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/NCT06040866</url>
    </required_header>
    <id_info>
      <org_study_id>KA-22038</org_study_id>
      <nct_id>NCT06040866</nct_id>
    </id_info>
    <brief_title>Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea</brief_title>
    <official_title>Comparison of the Effects of Pain Neuroscience Education and Biomedical Pain Education in Primary Dysmenorrhea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe University</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 aim of this study was to compare the effects of biomedical pain education and pain&#xD;
        neuroscience education, in addition to routine exercise training, on menstrual pain&#xD;
        parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory&#xD;
        function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of&#xD;
        life in healthy individuals with primary dysmenorrhea.The design of the study is parallel&#xD;
        group, randomized study. Individuals will be randomly assigned to one of the pain&#xD;
        neuroscience education or biomedical pain education research arms.&#xD;
  &#xD;
        In the literature, there is no study comparing the effects of pain neuroscience education and&#xD;
        biomedical pain education in primary dysmenorrhea, which is a problem that affects women's&#xD;
        lives significantly. It is important to reveal the effects of different pain trainings for&#xD;
        effective pain management in primary dysmenorrhea.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study was to compare the effects of biomedical pain education and pain&#xD;
        neuroscience education, in addition to routine exercise training, on menstrual pain&#xD;
        parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory&#xD;
        function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of&#xD;
        life in healthy individuals with primary dysmenorrhea. The design of the study is parallel&#xD;
        group, randomized study. The study sample consists of healthy individuals aged 18 years and&#xD;
        older with primary dysmenorrhea symptoms.&#xD;
  &#xD;
        Individuals will be randomly assigned to one of the two research arms. In addition to the&#xD;
        exercise training, which includes stretching and relaxation exercises routinely used in the&#xD;
        field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the first&#xD;
        research arm will be given pain neuroscience education once a week for 2 weeks.&#xD;
  &#xD;
        In the second research arm, in addition to the exercise training that includes stretching and&#xD;
        relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in&#xD;
        primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks.&#xD;
  &#xD;
        Participants will be evaluated in terms of descriptive measurements and outcome measures 3&#xD;
        times in total, before the applications, immediately after the end of the application period,&#xD;
        and 3 months after the end of the applications. The primary outcome measurement parameter of&#xD;
        the study was determined as the Visual Analog Scale (VAS) score, which is used to determine&#xD;
        the severity of menstrual pain. Secondary outcome measures are menstrual stress level to be&#xD;
        evaluated with the Menstrual Distress Questionnaire, somatosensory function status to be&#xD;
        evaluated with the Central Sensitization Inventory, pain catastrophizing state to be&#xD;
        evaluated with the Menstrual Pain Specific Pain Catastrophizing Scale, pain beliefs status to&#xD;
        be assessed with the Pain Beliefs Questionnaire, anxiety/depressive symptom level to be&#xD;
        evaluated with Depression Anxiety Stress Scales-21 (DASS-21), quality of life to be evaluated&#xD;
        with World Health Organization Quality of Life Scale-Short Form and perception of change to&#xD;
        be evaluated by 5-point likert scale.&#xD;
  &#xD;
        Sample size calculated by assuming a standard deviation of 1 with a minimum study power of&#xD;
        80% and predicting an equal distribution to the study arms; 19 individuals for the first&#xD;
        research arm and 19 individuals for the second research arm, a total of 38 individuals were&#xD;
        determined. The research will be terminated after all evaluations of all individuals&#xD;
        participating in the study are completed, when the targeted sample size and power are&#xD;
        reached.&#xD;
  &#xD;
        In the literature, there is no study comparing the effects of pain neuroscience education and&#xD;
        biomedical pain education in primary dysmenorrhea, which is a problem that affects women's&#xD;
        lives significantly. It is important to reveal the effects of different pain trainings for&#xD;
        effective pain management in primary dysmenorrhea.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 9, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of menstrual pain</measure>
      <time_frame>Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Menstrual stress level</measure>
      <time_frame>Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Menstrual Distress Questionnaire (MDQ): The scale consists of 47 menstrual symptoms and 8 sub-symptom groups. Complaints are scored from 0 to 4. 0=no symptoms, 1=little, 2=moderate, 3=severe, 4=very severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Somatosensory function status</measure>
      <time_frame>Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Central Sensitization Inventory (CSI): CSI consists of two parts. Part A contains 25 items that assess somatic and emotional health-related symptoms common in Central sensitization-related disorders.&#xD;
  Each item is graded on a 5-point scale from (0) &quot;never&quot; to (4) &quot;always&quot;, with a maximum total score of 100. Higher scores indicate a higher degree of symptomatology. Section B includes 7 diagnoses of central sensitization syndromes (tension headaches/migraine, fibromyalgia, irritable bowel syndrome, restless legs syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three additional diagnoses found to be associated with central sensitization ( depression, anxiety/panic attack, and neck injury); Participants were asked, together with the year of diagnosis, &quot;Has any of the following conditions been diagnosed by a doctor?&quot; contains the question.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Menstrual pain catastrophizing state</measure>
      <time_frame>Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Pain Catastrophizing Scale: It has 13 items and consists of 3 sub-dimensions (helplessness, magnification and rumination). Questions are scored between 0-4. Subscales are determined by summing the scores of each item, and the total score (between 0 and 52 points) is calculated with the sum of all items. A higher score means a greater degree of catastrophization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Menstrual pain beliefs status</measure>
      <time_frame>Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Pain Beliefs Questionnaire (PBQ): It contains 12 items related to pain beliefs. PBQ-O is an 8-item subscale, and PBQ-P is a 4-item subscale. Organic beliefs sub-dimension consists of items 1, 2, 3, 5, 7, 8, 10 and 11, and psychological beliefs sub-dimension consists of items 4, 6, 9 and 12. Participants mark the appropriate answer for themselves on a 6-point response scale ranging from &quot;always&quot; to &quot;never&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety/depressive symptom level</measure>
      <time_frame>Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>Depression Anxiety Stress Scales-21 (DASS-21): It is a valid measure for depression, anxiety, and stress in adults. Each of the three subscales contains 7 items; each is answered from zero (never) to three (always).&#xD;
  Higher scores indicate greater levels of depression, anxiety, and stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life level</measure>
      <time_frame>Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)</time_frame>
      <description>World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF): 442 / 5.000 Çeviri sonuçları The WHOQOl-BREF is a 26-item self-administered questionnaire and covers 4 dimensions of quality of life (6 items for psychological health, 7 items for physical health, 3 items for social relationships, and 8 items for environmental health). Except for 3 questions targeting pain and discomfort, need for medical treatment, and negative emotions, each question has response categories ranging from 1 to 5, and a high score indicates high quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perception of change</measure>
      <time_frame>Change in menstrual symptoms immediately after the end of 2 menstrual cycles (each cycle is 28± 7 days) and 3 months after the end of the interventions compared with baseline</time_frame>
      <description>5-point likert scale: Individuals' perception of subjective changes in menstrual pain and other menstrual symptoms with interventions will be evaluated. -2= much worse, -1= slightly worse, 0= no change, 1= slightly better, 2= much better. The changes in the menstrual symptoms of the individuals just after the end of the interventions and 3 months after the end of the interventions will be questioned when compared with the baseline.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">38</enrollment>
    <condition>Primary Dysmenorrhea</condition>
    <arm_group>
      <arm_group_label>Pain neuroscience education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the exercise training (stretching and relaxation exercises), which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks. Participants in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biomedical pain education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the biomedical pain education arm, in addition to the exercise training (stretching and relaxation exercises) that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks. Participants in the biomedical pain education arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise training</intervention_name>
      <description>Exercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week.</description>
      <arm_group_label>Biomedical pain education</arm_group_label>
      <arm_group_label>Pain neuroscience education</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pain neuroscience education</intervention_name>
      <description>Participants in the first research arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.</description>
      <arm_group_label>Pain neuroscience education</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biomedical pain education</intervention_name>
      <description>Participants in the second research arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.</description>
      <arm_group_label>Biomedical pain education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Not having any known disease (systemic, metabolic, etc.),&#xD;
  &#xD;
            -  Meeting the primary dysmenorrhea criteria specified in the Primary Dysmenorrhea&#xD;
               Consensus Guide (onset of menstrual pain 6-24 months after menarche, menstrual pain&#xD;
               lasting 8-72 hours, and the most severe menstrual pain felt on the 1st or 2nd day of&#xD;
               menstruation),&#xD;
  &#xD;
            -  Having a regular menstrual cycle (28± 7 days),&#xD;
  &#xD;
            -  In the last 6 months, menstrual pain intensity is ≥ 4 cm according to the visual&#xD;
               analog scale,&#xD;
  &#xD;
            -  Nulligravid,&#xD;
  &#xD;
            -  18 years and over,&#xD;
  &#xD;
            -  Volunteer healthy female individuals who consented to participate in the study,&#xD;
               willing to be randomized, will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pathological pelvic conditions including endometriosis, chronic pelvic inflammatory&#xD;
               disease, adenomyosis, polycystic ovary syndrome, endometrial fibroids/polyps or&#xD;
               sexually transmitted diseases,&#xD;
  &#xD;
            -  History of pelvic or abdominal surgery&#xD;
  &#xD;
            -  Using anti-depressants or anxiolytics because of their ability to modulate the&#xD;
               sensation of pain,&#xD;
  &#xD;
            -  Receiving alternative treatment,&#xD;
  &#xD;
            -  Individuals using an intrauterine contraceptive device or birth control pill will not&#xD;
               be included.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Serap Özgül, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Serap Özgül, Prof.</last_name>
      <phone>+905339390803</phone>
      <email>serapky@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Büşra Nur Erol</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Büşra Nur Erol, PhD student</last_name>
        <phone>+905444932720</phone>
        <email>icerbusra@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ceren Gürşen, Assoc. Prof.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sezcan Mümüşoğlu, Assoc. Prof.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.</citation>
      <PMID>28844356</PMID>
    </reference>
    <reference>
      <citation>Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.</citation>
      <PMID>5749738</PMID>
    </reference>
    <reference>
      <citation>Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.</citation>
      <PMID>21951710</PMID>
    </reference>
    <reference>
      <citation>Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.</citation>
      <PMID>7726811</PMID>
    </reference>
    <reference>
      <citation>Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.</citation>
      <PMID>1491853</PMID>
    </reference>
    <reference>
      <citation>The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.</citation>
      <PMID>9672396</PMID>
    </reference>
    <reference>
      <citation>Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.</citation>
      <PMID>2691207</PMID>
    </reference>
    <reference>
      <citation>Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.</citation>
      <PMID>25558568</PMID>
    </reference>
    <reference>
      <citation>Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.</citation>
      <PMID>35382371</PMID>
    </reference>
    <reference>
      <citation>Haldeman S. North American Spine Society: failure of the pathology model to predict back pain. Spine (Phila Pa 1976). 1990 Jul;15(7):718-24. No abstract available.</citation>
      <PMID>2145646</PMID>
    </reference>
    <reference>
      <citation>Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.</citation>
      <PMID>21632273</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>SERAP ÖZGÜL</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dysmenorrhea</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/NCT06040866
  org study id: KA-22038
  nct id: NCT06040866
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to compare the effects of biomedical pain education and pain
        neuroscience education, in addition to routine exercise training, on menstrual pain
        parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory
        function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of
        life in healthy individuals with primary dysmenorrhea.The design of the study is parallel
        group, randomized study. Individuals will be randomly assigned to one of the pain
        neuroscience education or biomedical pain education research arms.
  
        In the literature, there is no study comparing the effects of pain neuroscience education and
        biomedical pain education in primary dysmenorrhea, which is a problem that affects women's
        lives significantly. It is important to reveal the effects of different pain trainings for
        effective pain management in primary dysmenorrhea.
  The aim of this study was to compare the effects of biomedical pain education and pain
        neuroscience education, in addition to routine exercise training, on menstrual pain
        parameters (pain severity and duration, analgesic use), menstrual stress, somatosensory
        function, pain catastrophizing, pain beliefs, anxiety/depressive symptom level and quality of
        life in healthy individuals with primary dysmenorrhea. The design of the study is parallel
        group, randomized study. The study sample consists of healthy individuals aged 18 years and
        older with primary dysmenorrhea symptoms.
  
        Individuals will be randomly assigned to one of the two research arms. In addition to the
        exercise training, which includes stretching and relaxation exercises routinely used in the
        field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the first
        research arm will be given pain neuroscience education once a week for 2 weeks.
  
        In the second research arm, in addition to the exercise training that includes stretching and
        relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in
        primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks.
  
        Participants will be evaluated in terms of descriptive measurements and outcome measures 3
        times in total, before the applications, immediately after the end of the application period,
        and 3 months after the end of the applications. The primary outcome measurement parameter of
        the study was determined as the Visual Analog Scale (VAS) score, which is used to determine
        the severity of menstrual pain. Secondary outcome measures are menstrual stress level to be
        evaluated with the Menstrual Distress Questionnaire, somatosensory function status to be
        evaluated with the Central Sensitization Inventory, pain catastrophizing state to be
        evaluated with the Menstrual Pain Specific Pain Catastrophizing Scale, pain beliefs status to
        be assessed with the Pain Beliefs Questionnaire, anxiety/depressive symptom level to be
        evaluated with Depression Anxiety Stress Scales-21 (DASS-21), quality of life to be evaluated
        with World Health Organization Quality of Life Scale-Short Form and perception of change to
        be evaluated by 5-point likert scale.
  
        Sample size calculated by assuming a standard deviation of 1 with a minimum study power of
        80% and predicting an equal distribution to the study arms; 19 individuals for the first
        research arm and 19 individuals for the second research arm, a total of 38 individuals were
        determined. The research will be terminated after all evaluations of all individuals
        participating in the study are completed, when the targeted sample size and power are
        reached.
  
        In the literature, there is no study comparing the effects of pain neuroscience education and
        biomedical pain education in primary dysmenorrhea, which is a problem that affects women's
        lives significantly. It is important to reveal the effects of different pain trainings for
        effective pain management in primary dysmenorrhea.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Severity of menstrual pain
  time frame: Change in severity of menstrual pain from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Visual Analogue Scale (VAS): This scale is a 10cm horizontal line. 0= no pain/meaning no effect, 10= unbearable pain/ experiencing
  measure: Menstrual stress level
  time frame: Change in level of menstrual stress from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Menstrual Distress Questionnaire (MDQ): The scale consists of 47 menstrual symptoms and 8 sub-symptom groups. Complaints are scored from 0 to 4. 0=no symptoms, 1=little, 2=moderate, 3=severe, 4=very severe.
  measure: Somatosensory function status
  time frame: Change in status of somatosensory function from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Central Sensitization Inventory (CSI): CSI consists of two parts. Part A contains 25 items that assess somatic and emotional health-related symptoms common in Central sensitization-related disorders.
  Each item is graded on a 5-point scale from (0) "never" to (4) "always", with a maximum total score of 100. Higher scores indicate a higher degree of symptomatology. Section B includes 7 diagnoses of central sensitization syndromes (tension headaches/migraine, fibromyalgia, irritable bowel syndrome, restless legs syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three additional diagnoses found to be associated with central sensitization ( depression, anxiety/panic attack, and neck injury); Participants were asked, together with the year of diagnosis, "Has any of the following conditions been diagnosed by a doctor?" contains the question.
  measure: Menstrual pain catastrophizing state
  time frame: Change in state of menstrual pain catastrophizing from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Pain Catastrophizing Scale: It has 13 items and consists of 3 sub-dimensions (helplessness, magnification and rumination). Questions are scored between 0-4. Subscales are determined by summing the scores of each item, and the total score (between 0 and 52 points) is calculated with the sum of all items. A higher score means a greater degree of catastrophization.
  measure: Menstrual pain beliefs status
  time frame: Change in status of menstrual pain beliefs from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Pain Beliefs Questionnaire (PBQ): It contains 12 items related to pain beliefs. PBQ-O is an 8-item subscale, and PBQ-P is a 4-item subscale. Organic beliefs sub-dimension consists of items 1, 2, 3, 5, 7, 8, 10 and 11, and psychological beliefs sub-dimension consists of items 4, 6, 9 and 12. Participants mark the appropriate answer for themselves on a 6-point response scale ranging from "always" to "never".
  measure: Anxiety/depressive symptom level
  time frame: Change in level of anxiety/depressive symptom from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: Depression Anxiety Stress Scales-21 (DASS-21): It is a valid measure for depression, anxiety, and stress in adults. Each of the three subscales contains 7 items; each is answered from zero (never) to three (always).
  Higher scores indicate greater levels of depression, anxiety, and stress.
  measure: Quality of life level
  time frame: Change in level of quality of life from baseline up to end of 2 menstrual cycles (each cycle is 28± 7 days)
  description: World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF): 442 / 5.000 Çeviri sonuçları The WHOQOl-BREF is a 26-item self-administered questionnaire and covers 4 dimensions of quality of life (6 items for psychological health, 7 items for physical health, 3 items for social relationships, and 8 items for environmental health). Except for 3 questions targeting pain and discomfort, need for medical treatment, and negative emotions, each question has response categories ranging from 1 to 5, and a high score indicates high quality of life.
  measure: Perception of change
  time frame: Change in menstrual symptoms immediately after the end of 2 menstrual cycles (each cycle is 28± 7 days) and 3 months after the end of the interventions compared with baseline
  description: 5-point likert scale: Individuals' perception of subjective changes in menstrual pain and other menstrual symptoms with interventions will be evaluated. -2= much worse, -1= slightly worse, 0= no change, 1= slightly better, 2= much better. The changes in the menstrual symptoms of the individuals just after the end of the interventions and 3 months after the end of the interventions will be questioned when compared with the baseline.
  arm group label: Pain neuroscience education
  arm group type: Experimental
  description: In addition to the exercise training (stretching and relaxation exercises), which includes stretching and relaxation exercises routinely used in the field of physiotherapy and rehabilitation in primary dysmenorrhea, the patients in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks. Participants in the pain neuroscience education arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
  arm group label: Biomedical pain education
  arm group type: Active Comparator
  description: In the biomedical pain education arm, in addition to the exercise training (stretching and relaxation exercises) that includes stretching and relaxation exercises routinely applied in the field of physiotherapy and rehabilitation in primary dysmenorrhea, biomedical pain education will be given once a week for 2 weeks. Participants in the biomedical pain education arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
  intervention type: Other
  intervention name: Exercise training
  description: Exercise training will be applied in the non-menstrual period during 2 menstrual cycles as stretching and relaxation exercises. Stretching exercises will include general stretching and specific stretching exercises and will take approximately 20 minutes in total. After the stretching exercises, relaxation exercise will be performed with diaphragmatic breathing for 10 minutes. The exercises will be performed with music accompanied by a physiotherapist once a week, and it will be recommended to do the exercises as a home program for 2 sessions a week.
  arm group label: Biomedical pain education
  arm group label: Pain neuroscience education
  intervention type: Other
  intervention name: Pain neuroscience education
  description: Participants in the first research arm will be given pain neuroscience education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
  arm group label: Pain neuroscience education
  intervention type: Other
  intervention name: Biomedical pain education
  description: Participants in the second research arm will be given biomedical pain education once a week for 2 weeks after their first menstruation. The training will be repeated with a reminder session at the end of the 2nd menstruation.
  arm group label: Biomedical pain education
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Serap Özgül, Prof.
  role: Principal Investigator
  affiliation: Hacettepe University
  last name: Serap Özgül, Prof.
  phone: +905339390803
  email: serapky@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Turkey
  citation: Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
  PMID: 28844356
  citation: Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968 Nov-Dec;30(6):853-67. doi: 10.1097/00006842-196811000-00006. No abstract available.
  PMID: 5749738
  citation: Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
  PMID: 21951710
  citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
  PMID: 7726811
  citation: Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.
  PMID: 1491853
  citation: The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
  PMID: 9672396
  citation: Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
  PMID: 2691207
  citation: Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
  PMID: 25558568
  citation: Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
  PMID: 35382371
  citation: Haldeman S. North American Spine Society: failure of the pathology model to predict back pain. Spine (Phila Pa 1976). 1990 Jul;15(7):718-24. No abstract available.
  PMID: 2145646
  citation: Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.
  PMID: 21632273
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: SERAP ÖZGÜL
  investigator title: Prof.
  mesh term: Dysmenorrhea
  sharing ipd: No