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/NCT05990361</url>
    </required_header>
    <id_info>
      <org_study_id>18.04.2023-90204</org_study_id>
      <nct_id>NCT05990361</nct_id>
    </id_info>
    <brief_title>Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women</brief_title>
    <official_title>Comparison of Sexual Function, Body Image, Kinesiophobia and Physical Activity Level in Women With and Without Pregnancy-related Pelvic Girdle Pain''</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muş Alparlan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muş Alparlan 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>
        This study compares sexual function, body image, kinesiophobia and physical activity level in&#xD;
        women with and without pregnancy-related pelvic girdle pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal&#xD;
        region and the sacroiliac joints, may spread to the back of the thigh, and may occur together&#xD;
        or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the&#xD;
        sexual life of women. Body image differs with the development of physical symptoms and&#xD;
        changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical&#xD;
        changes can cause problems in women's attitudes towards sexuality. Sexual function is&#xD;
        affected by physiological, anatomical and psychological changes that occur during pregnancy.&#xD;
        Sexual function during pregnancy has been associated with conditions such as body image,&#xD;
        physical activity level, and pain.&#xD;
  &#xD;
        In the literature, there are studies evaluating the relationship between sexual function and&#xD;
        body image in pregnant women and in different populations. However, in these studies,&#xD;
        questionnaires specific to pregnant women were not used to evaluate sexual function and body&#xD;
        image, and a comparison of these parameters was not investigate in women with and without&#xD;
        pregnancy-related PGP.&#xD;
  &#xD;
        Therefore, this study was planned to compare sexual function, body image, kinesiophobia and&#xD;
        physical activity levels in women with and without pregnancy-related PGP.&#xD;
  &#xD;
        The outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy&#xD;
        Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity&#xD;
        questionnaire (PPAQ).&#xD;
  &#xD;
        The clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation&#xD;
        Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction,&#xD;
        Patrick-Faber Test and Gaenslen Test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 24, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pregnancy Sexual Response Inventory-Turkish version</measure>
      <time_frame>immediately before the clinical diagnostic tests will be applied the questionnaire</time_frame>
      <description>to assess sexual functions in pregnant women with and without PGP</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Image in Pregnancy Scale (BIPS-Turkish)</measure>
      <time_frame>immediately before the clinical diagnostic tests will be applied the questionnaire</time_frame>
      <description>to evaluate body image perceptions of Turkish pregnant women with and without PGP</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia-Turkish version</measure>
      <time_frame>immediately before the clinical diagnostic tests will be applied the questionnaire</time_frame>
      <description>to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pregnancy Physical Activity Questionnaire-Turkish version</measure>
      <time_frame>immediately before the clinical diagnostic tests will be applied the questionnaire</time_frame>
      <description>To evaluate the physical activity level of pregnant women with and without PGP</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version</measure>
      <time_frame>immediately after the clinical diagnostic tests for PGP will be applied the questionnaire</time_frame>
      <description>To evaluate both disability and symptoms women with pregnancy-related PGP</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">118</enrollment>
    <condition>Pregnancy-Related Pelvic Girdle Pain</condition>
    <arm_group>
      <arm_group_label>women with pelvic girdle pain</arm_group_label>
      <description>The subjects who have at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as with PGP group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>women without pelvic girdle pain</arm_group_label>
      <description>The subjects who have not at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as without PGP group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>clinical diagnostic test</intervention_name>
      <description>The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT).&#xD;
  The subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group.</description>
      <arm_group_label>women with pelvic girdle pain</arm_group_label>
      <arm_group_label>women without pelvic girdle pain</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women with and without pregnancy-related pelvic girdle pain&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between 18 and 40 years-old,&#xD;
  &#xD;
            -  Being second or third trimester of pregnancy&#xD;
  &#xD;
            -  Being literate in Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a pregnancy complication (preeclampsia, pregnancy-induced hypertension,&#xD;
               diabetes, etc.),&#xD;
  &#xD;
            -  Having a known gynecological or urological problem that may mimic PGP&#xD;
  &#xD;
            -  Having neurological (multiple sclerosis, spinal cord injury, etc.), orthopedic (hip&#xD;
               dislocation, etc.), cardiopulmonary (heart failure, chronic obstructive pulmonary&#xD;
               disease, etc.) problems that affect sexual function and physical activity,&#xD;
  &#xD;
            -  Having situations in which sexual activity is contraindicated and should be restricted&#xD;
               (placenta previa, risk of premature birth, cervical insufficiency, antepartum&#xD;
               hemorrhage, premature rupture of membranes, genital infection, etc.),&#xD;
  &#xD;
            -  Having visual, auditory and cognitive problems that may prevent participation in the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SEMİHA YENİŞEHİR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muş Alparslan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>SEMİHA YENİŞEHİR, PT,PhD</last_name>
      <phone>+90 2494949</phone>
      <email>ysehir.semiha8@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>İLKİM ÇITAK KARAKAYA, PT.PhD.Prof.</last_name>
      <email>ilkim74@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Semiha Yenişehir</name>
        <address>
          <city>Muş</city>
          <zip>49000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SEMİHA YENİŞEHİR, PT,PhD</last_name>
        <phone>+90 2494949</phone>
        <email>ysehir.semiha8@gmail.com</email>
      </contact>
      <investigator>
        <last_name>SEMİHA YENİŞEHİR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pelvic girdle pain</keyword>
    <keyword>sexual function</keyword>
    <keyword>body image</keyword>
    <keyword>fear of movement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pelvic Girdle Pain</mesh_term>
      <mesh_term>Kinesiophobia</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/NCT05990361
  org study id: 18.04.2023-90204
  nct id: NCT05990361
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study compares sexual function, body image, kinesiophobia and physical activity level in
        women with and without pregnancy-related pelvic girdle pain.
  Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal
        region and the sacroiliac joints, may spread to the back of the thigh, and may occur together
        or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the
        sexual life of women. Body image differs with the development of physical symptoms and
        changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical
        changes can cause problems in women's attitudes towards sexuality. Sexual function is
        affected by physiological, anatomical and psychological changes that occur during pregnancy.
        Sexual function during pregnancy has been associated with conditions such as body image,
        physical activity level, and pain.
  
        In the literature, there are studies evaluating the relationship between sexual function and
        body image in pregnant women and in different populations. However, in these studies,
        questionnaires specific to pregnant women were not used to evaluate sexual function and body
        image, and a comparison of these parameters was not investigate in women with and without
        pregnancy-related PGP.
  
        Therefore, this study was planned to compare sexual function, body image, kinesiophobia and
        physical activity levels in women with and without pregnancy-related PGP.
  
        The outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy
        Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity
        questionnaire (PPAQ).
  
        The clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation
        Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction,
        Patrick-Faber Test and Gaenslen Test.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Pregnancy Sexual Response Inventory-Turkish version
  time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
  description: to assess sexual functions in pregnant women with and without PGP
  measure: Body Image in Pregnancy Scale (BIPS-Turkish)
  time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
  description: to evaluate body image perceptions of Turkish pregnant women with and without PGP
  measure: Tampa Scale for Kinesiophobia-Turkish version
  time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
  description: to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP
  measure: Pregnancy Physical Activity Questionnaire-Turkish version
  time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
  description: To evaluate the physical activity level of pregnant women with and without PGP
  measure: Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version
  time frame: immediately after the clinical diagnostic tests for PGP will be applied the questionnaire
  description: To evaluate both disability and symptoms women with pregnancy-related PGP
  arm group label: women with pelvic girdle pain
  description: The subjects who have at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as with PGP group.
  arm group label: women without pelvic girdle pain
  description: The subjects who have not at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as without PGP group.
  intervention type: Diagnostic Test
  intervention name: clinical diagnostic test
  description: The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT).
  The subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group.
  arm group label: women with pelvic girdle pain
  arm group label: women without pelvic girdle pain
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: SEMİHA YENİŞEHİR
  role: Principal Investigator
  affiliation: Muş Alparslan University
  last name: SEMİHA YENİŞEHİR, PT,PhD
  phone: +90 2494949
  email: ysehir.semiha8@gmail.com
  last name: İLKİM ÇITAK KARAKAYA, PT.PhD.Prof.
  email: ilkim74@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Pelvic Girdle Pain
  mesh term: Kinesiophobia
  sharing ipd: No