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/NCT06009341</url>
    </required_header>
    <id_info>
      <org_study_id>Artroplasti gevşeme</org_study_id>
      <nct_id>NCT06009341</nct_id>
    </id_info>
    <brief_title>Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients</brief_title>
    <official_title>The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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>
        In this study, the effectiveness of a comprehensive training program consisting of pain&#xD;
        management, relaxation, breathing, massage and falling components will be investigated in&#xD;
        patients with total knee arthroplasty. In this randomized controlled study, the trainings&#xD;
        will be offered face-to-face after the initial evaluation and within the scope of&#xD;
        telemedicine with prepared videos. The first evaluation will be performed on the first&#xD;
        postoperative day and the last evaluation will be performed 3 months postoperatively. The aim&#xD;
        of this study is to evaluate the effectiveness of a comprehensive education program&#xD;
        consisting of pain management, relaxation, respiration, massage and fall components in&#xD;
        patients with total knee arthroplasty.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 19, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knee Society Short Form (KSSF)</measure>
      <time_frame>Change from Baseline KSSF at 12 weeks</time_frame>
      <description>The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>Change from Baseline VAS at 12 weeks</time_frame>
      <description>On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia (TSK)</measure>
      <time_frame>Change from Baseline TSK at 12 weeks</time_frame>
      <description>The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L Quality of Life Scale</measure>
      <time_frame>Change from Baseline EQ-5D-3L at 12 weeks</time_frame>
      <description>The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning &quot;worst imaginable health&quot; and 100 meaning &quot;best imaginable health&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Catastrophising Scale (PCS)</measure>
      <time_frame>Change from Baseline PCS at 12 weeks</time_frame>
      <description>Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Activity Specific Balance Confidence Scale (ABC)</measure>
      <time_frame>Change from Baseline ABC at 12 weeks</time_frame>
      <description>This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear of Falling Avoidance Behavior Questionnaire (FFABQ)</measure>
      <time_frame>Change from Baseline FFABQ at 12 weeks</time_frame>
      <description>The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Knee Arthroplasty</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants aged 50 and over&#xD;
  &#xD;
            -  Participants indicated for unilateral or bilateral total knee arthoplasty&#xD;
  &#xD;
            -  Individuals to be followed after surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other surgeries&#xD;
  &#xD;
            -  Individuals with neurological and orthopedic diagnoses&#xD;
  &#xD;
            -  Individuals with cognitive, hearing, speech and psychiatric problems that prevent them&#xD;
               from communicating&#xD;
  &#xD;
            -  Illiterate individuals&#xD;
  &#xD;
            -  Presence of malignancy&#xD;
  &#xD;
            -  Not signing the consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatih Özden, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatih Özden, PhD</last_name>
      <phone>543 433 4593</phone>
      <phone_ext>+90</phone_ext>
      <email>fatihozden@mu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Muğla Sıtkı Koçman Training and Research Hospital</name>
        <address>
          <city>Muğla</city>
          <state>Menteşe</state>
          <zip>48000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmet İmerci, MD</last_name>
        <phone>506 893 5276</phone>
        <phone_ext>+90</phone_ext>
        <email>ahmetimerci@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Fatih Ozden</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <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/NCT06009341
  org study id: Artroplasti gevşeme
  nct id: NCT06009341
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the effectiveness of a comprehensive training program consisting of pain
        management, relaxation, breathing, massage and falling components will be investigated in
        patients with total knee arthroplasty. In this randomized controlled study, the trainings
        will be offered face-to-face after the initial evaluation and within the scope of
        telemedicine with prepared videos. The first evaluation will be performed on the first
        postoperative day and the last evaluation will be performed 3 months postoperatively. The aim
        of this study is to evaluate the effectiveness of a comprehensive education program
        consisting of pain management, relaxation, respiration, massage and fall components in
        patients with total knee arthroplasty.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Knee Society Short Form (KSSF)
  time frame: Change from Baseline KSSF at 12 weeks
  description: The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.
  measure: Visual Analog Scale (VAS)
  time frame: Change from Baseline VAS at 12 weeks
  description: On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
  measure: Tampa Scale for Kinesiophobia (TSK)
  time frame: Change from Baseline TSK at 12 weeks
  description: The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
  measure: EQ-5D-3L Quality of Life Scale
  time frame: Change from Baseline EQ-5D-3L at 12 weeks
  description: The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
  measure: Pain Catastrophising Scale (PCS)
  time frame: Change from Baseline PCS at 12 weeks
  description: Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
  measure: Activity Specific Balance Confidence Scale (ABC)
  time frame: Change from Baseline ABC at 12 weeks
  description: This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.
  measure: Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
  time frame: Change from Baseline FFABQ at 12 weeks
  description: The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.
  arm group label: Intervention Group
  arm group type: Experimental
  description: In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day.
  arm group label: Control Group
  arm group type: Active Comparator
  description: The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given.
  intervention type: Other
  intervention name: Rehabilitation
  description: The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.
  arm group label: Control Group
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fatih Özden, PhD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor
  sharing ipd: No