<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/NCT04425525</url>
  </required_header>
  <id_info>
    <org_study_id>MSc Thesis</org_study_id>
    <nct_id>NCT04425525</nct_id>
  </id_info>
  <brief_title>The Functional Difficulties Questionnaire-shortened Version: Turkish Translation, Validity and Reliability Study.</brief_title>
  <official_title>Adaptation of The Functional Difficulties Questionnaire-shortened Version Survey to Turkish and Determination of Psychometric Properties: Validity and Reliability Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muğla Sıtkı Koçman University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aydın Private Medinova Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Muğla Sıtkı Koçman 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 Functional Difficulties Questionnaire-shortened version &quot;(FDQ-s) is a unique&#xD;
      questionnaire that aimed at evaluating the functional performance of the upper extremities&#xD;
      and trunk following cardiothoracic surgery.&#xD;
&#xD;
      Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its&#xD;
      psychometric properties, validity and reliability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac surgeries performed by sternotomy method are the most common surgical treatment&#xD;
      method in coronary artery disease. Although the median sternotomy has advantages in terms of&#xD;
      ease of application, cost and long-term survival, muskuloskeletal complications can be&#xD;
      encountered in the postoperative period.&#xD;
&#xD;
      In the studies conducted, it was found that patients had difficulties in functional&#xD;
      activities including mobilization and daily life activities after median sternotomy. Also&#xD;
      restrictions or loss of motion can be observed in the joint range of motion of the shoulder&#xD;
      joint and thoracic region.&#xD;
&#xD;
      The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are&#xD;
      activities such as coughing, sneezing, deep breathing, movements involving the upper&#xD;
      extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s,&#xD;
      patients will mark how hard they are in each task on the 100 mm straight line. The first&#xD;
      point on the left means &quot;no difficulty&quot; and the last point on the right means &quot;maximum&#xD;
      difficulty&quot;. The score will be determined by measuring from the starting point to the place&#xD;
      marked by the patient. The total score is at most 100 points and at least 0 points. The high&#xD;
      score indicates that the patient's difficulty level is high.&#xD;
&#xD;
      Although there are many functional difficulties faced by patients in the postoperative&#xD;
      period, there is no outcome measurement in our language that evaluates the level of these&#xD;
      difficulties globally and objectively.&#xD;
&#xD;
      Our research will be done due to the elimination of this deficiency in the literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">June 18, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>15 Days</target_duration>
  <primary_outcome>
    <measure>Change of the Functional Status (with FDQ-s: Turkish version questionnaire)</measure>
    <time_frame>First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).</time_frame>
    <description>FDQ-S is a questionnaire created to evaluate the difficulties faced by patients undergoing cardiac surgery, especially when performing functional tasks of the thoracic region and upper extremity. The questionnaire consisting of 10 questions in total, the patients marked how much difficulty they had in each task, on a 100 mm straight line.The first point on the left means &quot;no difficulty&quot; and the last point on the right means &quot;maximum difficulty&quot;. The score was determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's strain level is high. With time frames we aimed to evaluate the change of the difficulty of patients function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)</measure>
    <time_frame>Day of discharge (post-op), 15th day after surgery (control day).</time_frame>
    <description>Barthel Index determines the level of addiction of the patient in 10 sections: nutrition, washing, self-care, dressing and bowel care, bladder care, toilet care, wheelchair to bed and vice versa, mobility (walking on a smooth surface, using the wheelchair: if appropriate), going up and down stairs.The total score is in the range of 0-100, which means 0-20 points: fully dependent, 21-61: highly dependent, 62-90: moderately dependent, 91-99: slightly dependent, 100 points: fully independent.With time frames we aimed to evaluate the change of the mobility scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)</measure>
    <time_frame>Day of discharge (post-op), 15th day after surgery (control day).</time_frame>
    <description>SF-36 is the most common scale used to measure individuals' quality of life. This scale examines 8 dimensions of health with 36 items such as physical function, role restrictions (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health.Instead of giving only one total score, the scale gives total score separately for each subscale.100 points indicate good health, 0 points indicate bad health. With time frame we aimed to evaluate the cange of the life quality score of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Pain Status: (Visual Analogue Scale)</measure>
    <time_frame>First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).</time_frame>
    <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between &quot;no pain&quot; and &quot;worst pain.&quot; The distance from the 0 point to the place marked by the patient indicates the pain of the patient. With time frame we aimed to evaluate the change of the life quality score of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Mobility Status: (Perme Intensive Care Mobility Score)</measure>
    <time_frame>Day of discharge (post-op), 15th day after surgery (control day).</time_frame>
    <description>The Perme ICU Mobility Score is a tool developed to measure the patient's mobility status starting with the ability to follow commands and culminating in the distance walked in two minutes. A total score of 3 or 4 is given for each item, reflecting the patient's mobility. A high score indicates a small amount of mobility barrier and low help, while a low score indicates more mobility and more help needed for mobility. With time frame we aimed to evaluate the change of the mobility score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>First day at the hospital (pre-op)</time_frame>
    <description>Age (Year)</description>
  </other_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>First day at the hospital (pre-op)</time_frame>
    <description>Height in meters</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>First day at the hospital</time_frame>
    <description>BMI (weight and height combined to report BMI in kg/m²)</description>
  </other_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Functional Status After CABG Surgery</condition>
  <condition>Outcome Measure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Having undergone coronary artery bypass surgery with median sternotomi&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being over the age of 18&#xD;
&#xD;
          -  Having undergone coronary artery bypass surgery (via median sternotomi)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having ability to read and write in Turkish&#xD;
&#xD;
          -  Having cognitive impairment&#xD;
&#xD;
          -  Being in the intensive care unit for more than five days due to medical reasons.&#xD;
&#xD;
          -  Having undergone surgery involving thorax or upper extremity in the last 6 months.&#xD;
&#xD;
          -  Having neurologic or musculoskeletal problems to prevent evaluation, ambulation and&#xD;
             exercise.&#xD;
&#xD;
          -  Patients who have an infection or unhealed scar after surgery even if their first&#xD;
             measurements are made&#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_official>
    <last_name>Ayşe Adıgüzel Bayar, MSc Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Muğla Sıtkı Koçman University/ Private Medinova Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Baki Umut Tuğay, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Muğla Sıtkı Koçman University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Private Medinova Hospital</name>
      <address>
        <city>Aydın</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
    <investigator_full_name>Ayşe Adıgüzel Bayar</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>heart surgery, function, measure, validity, reliability.</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04425525
org study id: MSc Thesis
nct id: NCT04425525
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The Functional Difficulties Questionnaire-shortened version "(FDQ-s) is a unique
      questionnaire that aimed at evaluating the functional performance of the upper extremities
      and trunk following cardiothoracic surgery.

      Aim of this study is adaptation of the FDQ-s questionnaire to Turkish culture and study its
      psychometric properties, validity and reliability.
Cardiac surgeries performed by sternotomy method are the most common surgical treatment
      method in coronary artery disease. Although the median sternotomy has advantages in terms of
      ease of application, cost and long-term survival, muskuloskeletal complications can be
      encountered in the postoperative period.

      In the studies conducted, it was found that patients had difficulties in functional
      activities including mobilization and daily life activities after median sternotomy. Also
      restrictions or loss of motion can be observed in the joint range of motion of the shoulder
      joint and thoracic region.

      The FDQ-s scale consists of 10 functional tasks developed by Sturgess et al. These tasks are
      activities such as coughing, sneezing, deep breathing, movements involving the upper
      extremity, turning in bed, sitting upright in the chair, and ambulation. When applying FDQ-s,
      patients will mark how hard they are in each task on the 100 mm straight line. The first
      point on the left means "no difficulty" and the last point on the right means "maximum
      difficulty". The score will be determined by measuring from the starting point to the place
      marked by the patient. The total score is at most 100 points and at least 0 points. The high
      score indicates that the patient's difficulty level is high.

      Although there are many functional difficulties faced by patients in the postoperative
      period, there is no outcome measurement in our language that evaluates the level of these
      difficulties globally and objectively.

      Our research will be done due to the elimination of this deficiency in the literature.
observational model: Case-Only
time perspective: Other
measure: Change of the Functional Status (with FDQ-s: Turkish version questionnaire)
time frame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control).
description: FDQ-S is a questionnaire created to evaluate the difficulties faced by patients undergoing cardiac surgery, especially when performing functional tasks of the thoracic region and upper extremity. The questionnaire consisting of 10 questions in total, the patients marked how much difficulty they had in each task, on a 100 mm straight line.The first point on the left means "no difficulty" and the last point on the right means "maximum difficulty". The score was determined by measuring from the starting point to the place marked by the patient. The total score is at most 100 points and at least 0 points. The high score indicates that the patient's strain level is high. With time frames we aimed to evaluate the change of the difficulty of patients function.
measure: Change of the Mobility Status : (Barthel İndex of Activities of Daily Living)
time frame: Day of discharge (post-op), 15th day after surgery (control day).
description: Barthel Index determines the level of addiction of the patient in 10 sections: nutrition, washing, self-care, dressing and bowel care, bladder care, toilet care, wheelchair to bed and vice versa, mobility (walking on a smooth surface, using the wheelchair: if appropriate), going up and down stairs.The total score is in the range of 0-100, which means 0-20 points: fully dependent, 21-61: highly dependent, 62-90: moderately dependent, 91-99: slightly dependent, 100 points: fully independent.With time frames we aimed to evaluate the change of the mobility scores.
measure: Change of the Quality of Life Status: (SF-36 Quality of Life Questionnaire)
time frame: Day of discharge (post-op), 15th day after surgery (control day).
description: SF-36 is the most common scale used to measure individuals' quality of life. This scale examines 8 dimensions of health with 36 items such as physical function, role restrictions (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health.Instead of giving only one total score, the scale gives total score separately for each subscale.100 points indicate good health, 0 points indicate bad health. With time frame we aimed to evaluate the cange of the life quality score of patients.
measure: Change of the Pain Status: (Visual Analogue Scale)
time frame: First day at the hospital (pre-op), day of discharge (post-op), 15th day after surgery (control day).
description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance from the 0 point to the place marked by the patient indicates the pain of the patient. With time frame we aimed to evaluate the change of the life quality score of patients.
measure: Change of the Mobility Status: (Perme Intensive Care Mobility Score)
time frame: Day of discharge (post-op), 15th day after surgery (control day).
description: The Perme ICU Mobility Score is a tool developed to measure the patient's mobility status starting with the ability to follow commands and culminating in the distance walked in two minutes. A total score of 3 or 4 is given for each item, reflecting the patient's mobility. A high score indicates a small amount of mobility barrier and low help, while a low score indicates more mobility and more help needed for mobility. With time frame we aimed to evaluate the change of the mobility score.
measure: Age
time frame: First day at the hospital (pre-op)
description: Age (Year)
measure: Height
time frame: First day at the hospital (pre-op)
description: Height in meters
measure: BMI
time frame: First day at the hospital
description: BMI (weight and height combined to report BMI in kg/m²)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ayşe Adıgüzel Bayar, MSc Student
role: Principal Investigator
affiliation: Muğla Sıtkı Koçman University/ Private Medinova Hospital
last name: Baki Umut Tuğay, Prof. Dr.
role: Study Director
affiliation: Muğla Sıtkı Koçman University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Muğla Sıtkı Koçman University
investigator full name: Ayşe Adıgüzel Bayar
investigator title: Physiotherapist
sharing ipd: Undecided