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/NCT05967676</url>
    </required_header>
    <id_info>
      <org_study_id>16.12.2022</org_study_id>
      <nct_id>NCT05967676</nct_id>
    </id_info>
    <brief_title>Psychological Readiness of Injured Athlete to Return to Sport</brief_title>
    <acronym>PRIA-RS</acronym>
    <official_title>Turkish Adaptation, Validity and Reliability of the Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS) Questionnaire</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nigde Omer Halisdemir University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Nigde Omer Halisdemir 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>
        Clinicians are recommended to assess athletes during the rehabilitation phase to identify&#xD;
        athletes with potentially maladaptive psychological responses to injury. Therefore, the&#xD;
        Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS) questionnaire was&#xD;
        developed to assess the athlete's psychological readiness to return to sport. The aim of this&#xD;
        study was to adapt the PRIA-RS questionnaire into Turkish and to establish its validity and&#xD;
        reliability. Serial approach method will be used while translating the questionnaire into&#xD;
        Turkish. In order to evaluate the validity of PRIA-RS, The Re-injury Anxiety Inventory and&#xD;
        Tampa Kinesiophobia Scale will be applied to the participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Adaptation, validity and reliability</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS)</measure>
      <time_frame>Baseline</time_frame>
      <description>The PRIA-RS questionnaire provides a comprehensive screening of psychological readiness for return to sport based on athlete-reported confidence, self-perception, insecurity and fear of re-injury at the end of competition. The PRIA-RS questionnaire consists of 10 questions with each question scored on a 5-point Likert scale (50 points total), with a higher score representing a more positive psychological response.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Re-injury Anxiety Inventory (RAI):</measure>
      <time_frame>Baseline</time_frame>
      <description>The questionnaire developed by Walker et al. to measure re-injury anxiety is a 4-point Likert-type questionnaire and consists of 28 items in total. The questionnaire consists of two subgroups including re-injury anxiety/concern about rehabilitation and re-injury anxiety/concern about return to sport and training. A higher score represents more re-injury anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa kinesiophobia scale (TKS)</measure>
      <time_frame>Baseline</time_frame>
      <description>It is a 17-question scale developed to measure fear of movement/reinjury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. The scale uses a 4-point Likert scale (Strongly disagree=1, Strongly agree=4). A higher score represents more kinesiophobia.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Athletic Injuries</condition>
    <arm_group>
      <arm_group_label>Patient group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>athletes who have suffered a sports injury</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Turkish adaptation, validity and reliability</intervention_name>
      <description>This study was conducted as &quot;test-retest&quot; design and the psychometric properties of PRIA-RS were examined in injured athletes</description>
      <arm_group_label>Patient group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  athletes who have missed at least 2 months of training due to injury&#xD;
  &#xD;
            -  having an upper, lower extremity or spine injury&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having a psychological disorder&#xD;
  &#xD;
            -  regular use of psychiatric medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>GÜRKAN DEMİRTAŞ, Msc.</last_name>
      <phone>+90 388 311 2105</phone>
      <email>gdemirtas255@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <state>Çankaya</state>
          <zip>06490</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>GÜRKAN DEMİRTAŞ, Msc</last_name>
        <phone>+90 388 311 2105</phone>
        <email>gdemirtas255@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nigde Omer Halisdemir University</investigator_affiliation>
      <investigator_full_name>Gürkan Demirtas</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Validity</keyword>
    <keyword>Reliability</keyword>
    <keyword>Turkish Adaptation</keyword>
    <keyword>Psychological Readiness</keyword>
    <keyword>sports injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Athletic Injuries</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/NCT05967676
  org study id: 16.12.2022
  nct id: NCT05967676
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clinicians are recommended to assess athletes during the rehabilitation phase to identify
        athletes with potentially maladaptive psychological responses to injury. Therefore, the
        Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS) questionnaire was
        developed to assess the athlete's psychological readiness to return to sport. The aim of this
        study was to adapt the PRIA-RS questionnaire into Turkish and to establish its validity and
        reliability. Serial approach method will be used while translating the questionnaire into
        Turkish. In order to evaluate the validity of PRIA-RS, The Re-injury Anxiety Inventory and
        Tampa Kinesiophobia Scale will be applied to the participants.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Adaptation, validity and reliability
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS)
  time frame: Baseline
  description: The PRIA-RS questionnaire provides a comprehensive screening of psychological readiness for return to sport based on athlete-reported confidence, self-perception, insecurity and fear of re-injury at the end of competition. The PRIA-RS questionnaire consists of 10 questions with each question scored on a 5-point Likert scale (50 points total), with a higher score representing a more positive psychological response.
  measure: Re-injury Anxiety Inventory (RAI):
  time frame: Baseline
  description: The questionnaire developed by Walker et al. to measure re-injury anxiety is a 4-point Likert-type questionnaire and consists of 28 items in total. The questionnaire consists of two subgroups including re-injury anxiety/concern about rehabilitation and re-injury anxiety/concern about return to sport and training. A higher score represents more re-injury anxiety.
  measure: Tampa kinesiophobia scale (TKS)
  time frame: Baseline
  description: It is a 17-question scale developed to measure fear of movement/reinjury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. The scale uses a 4-point Likert scale (Strongly disagree=1, Strongly agree=4). A higher score represents more kinesiophobia.
  arm group label: Patient group
  arm group type: Experimental
  description: athletes who have suffered a sports injury
  intervention type: Diagnostic Test
  intervention name: Turkish adaptation, validity and reliability
  description: This study was conducted as "test-retest" design and the psychometric properties of PRIA-RS were examined in injured athletes
  arm group label: Patient group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: GÜRKAN DEMİRTAŞ, Msc.
  phone: +90 388 311 2105
  email: gdemirtas255@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Nigde Omer Halisdemir University
  investigator full name: Gürkan Demirtas
  investigator title: Lecturer
  mesh term: Athletic Injuries
  sharing ipd: No