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/NCT05994222</url>
    </required_header>
    <id_info>
      <org_study_id>22-120</org_study_id>
      <nct_id>NCT05994222</nct_id>
    </id_info>
    <brief_title>State Mindfulness Scale for Physical Activity: Validity and Reliability</brief_title>
    <official_title>Turkish Translation of State Mindfulness Scale for Physical Activity; Validity, Reliability, and Cultural Adaptation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istinye University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istinye 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>
        The American College of Sports Medicine (ACSM) states that physical activity is very&#xD;
        important for healthy adults as it provides many health and psychological benefits. Physical&#xD;
        activity is any bodily movement produced by skeletal muscles that increases energy&#xD;
        expenditure. physical activity; It is an important health behavior that can have a positive&#xD;
        impact on physical, cognitive, and social well-being. In the population of athletes who&#xD;
        qualify as physically active, the focus is not on adapting to exercise or improving physical&#xD;
        activity. However, the inability of athletes to maintain their lifelong physical activity&#xD;
        levels after retirement can cause health problems. Because physical activity behavior&#xD;
        patterns are lifelong, it is important to understand the factors that contribute to physical&#xD;
        activity.&#xD;
  &#xD;
        Conscious awareness; It is defined as a mindset in the form of being aware of the present&#xD;
        moment with the features that do not judge, accept and avoid. Mindfulness is often said to&#xD;
        require both purposeful attention and an accepting attitude. Intention is also considered an&#xD;
        important part of awareness. There is increasing interest in the role of mindfulness in the&#xD;
        emergence of positive health outcomes. One possible benefit of mindful practice is that it&#xD;
        can lead to intrinsic motivation. Until recently, there was no good way to measure the&#xD;
        specific experience of mindfulness during physical activity to support this recommendation. A&#xD;
        new scale called the State Mindfulness Scale for Physical Activity has been developed to help&#xD;
        researchers better understand how people feel about their physical activity.&#xD;
  &#xD;
        The State Mindfulness Scale for Physical Activity is a 12-item scale to measure mindfulness&#xD;
        during a specific physical activity. The scale is based on the Situational Conscious&#xD;
        Awareness Scale, which measures objects (mental and physical) and the quality of situational&#xD;
        conscious awareness. The original scale was not comprehensive enough to capture the full&#xD;
        spectrum of physical experiences. The State Mindfulness Scale for Physical Activity was&#xD;
        developed to assess different aspects of mindfulness (mental and physical) during physical&#xD;
        activity to better understand the physical activity experience. There are six items that use&#xD;
        awareness of objects of mental experience and six items that use awareness of objects of&#xD;
        physical or physical experience. State Mindfulness Scale for Physical Activity has been&#xD;
        successfully adapted to Spanish, Italian and Brazilian.&#xD;
  &#xD;
        Despite the increase in Turkish assessment tools in the field of physical activity in recent&#xD;
        years, psychological assessment tools are very few. The aim of this study is to translate,&#xD;
        culturally adapt and validate the Turkish version of the State Mindfulness Scale for Physical&#xD;
        Activity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Actual">September 2, 2023</completion_date>
    <primary_completion_date type="Actual">August 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>State Mindfulness Scale for Physical Activity</measure>
      <time_frame>2 weeks</time_frame>
      <description>It was developed by Cox et al (2015). It is a 12-item scale used to measure conscious awareness during a specific physical activity. The scale is based on the State Mindfulness Scale for Physical Activity, which measures objects (mental and physical) and the quality of situational conscious awareness. The State Mindfulness Scale for Physical Activitywas developed to assess different aspects of mindfulness (mental and physical) during physical activity in order to better understand the physical activity experience. Six items use awareness of objects of mental experience and six items use awareness of objects of physical or physical experience.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Behavioral Regulations in Exercise Scale-2</measure>
      <time_frame>2 weeks</time_frame>
      <description>It consists of 19 items and five subscales. These are: external regulation, introjected regulation, defined regulation, internal regulation and amotivation subscales. The external regulation and internal regulation subscales consist of four items, while the introjected regulation and defined regulation subscales consist of three items. The unmotivated subscale consists of 4 items. It is a 5-point Likert-type scale with scores ranging from 0 to 4, consisting of &quot;definitely not true&quot;, &quot;sometimes true&quot; and &quot;definitely true&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire Short Form</measure>
      <time_frame>2 weeks</time_frame>
      <description>In our study, the self-administered short form of the questionnaire with 7 questions covering the last 1 week will be used to evaluate the level of physical activity. Calculation of the total score of the short form includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The sitting score is calculated separately. A score is obtained as &quot;MET-minutes/week&quot; by multiplying the minutes, days and MET values.</description>
    </primary_outcome>
    <enrollment type="Actual">132</enrollment>
    <condition>Physical Inactivity</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessment Group</intervention_name>
      <description>Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy volunteers aged 18-35&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be a licensed athlete between the ages of 18 and 35&#xD;
  &#xD;
            -  Be literate in Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having an ongoing injury&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istinye University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>physical activity</keyword>
    <keyword>mindfulness</keyword>
    <keyword>cultural adaptation</keyword>
    <keyword>validity</keyword>
    <keyword>relability</keyword>
    <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/NCT05994222
  org study id: 22-120
  nct id: NCT05994222
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The American College of Sports Medicine (ACSM) states that physical activity is very
        important for healthy adults as it provides many health and psychological benefits. Physical
        activity is any bodily movement produced by skeletal muscles that increases energy
        expenditure. physical activity; It is an important health behavior that can have a positive
        impact on physical, cognitive, and social well-being. In the population of athletes who
        qualify as physically active, the focus is not on adapting to exercise or improving physical
        activity. However, the inability of athletes to maintain their lifelong physical activity
        levels after retirement can cause health problems. Because physical activity behavior
        patterns are lifelong, it is important to understand the factors that contribute to physical
        activity.
  
        Conscious awareness; It is defined as a mindset in the form of being aware of the present
        moment with the features that do not judge, accept and avoid. Mindfulness is often said to
        require both purposeful attention and an accepting attitude. Intention is also considered an
        important part of awareness. There is increasing interest in the role of mindfulness in the
        emergence of positive health outcomes. One possible benefit of mindful practice is that it
        can lead to intrinsic motivation. Until recently, there was no good way to measure the
        specific experience of mindfulness during physical activity to support this recommendation. A
        new scale called the State Mindfulness Scale for Physical Activity has been developed to help
        researchers better understand how people feel about their physical activity.
  
        The State Mindfulness Scale for Physical Activity is a 12-item scale to measure mindfulness
        during a specific physical activity. The scale is based on the Situational Conscious
        Awareness Scale, which measures objects (mental and physical) and the quality of situational
        conscious awareness. The original scale was not comprehensive enough to capture the full
        spectrum of physical experiences. The State Mindfulness Scale for Physical Activity was
        developed to assess different aspects of mindfulness (mental and physical) during physical
        activity to better understand the physical activity experience. There are six items that use
        awareness of objects of mental experience and six items that use awareness of objects of
        physical or physical experience. State Mindfulness Scale for Physical Activity has been
        successfully adapted to Spanish, Italian and Brazilian.
  
        Despite the increase in Turkish assessment tools in the field of physical activity in recent
        years, psychological assessment tools are very few. The aim of this study is to translate,
        culturally adapt and validate the Turkish version of the State Mindfulness Scale for Physical
        Activity.
  observational model: Case-Only
  time perspective: Prospective
  measure: State Mindfulness Scale for Physical Activity
  time frame: 2 weeks
  description: It was developed by Cox et al (2015). It is a 12-item scale used to measure conscious awareness during a specific physical activity. The scale is based on the State Mindfulness Scale for Physical Activity, which measures objects (mental and physical) and the quality of situational conscious awareness. The State Mindfulness Scale for Physical Activitywas developed to assess different aspects of mindfulness (mental and physical) during physical activity in order to better understand the physical activity experience. Six items use awareness of objects of mental experience and six items use awareness of objects of physical or physical experience.
  measure: Behavioral Regulations in Exercise Scale-2
  time frame: 2 weeks
  description: It consists of 19 items and five subscales. These are: external regulation, introjected regulation, defined regulation, internal regulation and amotivation subscales. The external regulation and internal regulation subscales consist of four items, while the introjected regulation and defined regulation subscales consist of three items. The unmotivated subscale consists of 4 items. It is a 5-point Likert-type scale with scores ranging from 0 to 4, consisting of "definitely not true", "sometimes true" and "definitely true".
  measure: International Physical Activity Questionnaire Short Form
  time frame: 2 weeks
  description: In our study, the self-administered short form of the questionnaire with 7 questions covering the last 1 week will be used to evaluate the level of physical activity. Calculation of the total score of the short form includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The sitting score is calculated separately. A score is obtained as "MET-minutes/week" by multiplying the minutes, days and MET values.
  intervention type: Other
  intervention name: Assessment Group
  description: Evaluation forms will be applied to the participant who meets the inclusion criteria by face-to-face interview method. The sociodemographic information of the participants and the time taken to answer the questions in the questionnaires will vary according to each participants but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1-week intervals.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Sponsor
  sharing ipd: No