<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/NCT03784976</url>
  </required_header>
  <id_info>
    <org_study_id>18257</org_study_id>
    <nct_id>NCT03784976</nct_id>
  </id_info>
  <brief_title>Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis</brief_title>
  <official_title>Iyengar Yoga for Treatment of Endometriosis and Secondary Dysmenorrhea: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</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>
      The purpose of this clinical trial is to look at the effectiveness of prescribing yoga&#xD;
      classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual&#xD;
      disorders on patients' self reported pain and quality of life.&#xD;
&#xD;
      Patients will be recruited from primary care clinics around Illinois, including Carle&#xD;
      Hospital. This is a randomized trial in which patients will first be randomized into the&#xD;
      control or intervention group. Patients in the control group will undergo usual care and be&#xD;
      surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be&#xD;
      offered the 3 months of yoga therapy complimentary after completing the 9 month control.&#xD;
      Control patients who choose to participate in the yoga therapy will be asked to also complete&#xD;
      the surveys at the end of the 3 month yoga intervention. Patients in the intervention group&#xD;
      will first undergo 3 months of regular care and then 3 months of biweekly yoga classes.&#xD;
      Participants will complete surveys at baseline, 3 months (after of control care), 6 months&#xD;
      (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of&#xD;
      observation and optional yoga practice).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will contact the research team with the information on the flyer. Participants&#xD;
      will be asked to come to the Iyengar Yoga Center (407 W Springfield Ave, Urbana, IL 61801) to&#xD;
      receive more information. Participants will need to disclose their diagnosis to the research&#xD;
      staff. If they are not aware of what their diagnosis is, they will need to contact their&#xD;
      physician to get their official diagnosis. For example, a woman with dysmenorrhea may be&#xD;
      diagnosed with poly cystic ovarian disease or endometriosis or idiopathic dysmenorrhea, or&#xD;
      another reproductive disease; participants will need to know their specific diagnosis or find&#xD;
      out their specific diagnosis and report it to the research staff. Participants can do this by&#xD;
      calling their physicians. For participants that are unaware of their diagnosis, they may also&#xD;
      request a copy of their medical records. These records may be shared with the research staff&#xD;
      to help determine diagnosis. The research staff will not keep these medical records, but&#xD;
      return them to the participants. Participants can then either consent on the first visit or&#xD;
      choose to take time as much time as they need and return to the yoga center when they are&#xD;
      ready to sign the consent form. Participants will complete the first round of surveys at the&#xD;
      yoga center after they sign the consent form (20 minutes). Participants will receive an email&#xD;
      or phone call from the study team to inform them of their randomization results.&#xD;
&#xD;
      A blind third party statistician will complete the randomization for all participants at the&#xD;
      beginning of the study for all 90 participants and will email the study coordinator with the&#xD;
      randomization results. Randomization will be done through a free online software called&#xD;
      graphpad. (https://www.graphpad.com/quickcalcs/randomize1.cfm).&#xD;
&#xD;
      The study lasts 12 months for the intervention and 9 months for the control group with an&#xD;
      optional 3 month yoga therapy session offered at the end: Once consented, participants will&#xD;
      fill out baseline surveys, and then undergo 3 months of usual care (no intervention), the&#xD;
      same baseline surveys will be filled out again, then participants will get biweekly free yoga&#xD;
      therapy classes for 3 months, and surveys will again be completed at the end of the&#xD;
      intervention. Patients will then have a 6 month follow up and will fill out the surveys one&#xD;
      last time. Recruitment will occur on a rolling basis so patients may join the study at&#xD;
      anytime and not have to wait for a batched group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 3, 2018</start_date>
  <completion_date type="Anticipated">July 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2, 2021</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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NIH PROMIS Pain Interference Survey</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 4 question short form. The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH PROMIS Pain Intensity Survey</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH PROMIS Fatigue Survey</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 4 question short form. The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH PROMIS Physical Function Survey</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 4 question short form. Physical Function measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH PROMIS Global Health Scale</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 7 question short form. The PROMIS Global Health measures assess an individual's physical, mental, and social health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Reported Home Practice survey</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>This survey is a 10 question survey about participants home yoga practice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Menstrual Distress Questionnaire</measure>
    <time_frame>baseline, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical perimenstrual symptoms. It is used to help clinicians and researchers make systematic, empirical evaluations of a woman's symptoms, of treatments, and of etiological theories.&#xD;
The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Secondary Dysmenorrhea</condition>
  <condition>Dysmenorrhea</condition>
  <condition>Dysmenorrhea Secondary</condition>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Endometriosis</condition>
  <condition>Fibroid</condition>
  <condition>Menstrual Pain</condition>
  <condition>Menstrual Disorder</condition>
  <condition>Menstrual Discomfort</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), and 12 months (after 6 months of observation and optional yoga practice).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Iyengar Yoga Therapy</intervention_name>
    <description>2 weekly yoga class (1.25 hours each)</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Iyengar Yoga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria for the proposed study is any menstruating female with&#xD;
             dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria any one who has not reached menarche (age of menstruation) or&#xD;
             who has reached menopause (no longer menstruates). This age range of exclusion is&#xD;
             roughly defined as anyone younger than 12 and older than 65. Pregnant individuals are&#xD;
             not eligible to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Must menstruate or be of menstruating age</gender_description>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Iyengar Yoga Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gwen Derk, PhD</last_name>
      <phone>805-797-9496</phone>
      <email>gderk2@illinois.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Urbana-Champaign</investigator_affiliation>
    <investigator_full_name>Kashif Ahmad</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Dysmenorrhea</mesh_term>
    <mesh_term>Menstruation Disturbances</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03784976
org study id: 18257
nct id: NCT03784976
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical trial is to look at the effectiveness of prescribing yoga
      classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual
      disorders on patients' self reported pain and quality of life.

      Patients will be recruited from primary care clinics around Illinois, including Carle
      Hospital. This is a randomized trial in which patients will first be randomized into the
      control or intervention group. Patients in the control group will undergo usual care and be
      surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be
      offered the 3 months of yoga therapy complimentary after completing the 9 month control.
      Control patients who choose to participate in the yoga therapy will be asked to also complete
      the surveys at the end of the 3 month yoga intervention. Patients in the intervention group
      will first undergo 3 months of regular care and then 3 months of biweekly yoga classes.
      Participants will complete surveys at baseline, 3 months (after of control care), 6 months
      (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of
      observation and optional yoga practice).
Participants will contact the research team with the information on the flyer. Participants
      will be asked to come to the Iyengar Yoga Center (407 W Springfield Ave, Urbana, IL 61801) to
      receive more information. Participants will need to disclose their diagnosis to the research
      staff. If they are not aware of what their diagnosis is, they will need to contact their
      physician to get their official diagnosis. For example, a woman with dysmenorrhea may be
      diagnosed with poly cystic ovarian disease or endometriosis or idiopathic dysmenorrhea, or
      another reproductive disease; participants will need to know their specific diagnosis or find
      out their specific diagnosis and report it to the research staff. Participants can do this by
      calling their physicians. For participants that are unaware of their diagnosis, they may also
      request a copy of their medical records. These records may be shared with the research staff
      to help determine diagnosis. The research staff will not keep these medical records, but
      return them to the participants. Participants can then either consent on the first visit or
      choose to take time as much time as they need and return to the yoga center when they are
      ready to sign the consent form. Participants will complete the first round of surveys at the
      yoga center after they sign the consent form (20 minutes). Participants will receive an email
      or phone call from the study team to inform them of their randomization results.

      A blind third party statistician will complete the randomization for all participants at the
      beginning of the study for all 90 participants and will email the study coordinator with the
      randomization results. Randomization will be done through a free online software called
      graphpad. (https://www.graphpad.com/quickcalcs/randomize1.cfm).

      The study lasts 12 months for the intervention and 9 months for the control group with an
      optional 3 month yoga therapy session offered at the end: Once consented, participants will
      fill out baseline surveys, and then undergo 3 months of usual care (no intervention), the
      same baseline surveys will be filled out again, then participants will get biweekly free yoga
      therapy classes for 3 months, and surveys will again be completed at the end of the
      intervention. Patients will then have a 6 month follow up and will fill out the surveys one
      last time. Recruitment will occur on a rolling basis so patients may join the study at
      anytime and not have to wait for a batched group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: NIH PROMIS Pain Interference Survey
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 4 question short form. The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
measure: NIH PROMIS Pain Intensity Survey
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.
measure: NIH PROMIS Fatigue Survey
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 4 question short form. The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.
measure: NIH PROMIS Physical Function Survey
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 4 question short form. Physical Function measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.
measure: NIH PROMIS Global Health Scale
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 7 question short form. The PROMIS Global Health measures assess an individual's physical, mental, and social health.
measure: Self-Reported Home Practice survey
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: This survey is a 10 question survey about participants home yoga practice.
measure: Menstrual Distress Questionnaire
time frame: baseline, 3 months, 6 months, 9 months, 12 months
description: The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical perimenstrual symptoms. It is used to help clinicians and researchers make systematic, empirical evaluations of a woman's symptoms, of treatments, and of etiological theories.
The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms.
arm group label: Intervention
arm group type: Experimental
description: Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), and 12 months (after 6 months of observation and optional yoga practice).
arm group label: Control
arm group type: No Intervention
description: The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end
intervention type: Other
intervention name: Iyengar Yoga Therapy
description: 2 weekly yoga class (1.25 hours each)
arm group label: Intervention
other name: Iyengar Yoga
criteria: 
gender: Female
gender based: Yes
gender description: Must menstruate or be of menstruating age
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Urbana-Champaign
investigator full name: Kashif Ahmad
investigator title: Associate Professor
mesh term: Neoplasm Metastasis
mesh term: Polycystic Ovary Syndrome
mesh term: Endometriosis
mesh term: Dysmenorrhea
mesh term: Menstruation Disturbances
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)