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/NCT05997368</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar67</org_study_id>
      <nct_id>NCT05997368</nct_id>
    </id_info>
    <brief_title>Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain</brief_title>
    <official_title>Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain</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>
        This study was planned to investigate the relationship between pain perceptions and pain&#xD;
        beliefs of individuals in different age groups with chronic low back pain and symptom&#xD;
        severity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted as an observational descriptive and cross-sectional research.&#xD;
        Participants will be recruited after the purpose and content of the research are explained by&#xD;
        the researchers, their written consent is read, and the volunteers who agree to be included&#xD;
        in the study are given their written consent. The data collection process was carried out&#xD;
        face-to-face and via a Google Forms survey over the internet, and will be conducted with the&#xD;
        participants face-to-face and online. In the study; The pain beliefs questionnaire (PBQ), the&#xD;
        centrality of pain scale (COPS) and the numerical rating scale (NRS-11) will be used.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The numeric rating scale - NRS-11</measure>
      <time_frame>2 weeks</time_frame>
      <description>When using the NRS-11, patients are asked to rate their pain on a scale of 0 to 10; where using integers (11 integers including zero) 0 represents &quot;no pain&quot; and 10 represents &quot;worst possible pain&quot;. Based on prior studies and clinical experience of use, pain screening scores NRS-11 scores as mild (1-3) are classified as moderate (4-6) or severe (7-10).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The centrality of pain scale - COPS)</measure>
      <time_frame>2 weeks</time_frame>
      <description>It is a short 10-item self-report scale designed to assess the centrality of pain. COPS scores are significantly correlated with the clinician's assessment of individual-reported pain severity, disability, mental health, quality of life, and how well the patient's pain is controlled. Each item is rated on a five-point Likert scale. It is a 10-item questionnaire (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4 and 9 are evaluated in reverse. The resulting value is the sum of all item scores. Higher scores indicate more &quot;central&quot; pain. The highest possible score is 50 and the lowest possible score is 10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The pain beliefs questionnaire - PBQ</measure>
      <time_frame>2 weeks</time_frame>
      <description>Two subtests of the test were created: the 8-item Organic Beliefs subtest and the 4-item Psychological Beliefs subtest. The item numbers of both subtests are listed as follows:&#xD;
  Organic Beliefs: items 1, 2, 3, 5, 7, 8, 10, 11, Psychological Beliefs: Items 4, 6, 9, 12. The test takers are asked to indicate the most appropriate one for the participants from 6 options ranging from 1st &quot;never&quot; to 6th &quot;always&quot;. The marked scores range from 1 to 6 for each item. The score collected for each subtest is calculated by taking the items in that subtest and summing them up and dividing the numbers by the number of items related to that subtest. An increase in the value calculated from the sub-dimension of the scale indicates that the belief in pain belonging to the sub-dimension is high, and a decrease in the value indicates low pain belief in the sub-dimension.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>young group</arm_group_label>
      <description>Participants aged 18-39</description>
    </arm_group>
    <arm_group>
      <arm_group_label>middle-aged group</arm_group_label>
      <description>Participants aged 40-56</description>
    </arm_group>
    <arm_group>
      <arm_group_label>elderly group</arm_group_label>
      <description>Participants aged 57-79</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey1</intervention_name>
      <description>As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing</description>
      <arm_group_label>young group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey2</intervention_name>
      <description>As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing</description>
      <arm_group_label>middle-aged group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Survey3</intervention_name>
      <description>As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing</description>
      <arm_group_label>elderly group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will take place in Istanbul, Turkey. Volunteers who accepted the voluntary&#xD;
          consent form will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  having low back pain for at least the past three months&#xD;
  &#xD;
            -  be between the ages of 18-79.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those outside the age limit of 18-79 and illiteracy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mahsun EKİNCİ</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>La Touche R, Grande-Alonso M, Arnes-Prieto P, Paris-Alemany A. How Does Self-Efficacy Influence Pain Perception, Postural Stability and Range of Motion in Individuals with Chronic Low Back Pain? Pain Physician. 2019 Jan;22(1):E1-E13.</citation>
      <PMID>30700075</PMID>
    </reference>
    <reference>
      <citation>Baird AJ, Haslam RA. Exploring differences in pain beliefs within and between a large nonclinical (workplace) population and a clinical (chronic low back pain) population using the pain beliefs questionnaire. Phys Ther. 2013 Dec;93(12):1615-24. doi: 10.2522/ptj.20120429. Epub 2013 Jul 25.</citation>
      <PMID>23886843</PMID>
    </reference>
    <reference>
      <citation>Pulvers K, Hood A. The role of positive traits and pain catastrophizing in pain perception. Curr Pain Headache Rep. 2013 May;17(5):330. doi: 10.1007/s11916-013-0330-2.</citation>
      <PMID>23512722</PMID>
    </reference>
    <reference>
      <citation>Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.</citation>
      <PMID>12031776</PMID>
    </reference>
    <reference>
      <citation>Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.</citation>
      <PMID>22225969</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 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>pain perception</keyword>
    <keyword>pain beliefs</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Chronic Pain</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/NCT05997368
  org study id: Uskudar67
  nct id: NCT05997368
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to investigate the relationship between pain perceptions and pain
        beliefs of individuals in different age groups with chronic low back pain and symptom
        severity.
  The study will be conducted as an observational descriptive and cross-sectional research.
        Participants will be recruited after the purpose and content of the research are explained by
        the researchers, their written consent is read, and the volunteers who agree to be included
        in the study are given their written consent. The data collection process was carried out
        face-to-face and via a Google Forms survey over the internet, and will be conducted with the
        participants face-to-face and online. In the study; The pain beliefs questionnaire (PBQ), the
        centrality of pain scale (COPS) and the numerical rating scale (NRS-11) will be used.
  observational model: Other
  time perspective: Prospective
  measure: The numeric rating scale - NRS-11
  time frame: 2 weeks
  description: When using the NRS-11, patients are asked to rate their pain on a scale of 0 to 10; where using integers (11 integers including zero) 0 represents "no pain" and 10 represents "worst possible pain". Based on prior studies and clinical experience of use, pain screening scores NRS-11 scores as mild (1-3) are classified as moderate (4-6) or severe (7-10).
  measure: The centrality of pain scale - COPS)
  time frame: 2 weeks
  description: It is a short 10-item self-report scale designed to assess the centrality of pain. COPS scores are significantly correlated with the clinician's assessment of individual-reported pain severity, disability, mental health, quality of life, and how well the patient's pain is controlled. Each item is rated on a five-point Likert scale. It is a 10-item questionnaire (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4 and 9 are evaluated in reverse. The resulting value is the sum of all item scores. Higher scores indicate more "central" pain. The highest possible score is 50 and the lowest possible score is 10.
  measure: The pain beliefs questionnaire - PBQ
  time frame: 2 weeks
  description: Two subtests of the test were created: the 8-item Organic Beliefs subtest and the 4-item Psychological Beliefs subtest. The item numbers of both subtests are listed as follows:
  Organic Beliefs: items 1, 2, 3, 5, 7, 8, 10, 11, Psychological Beliefs: Items 4, 6, 9, 12. The test takers are asked to indicate the most appropriate one for the participants from 6 options ranging from 1st "never" to 6th "always". The marked scores range from 1 to 6 for each item. The score collected for each subtest is calculated by taking the items in that subtest and summing them up and dividing the numbers by the number of items related to that subtest. An increase in the value calculated from the sub-dimension of the scale indicates that the belief in pain belonging to the sub-dimension is high, and a decrease in the value indicates low pain belief in the sub-dimension.
  arm group label: young group
  description: Participants aged 18-39
  arm group label: middle-aged group
  description: Participants aged 40-56
  arm group label: elderly group
  description: Participants aged 57-79
  intervention type: Other
  intervention name: Survey1
  description: As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
  arm group label: young group
  intervention type: Other
  intervention name: Survey2
  description: As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
  arm group label: middle-aged group
  intervention type: Other
  intervention name: Survey3
  description: As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
  arm group label: elderly group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: Mahsun EKİNCİ
  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: La Touche R, Grande-Alonso M, Arnes-Prieto P, Paris-Alemany A. How Does Self-Efficacy Influence Pain Perception, Postural Stability and Range of Motion in Individuals with Chronic Low Back Pain? Pain Physician. 2019 Jan;22(1):E1-E13.
  PMID: 30700075
  citation: Baird AJ, Haslam RA. Exploring differences in pain beliefs within and between a large nonclinical (workplace) population and a clinical (chronic low back pain) population using the pain beliefs questionnaire. Phys Ther. 2013 Dec;93(12):1615-24. doi: 10.2522/ptj.20120429. Epub 2013 Jul 25.
  PMID: 23886843
  citation: Pulvers K, Hood A. The role of positive traits and pain catastrophizing in pain perception. Curr Pain Headache Rep. 2013 May;17(5):330. doi: 10.1007/s11916-013-0330-2.
  PMID: 23512722
  citation: Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.
  PMID: 12031776
  citation: Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.
  PMID: 22225969
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Low Back Pain
  mesh term: Chronic Pain
  sharing ipd: No