and experienced
        emotional problems through mindfulness-based cognitive methods may be an effective approach
        for future PMS interventions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: premenstrual syndrome and emotional freedom technique
  time frame: 3 month Wıll Be Followed.
  description: This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.
  arm group label: Experimental Group
  arm group type: Experimental
  description: EFT will be applied to individuals with premenstrual syndrome.
  arm group label: Control Group
  arm group type: No Intervention
  description: Individuals in the control group will not be interfered with.
  intervention type: Other
  intervention name: EFT
  description: Each student will be asked to voluntarily give their phone number and last menstrual cycle date, and the day will be determined for the first session. Then, the first EFT session will be made by the researchers by calling 14 days before the menstruation date. In the 2nd and 3rd sessions, a total of 3 sessions of EFT will be applied face-to-face by the researchers 14 days before menstruation. After each student completes three menstrual cycles, the researchers will meet with the student and PMSS will be applied as a post-test.
  arm group label: Experimental Group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Premenstrual syndrome is seen in women.
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MERVE YAZAR
  role: Study Chair
  affiliation: merve.yazar@karatay.edu.tr
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: KTO Karatay University
  investigator full name: Hafize Dağ Tüzmen
  investigator title: LECTURER
  mesh term: Syndrome
  mesh term: Premenstrual Syndrome
  sharing ipd: No