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/NCT05979402</url>
    </required_header>
    <id_info>
      <org_study_id>AIBU-HEM-UZUN-004</org_study_id>
      <nct_id>NCT05979402</nct_id>
    </id_info>
    <brief_title>The Effect of Pressure Ulcer Education on the Knowledge Level of the Relatives of the Patients</brief_title>
    <official_title>Effectiveness of Pressure Wound Prevention Training for the Relatives of Palliative Care Patients: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abant Izzet Baysal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Abant Izzet Baysal University</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this randomized controlled trial, which included pretest and posttest, was to&#xD;
        examine the effectiveness of pressure ulcer prevention and care education given to caregivers&#xD;
        of patients treated in a palliative care clinic.&#xD;
  &#xD;
        The key questions it aims to answer are:&#xD;
  &#xD;
          -  Does the routine clinical training given in the palliative care clinic have an effect on&#xD;
             the knowledge level of patients' relatives about pressure ulcers?&#xD;
  &#xD;
          -  Does the pressure ulcer education given to the relatives of patients treated in the&#xD;
             palliative care clinic have an effect on the level of knowledge about pressure ulcers?&#xD;
  &#xD;
        Participants will participate in an educational activity on pressure ulcers. Researchers will&#xD;
        compare whether pressure ulcer training given to palliative care patient relatives is&#xD;
        effective compared to routine service training with lecture, question-answer and presentation&#xD;
        method.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One-to-one interviews will be conducted with the relatives of the patients in the&#xD;
        experimental and control groups, and the appropriate time frame for the clinical operation&#xD;
        will be determined. Participants will be informed about the study at the time determined&#xD;
        jointly with the companions and at the appropriate place for the clinic.&#xD;
  &#xD;
        Personal Information Form and Pressure Ulcer Information Test will be distributed and&#xD;
        collected as a pre-test to the participants in the control group. The participants in the&#xD;
        control group will not receive any educational intervention by the researcher until the day&#xD;
        of discharge. This group will receive routine clinical training given only in the hospital.&#xD;
        Training of patients and their relatives in clinics continues with the principle of&#xD;
        &quot;Do-Watch-Check&quot;. This is how nurses conduct their routine clinical training. The Pressure&#xD;
        Ulcer Information Test will be distributed and collected as a post-test to the control group&#xD;
        on the day of the patients' discharge.&#xD;
  &#xD;
        Personal Information Form and Pressure Ulcer Information Test will be distributed and&#xD;
        collected as a pre-test to the participants in the experimental group. In addition to the&#xD;
        training given to the participants in the experimental group with the routine&#xD;
        &quot;Do-Watch-Check&quot; principle in the clinic, face-to-face pressure ulcer training will be given&#xD;
        by the researchers on the day of discharge. The presentation about the pressure ulcer will be&#xD;
        given by the researchers in two periods of 30 min + 30 minutes using lectures, case studies&#xD;
        and question-answer techniques. Opinions were received from three field experts regarding the&#xD;
        validity of the training content of the pressure ulcer topic (CGI: 1.00). The Pressure Ulcer&#xD;
        Knowledge Test will be redistributed and collected as a final test on the day of discharge&#xD;
        after completion of training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>
      <intervention_model_description>This study is a randomized controlled study with experimental and control groups consisting of pre-test and post-test</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome evaluations will be conducted by a researcher blinded to group allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pressure ulcer information of palliative care patients' relatives: First test</measure>
      <time_frame>Just before training</time_frame>
      <description>&quot;Pressure Ulcer Knowledge Test&quot; is a test prepared by researchers in line with the literature and sent to three expert academicians to ensure content validity. Pressure Ulcer Knowledge Test is a 3-point Likert-type questionnaire consisting of 17 questions coded as true, false, I don't know. Five of the questions in the test were designed to be scored reversely and 12 of them were scored straight. The score to be taken from the test is between 0-17. A high score indicates that the relatives of the patients have a high level of knowledge about pressure ulcers, and a low score indicates a low level of knowledge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pressure ulcer information of palliative care patients' relatives: Second test</measure>
      <time_frame>Immediately after training</time_frame>
      <description>&quot;Pressure Ulcer Knowledge Test&quot; is a test prepared by researchers in line with the literature and sent to three expert academicians to ensure content validity. Pressure Ulcer Knowledge Test is a 3-point Likert-type questionnaire consisting of 17 questions coded as true, false, I don't know. Five of the questions in the test were designed to be scored reversely and 12 of them were scored straight. The score to be taken from the test is between 0-17. A high score indicates that the relatives of the patients have a high level of knowledge about pressure ulcers, and a low score indicates a low level of knowledge.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Face-to-face pressure ulcer training will be given to the relatives of the patients in the training group in the determined common time period. The presentation and pressure ulcer content prepared during the trainings will be conveyed by the researcher in two 30-minute sessions using lectures, example events and question-answer techniques.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the control group will not be interfered with by the researcher during the research. They will receive routine in-clinic training given by nurses.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Training group Face-to-face pressure ulcer training</intervention_name>
      <description>Face-to-face presure ulcer training</description>
      <arm_group_label>Training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control group</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who agree to participate in the study&#xD;
  &#xD;
            -  Native Turkish,&#xD;
  &#xD;
            -  18 years and over&#xD;
  &#xD;
            -  Able to read and write&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Who refused to participate in the study&#xD;
  &#xD;
            -  Native language is not Turkish&#xD;
  &#xD;
            -  Illiterate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lütfiye Nur Uzun, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hümeyra Hançer Tok, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lütfiye Nur Uzun, PhD</last_name>
      <phone>+905441088353</phone>
      <email>nuruzun53@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hümeyra Hançer Tok, PhD</last_name>
      <phone>+905446004410</phone>
      <email>hancertok@gmail.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Abant Izzet Baysal University</investigator_affiliation>
      <investigator_full_name>Lutfiye Nur Uzun</investigator_full_name>
      <investigator_title>PhD</investigator_title>
    </responsible_party>
    <keyword>Pressure Ulcer</keyword>
    <keyword>Caregiver Education</keyword>
    <keyword>Palliative Care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pressure Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No IPD will be shared with other researchers.</ipd_description>
    </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/NCT05979402
  org study id: AIBU-HEM-UZUN-004
  nct id: NCT05979402
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this randomized controlled trial, which included pretest and posttest, was to
        examine the effectiveness of pressure ulcer prevention and care education given to caregivers
        of patients treated in a palliative care clinic.
  
        The key questions it aims to answer are:
  
          -  Does the routine clinical training given in the palliative care clinic have an effect on
             the knowledge level of patients' relatives about pressure ulcers?
  
          -  Does the pressure ulcer education given to the relatives of patients treated in the
             palliative care clinic have an effect on the level of knowledge about pressure ulcers?
  
        Participants will participate in an educational activity on pressure ulcers. Researchers will
        compare whether pressure ulcer training given to palliative care patient relatives is
        effective compared to routine service training with lecture, question-answer and presentation
        method.
  One-to-one interviews will be conducted with the relatives of the patients in the
        experimental and control groups, and the appropriate time frame for the clinical operation
        will be determined. Participants will be informed about the study at the time determined
        jointly with the companions and at the appropriate place for the clinic.
  
        Personal Information Form and Pressure Ulcer Information Test will be distributed and
        collected as a pre-test to the participants in the control group. The participants in the
        control group will not receive any educational intervention by the researcher until the day
        of discharge. This group will receive routine clinical training given only in the hospital.
        Training of patients and their relatives in clinics continues with the principle of
        "Do-Watch-Check". This is how nurses conduct their routine clinical training. The Pressure
        Ulcer Information Test will be distributed and collected as a post-test to the control group
        on the day of the patients' discharge.
  
        Personal Information Form and Pressure Ulcer Information Test will be distributed and
        collected as a pre-test to the participants in the experimental group. In addition to the
        training given to the participants in the experimental group with the routine
        "Do-Watch-Check" principle in the clinic, face-to-face pressure ulcer training will be given
        by the researchers on the day of discharge. The presentation about the pressure ulcer will be
        given by the researchers in two periods of 30 min + 30 minutes using lectures, case studies
        and question-answer techniques. Opinions were received from three field experts regarding the
        validity of the training content of the pressure ulcer topic (CGI: 1.00). The Pressure Ulcer
        Knowledge Test will be redistributed and collected as a final test on the day of discharge
        after completion of training.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a randomized controlled study with experimental and control groups consisting of pre-test and post-test
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: Outcome evaluations will be conducted by a researcher blinded to group allocation.
  measure: Pressure ulcer information of palliative care patients' relatives: First test
  time frame: Just before training
  description: "Pressure Ulcer Knowledge Test" is a test prepared by researchers in line with the literature and sent to three expert academicians to ensure content validity. Pressure Ulcer Knowledge Test is a 3-point Likert-type questionnaire consisting of 17 questions coded as true, false, I don't know. Five of the questions in the test were designed to be scored reversely and 12 of them were scored straight. The score to be taken from the test is between 0-17. A high score indicates that the relatives of the patients have a high level of knowledge about pressure ulcers, and a low score indicates a low level of knowledge.
  measure: Pressure ulcer information of palliative care patients' relatives: Second test
  time frame: Immediately after training
  description: "Pressure Ulcer Knowledge Test" is a test prepared by researchers in line with the literature and sent to three expert academicians to ensure content validity. Pressure Ulcer Knowledge Test is a 3-point Likert-type questionnaire consisting of 17 questions coded as true, false, I don't know. Five of the questions in the test were designed to be scored reversely and 12 of them were scored straight. The score to be taken from the test is between 0-17. A high score indicates that the relatives of the patients have a high level of knowledge about pressure ulcers, and a low score indicates a low level of knowledge.
  arm group label: Training group
  arm group type: Experimental
  description: Face-to-face pressure ulcer training will be given to the relatives of the patients in the training group in the determined common time period. The presentation and pressure ulcer content prepared during the trainings will be conveyed by the researcher in two 30-minute sessions using lectures, example events and question-answer techniques.
  arm group label: Control group
  arm group type: Active Comparator
  description: Participants in the control group will not be interfered with by the researcher during the research. They will receive routine in-clinic training given by nurses.
  intervention type: Other
  intervention name: Training group Face-to-face pressure ulcer training
  description: Face-to-face presure ulcer training
  arm group label: Training group
  intervention type: Other
  intervention name: Control group
  description: No intervention
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lütfiye Nur Uzun, PhD
  role: Principal Investigator
  affiliation: Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department
  last name: Hümeyra Hançer Tok, PhD
  role: Principal Investigator
  affiliation: Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department
  last name: Lütfiye Nur Uzun, PhD
  phone: +905441088353
  email: nuruzun53@gmail.com
  last name: Hümeyra Hançer Tok, PhD
  phone: +905446004410
  email: hancertok@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Abant Izzet Baysal University
  investigator full name: Lutfiye Nur Uzun
  investigator title: PhD
  mesh term: Pressure Ulcer
  sharing ipd: No
  ipd description: No IPD will be shared with other researchers.