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/NCT05998044</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar66</org_study_id>
      <nct_id>NCT05998044</nct_id>
    </id_info>
    <brief_title>Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial</brief_title>
    <official_title>Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual&#xD;
        symptom (PMS) symptoms, perceived stress level and pain intensity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research is a quantitative study, and it is in the form of randomized controlled type&#xD;
        research, one of the experimental research types. The sample of the study consisted of people&#xD;
        who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and&#xD;
        volunteered to participate in the study. Participants will be divided into 2 groups as&#xD;
        experimental group and control group by randomization method. Sociodemographic Information&#xD;
        Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack&#xD;
        Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data&#xD;
        were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <intervention_model_description>Pilates exercises will be given to the experimental group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Premenstrual Syndrome Scale (PMSS)</measure>
      <time_frame>10 weeks</time_frame>
      <description>PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the &quot;being in the period one week before the period&quot;. In scoring the scale, &quot;Never&quot; option is evaluated as 1 point, &quot;Very little&quot; option as 2 points, &quot;Sometimes&quot; option as 3 points, &quot;Often&quot; option as 4 points and &quot;Constantly&quot; option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale (PSS)</measure>
      <time_frame>10 weeks</time_frame>
      <description>The perceived stress scale consists of 14 five-point Likert type items. The scale consists of &quot;never (0), almost never&quot; (1), &quot;sometimes&quot; (2), &quot;often&quot; (3) &quot;very often&quot; (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>McGill Melzack Pain Questionnaire (MPQ)</measure>
      <time_frame>10 weeks</time_frame>
      <description>MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Premenstrual Syndrome</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Before starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>pilates group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pilates Based Exercises</intervention_name>
      <description>The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises.&#xD;
  Exercise Program:&#xD;
  Arm Circles&#xD;
  Toe Touch&#xD;
  bridge&#xD;
  Shoulder Bridge&#xD;
  Chest Lift&#xD;
  Hundred&#xD;
  Roll Up&#xD;
  Leg Circles&#xD;
  Chris Cross&#xD;
  Side Kick&#xD;
  Side Leg Circles&#xD;
  one leg kick&#xD;
  double leg kick&#xD;
  Swan&#xD;
  Single leg Stretch&#xD;
  Double leg Stretch&#xD;
  saw&#xD;
  Spine Stretch</description>
      <arm_group_label>pilates group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>They will be asked not to participate in any regular exercise for 8 weeks.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a woman between the ages of 18-35.&#xD;
  &#xD;
            -  Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary,&#xD;
               mental diseases, etc. that will prevent exercise).&#xD;
  &#xD;
            -  Not having given birth.&#xD;
  &#xD;
            -  Volunteer to participate in the study.&#xD;
  &#xD;
            -  Having a score above the mild level on the PMSS score.&#xD;
  &#xD;
            -  Normal menstrual cycle.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a condition that prevents you from exercising.&#xD;
  &#xD;
            -  Having a chronic disease.&#xD;
  &#xD;
            -  Being on any medication regularly.&#xD;
  &#xD;
            -  Being pregnant.&#xD;
  &#xD;
            -  Being in the menopausal period.&#xD;
  &#xD;
            -  Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection,&#xD;
               fibroid/uterine tumor etc.)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Premenstrual syndrome is a female-specific disorder.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Şeyma AYKUT</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
        <phone>+905069787535</phone>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.</citation>
      <PMID>12725453</PMID>
    </reference>
    <reference>
      <citation>Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.</citation>
      <PMID>33246104</PMID>
    </reference>
    <reference>
      <citation>El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.</citation>
      <PMID>25279689</PMID>
    </reference>
    <reference>
      <citation>Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.</citation>
      <PMID>23016028</PMID>
    </reference>
    <reference>
      <citation>Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.</citation>
      <PMID>22030232</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>stress</keyword>
    <keyword>Pilates Based Exercises</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT05998044
  org study id: Uskudar66
  nct id: NCT05998044
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual
        symptom (PMS) symptoms, perceived stress level and pain intensity.
  The research is a quantitative study, and it is in the form of randomized controlled type
        research, one of the experimental research types. The sample of the study consisted of people
        who scored above the mild level according to the Premenstrual Syndrome Scale (PMSS) score and
        volunteered to participate in the study. Participants will be divided into 2 groups as
        experimental group and control group by randomization method. Sociodemographic Information
        Form, Premenstrual Syndrome Scale (PMSS), Perceived Stress Scale (PSS) and Mcgill Melzack
        Pain Scale (MPQ) will be administered to the participants. Pre- and post-intervention data
        were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pilates exercises will be given to the experimental group
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Premenstrual Syndrome Scale (PMSS)
  time frame: 10 weeks
  description: PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the "being in the period one week before the period". In scoring the scale, "Never" option is evaluated as 1 point, "Very little" option as 2 points, "Sometimes" option as 3 points, "Often" option as 4 points and "Constantly" option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.
  measure: Perceived Stress Scale (PSS)
  time frame: 10 weeks
  description: The perceived stress scale consists of 14 five-point Likert type items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.
  measure: McGill Melzack Pain Questionnaire (MPQ)
  time frame: 10 weeks
  description: MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.
  arm group label: control group
  arm group type: Active Comparator
  description: Before starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied.
  arm group label: pilates group
  arm group type: Experimental
  description: After people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied.
  intervention type: Other
  intervention name: Pilates Based Exercises
  description: The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises.
  Exercise Program:
  Arm Circles
  Toe Touch
  bridge
  Shoulder Bridge
  Chest Lift
  Hundred
  Roll Up
  Leg Circles
  Chris Cross
  Side Kick
  Side Leg Circles
  one leg kick
  double leg kick
  Swan
  Single leg Stretch
  Double leg Stretch
  saw
  Spine Stretch
  arm group label: pilates group
  intervention type: Other
  intervention name: control
  description: They will be asked not to participate in any regular exercise for 8 weeks.
  arm group label: control group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Premenstrual syndrome is a female-specific disorder.
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Şeyma AYKUT
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.
  PMID: 12725453
  citation: Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.
  PMID: 33246104
  citation: El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.
  PMID: 25279689
  citation: Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.
  PMID: 23016028
  citation: Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
  PMID: 22030232
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Premenstrual Syndrome
  sharing ipd: No