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/NCT06026540</url>
    </required_header>
    <id_info>
      <org_study_id>2023/01</org_study_id>
      <nct_id>NCT06026540</nct_id>
    </id_info>
    <brief_title>The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study</brief_title>
    <official_title>The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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>
        This project is to examine the effect of pilates exercise, which is applied by university&#xD;
        students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle&#xD;
        behaviors.&#xD;
  &#xD;
        Methods: The research to be carried out within the scope of the project is randomized&#xD;
        controlled and has an experimental research design. The population of the research consists&#xD;
        of 385 female students studying at the Department of Midwifery at Istanbul&#xD;
        University-Cerrahpaşa Faculty of Health Sciences. In the study, it is aimed to reach all&#xD;
        students without making a sample calculation in order to identify the students with PMS&#xD;
        symptoms among all students. Students who score 110 and above on the Premenstrual Syndrome&#xD;
        Scale (PMSS) will be considered to have PMS symptoms. The sample size of the students showing&#xD;
        PMS symptoms was determined by using the G*Power (3.1.9.2) program and considering the 0.05&#xD;
        margin of error and data loss, according to 95% power and medium effect size; 27 people&#xD;
        should be included in the experimental group and 27 people in the control group. In&#xD;
        determining the groups, the participants will be assigned to the experimental and control&#xD;
        groups using the &quot;Randomizer.org&quot; program. Students included in the research will be given&#xD;
        information about the study and will be presented with an &quot;Informed Consent Form&quot; and a&#xD;
        &quot;Volunteer Consent Form&quot;. While the experimental group will be given pilates exercises, under&#xD;
        the guidance of a peer, for half an hour twice a week for six months, the control group will&#xD;
        maintain their routine habits. At the beginning of the study, data will be collected with the&#xD;
        &quot;Personal Information Form&quot;, &quot;Premenstrual Syndrome Scale (PMSÖ)&quot; and &quot;Healthy Lifestyle&#xD;
        Behaviors Scale-II (SYBDS-II)&quot;. In the third and sixth months of the study, the hypotheses&#xD;
        will be tested by applying PMSS and HLBS-II. The data obtained in the research will be&#xD;
        entered into the database in the IBM SPSS 25.0 (Statistical Package for the Social Sciences)&#xD;
        program and all necessary statistical analyzes will be performed in the same program.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Premenstrual Syndrome Scale</measure>
      <time_frame>6 months</time_frame>
      <description>The lowest 44 and the highest 220 points can be obtained from the scale. The higher the score, the more severe the PMS problems are. If the person exceeds 50% of the total scale score (110 points in total) on the PMS scale, PMS is considered to be present.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Premenstrual Syndrome</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via &quot;Zoom&quot; includes the following order:&#xD;
  &quot;Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be applied to the control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pilates Exercise</intervention_name>
      <description>After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via &quot;Zoom&quot; includes the following order:&#xD;
  &quot;Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes&quot;.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being an undergraduate student studying in the midwifery department of Istanbul&#xD;
               University-Cerrahpaşa Faculty of Health Sciences,&#xD;
  &#xD;
            -  Having a score of 110 and above in PMSS,&#xD;
  &#xD;
            -  Having an internet connection,&#xD;
  &#xD;
            -  The Zoom program is installed and ready to use on its electronic device (phone or&#xD;
               computer),&#xD;
  &#xD;
            -  Having the environment to do Pilates.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being under the age of 18,&#xD;
  &#xD;
            -  Changes in menstruation characteristics after the diagnosis of PMS,&#xD;
  &#xD;
            -  Having a chronic or physical illness that prevents Pilates exercise.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Betül Uncu</name>
        <address>
          <city>Istanbul</city>
          <zip>34320</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Itriyeva K. Premenstrual syndrome and premenstrual dysphoric disorder in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101187. doi: 10.1016/j.cppeds.2022.101187. Epub 2022 May 6.</citation>
      <PMID>35534402</PMID>
    </reference>
    <reference>
      <citation>Pearce E, Jolly K, Jones LL, Matthewman G, Zanganeh M, Daley A. Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials. BJGP Open. 2020 Aug 25;4(3):bjgpopen20X101032. doi: 10.3399/bjgpopen20X101032. Print 2020 Aug.</citation>
      <PMID>32522750</PMID>
    </reference>
    <reference>
      <citation>Erbil N, Yucesoy H. Premenstrual syndrome prevalence in Turkey: a systematic review and meta-analysis. Psychol Health Med. 2023 Jun;28(5):1347-1357. doi: 10.1080/13548506.2021.2013509. Epub 2021 Dec 8.</citation>
      <PMID>34879766</PMID>
    </reference>
    <reference>
      <citation>Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.</citation>
      <PMID>33386201</PMID>
    </reference>
    <reference>
      <citation>Tsai SY, Kuo FC, Kuo HC, Liao LL. The prevalence of self-reported premenstrual symptoms and evaluation of regular exercise with premenstrual symptoms among female employees in Taiwan. Women Health. 2018 Mar;58(3):247-259. doi: 10.1080/03630242.2017.1296056. Epub 2017 Mar 20.</citation>
      <PMID>28318414</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Betul Uncu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>healthy living</keyword>
    <keyword>Peer guidance</keyword>
    <keyword>pilates exercise</keyword>
    <keyword>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/NCT06026540
  org study id: 2023/01
  nct id: NCT06026540
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This project is to examine the effect of pilates exercise, which is applied by university
        students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle
        behaviors.
  
        Methods: The research to be carried out within the scope of the project is randomized
        controlled and has an experimental research design. The population of the research consists
        of 385 female students studying at the Department of Midwifery at Istanbul
        University-Cerrahpaşa Faculty of Health Sciences. In the study, it is aimed to reach all
        students without making a sample calculation in order to identify the students with PMS
        symptoms among all students. Students who score 110 and above on the Premenstrual Syndrome
        Scale (PMSS) will be considered to have PMS symptoms. The sample size of the students showing
        PMS symptoms was determined by using the G*Power (3.1.9.2) program and considering the 0.05
        margin of error and data loss, according to 95% power and medium effect size; 27 people
        should be included in the experimental group and 27 people in the control group. In
        determining the groups, the participants will be assigned to the experimental and control
        groups using the "Randomizer.org" program. Students included in the research will be given
        information about the study and will be presented with an "Informed Consent Form" and a
        "Volunteer Consent Form". While the experimental group will be given pilates exercises, under
        the guidance of a peer, for half an hour twice a week for six months, the control group will
        maintain their routine habits. At the beginning of the study, data will be collected with the
        "Personal Information Form", "Premenstrual Syndrome Scale (PMSÖ)" and "Healthy Lifestyle
        Behaviors Scale-II (SYBDS-II)". In the third and sixth months of the study, the hypotheses
        will be tested by applying PMSS and HLBS-II. The data obtained in the research will be
        entered into the database in the IBM SPSS 25.0 (Statistical Package for the Social Sciences)
        program and all necessary statistical analyzes will be performed in the same program.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Premenstrual Syndrome Scale
  time frame: 6 months
  description: The lowest 44 and the highest 220 points can be obtained from the scale. The higher the score, the more severe the PMS problems are. If the person exceeds 50% of the total scale score (110 points in total) on the PMS scale, PMS is considered to be present.
  arm group label: experimental group
  arm group type: Experimental
  description: After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via "Zoom" includes the following order:
  "Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes".
  arm group label: Control group
  arm group type: No Intervention
  description: No intervention will be applied to the control group
  intervention type: Behavioral
  intervention name: Pilates Exercise
  description: After the first measurements were made and the groups were determined; Students in the experimental group will be given pilates exercises 2 days a week for 6 months. Pilates mat, pilates circle, tiny pilates ball and pilates band will be used during the pilates exercise. The duration of the Pilates exercise is 30 minutes in total, and the peer-guided application via "Zoom" includes the following order:
  "Stretching 5 minutes, superman 1 minute, quodratus stretch 2 minutes, marble 1 minute, half plank kick 4 minutes, side kick 4 minutes, pelvic curl 2 minutes, cat pose 1 minute, spine stretch 2 minutes, one leg circle 3 minutes, side leg lift 3 minutes, single leg kick 2 minutes".
  arm group label: experimental group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Itriyeva K. Premenstrual syndrome and premenstrual dysphoric disorder in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101187. doi: 10.1016/j.cppeds.2022.101187. Epub 2022 May 6.
  PMID: 35534402
  citation: Pearce E, Jolly K, Jones LL, Matthewman G, Zanganeh M, Daley A. Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials. BJGP Open. 2020 Aug 25;4(3):bjgpopen20X101032. doi: 10.3399/bjgpopen20X101032. Print 2020 Aug.
  PMID: 32522750
  citation: Erbil N, Yucesoy H. Premenstrual syndrome prevalence in Turkey: a systematic review and meta-analysis. Psychol Health Med. 2023 Jun;28(5):1347-1357. doi: 10.1080/13548506.2021.2013509. Epub 2021 Dec 8.
  PMID: 34879766
  citation: Batibay S, Kulcu DG, Kaleoglu O, Mesci N. Effect of Pilates mat exercise and home exercise programs on pain, functional level, and core muscle thickness in women with chronic low back pain. J Orthop Sci. 2021 Nov;26(6):979-985. doi: 10.1016/j.jos.2020.10.026. Epub 2020 Dec 29.
  PMID: 33386201
  citation: Tsai SY, Kuo FC, Kuo HC, Liao LL. The prevalence of self-reported premenstrual symptoms and evaluation of regular exercise with premenstrual symptoms among female employees in Taiwan. Women Health. 2018 Mar;58(3):247-259. doi: 10.1080/03630242.2017.1296056. Epub 2017 Mar 20.
  PMID: 28318414
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Betul Uncu
  investigator title: Principal Investigator
  mesh term: Syndrome
  mesh term: Premenstrual Syndrome
  sharing ipd: No