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/NCT05972811</url>
    </required_header>
    <id_info>
      <org_study_id>Karadeniz T. Uni.</org_study_id>
      <nct_id>NCT05972811</nct_id>
    </id_info>
    <brief_title>The Effect of Cold Application on Pain Developed Due to Drain Removal in Patients With Kidney Transplantation</brief_title>
    <official_title>Investigation of the Effect of Cold Application on Pain Caused by Jackson Pratt Drain Removal in Patients With Kidney Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karadeniz Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karadeniz Technical 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 study was planned as a prospective, randomized controlled study to examine the effect of&#xD;
        cold application on pain due to Jackson Pratt drain removal in kidney transplant patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During kidney transplant surgery, a Jackson Pratt Drain (JP) is placed in the surgical field&#xD;
        to monitor lymphocele and urinary leakage. This drain is a closed system that opens outward&#xD;
        from the skin at a point close to the incision line. This drain is removed by pulling when&#xD;
        the drainage amount falls below 30 ml. This procedure is known to cause serious pain. In our&#xD;
        study, which was planned as a prospective, randomized controlled study, it was aimed to&#xD;
        examine the effect of cold application in the pain caused by the removal of the JP drain in&#xD;
        patients with kidney transplantation. The population of the study will be patients who had a&#xD;
        kidney transplant in İstinye University Hospital Liv Hospital Organ Transplant Center (n=76).&#xD;
        In the study, patients will be assigned to the experimental and control groups by the block&#xD;
        randomization method. &quot;Patient Information Form&quot; and &quot;Visual Analog Scale&quot; (VAS) will be used&#xD;
        as data collection tools. In the experimental group, cold application will be made until the&#xD;
        skin temperature of the drain exit area reaches 13.6 °C. Then, the drain removal process will&#xD;
        be performed by the physician. In the control group, no application will be made. In both&#xD;
        study groups before drain removal, immediately after drain removal and 15 minutes later, pain&#xD;
        levels will be measured with VAS and analgesic needs will be questioned. Chi-square and&#xD;
        t-tests will be used to compare demographic data in the analysis process of the data. ANOVA&#xD;
        test will be applied to compare pain scores between groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Prospective, parallel randomized controlled clinical trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>The application will be made by the researcher. However, pain assessment will be done by the nurse who cares for the patient.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain evaluated using the Visual Analog Scale (VAS)</measure>
      <time_frame>Pain measurement will be made with VAS just before drain removal, immediately after drain removal, and 15 minutes later.</time_frame>
      <description>According to this scale, &quot;0&quot; indicates no pain, &quot;1-4&quot; indicates mild pain, &quot;5-6&quot; indicates moderate pain, and &quot;7-10&quot; indicates severe pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>Cold application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A frozen ice pack at -10 °C will be prepared for the patients in the experimental group. With these ice packs, the JP will be cooled to 13.6 °C, taking into account the literature, in order to create a local anesthetic effect on the drain outlet area before the drain is removed. Skin temperature will be measured intermittently with an infrared thermometer. When the skin temperature reaches 13.6 °C, the doctor will be informed and the drain will be removed. Before starting the cold application, immediately after the drain is removed, and after 15 minutes, considering the literature, pain will be measured with the &quot;Visual Analog Scale&quot;. By ensuring that the drain removal procedure is performed by the same physician, individual differences that may arise will be prevented.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No treatment will be applied to the patients in the control group. Pain measurement will be made with Visual Analog Scale before drain removal, immediately after drain removal, and 15 minutes later.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cold application</intervention_name>
      <description>In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. And before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned</description>
      <arm_group_label>Cold application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18-65,&#xD;
  &#xD;
            -  Being conscious, oriented to person, place and time,&#xD;
  &#xD;
            -  No history of mental pathology,&#xD;
  &#xD;
            -  No history of drug or alcohol use,&#xD;
  &#xD;
            -  Having a body mass index of &lt;30 kg/m2,&#xD;
  &#xD;
            -  Not using any analgesic or sedative medication one hour before drain removal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  IV analgesic or sedative treatment during cold application,&#xD;
  &#xD;
            -  Having a history of chronic pain,&#xD;
  &#xD;
            -  Having previous drain removal experience,&#xD;
  &#xD;
            -  Anxiety,&#xD;
  &#xD;
            -  Refusal to participate in the research,&#xD;
  &#xD;
            -  Unstable hemodynamic status.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dilek ÇİLİNGİR, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Karadeniz Technical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ufuk AKKURT, Master</last_name>
      <phone>+905462347351</phone>
      <email>akkurt8385@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karadeniz Technical University</name>
        <address>
          <city>Trabzon</city>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Ufuk AKKURT, Master</last_name>
        <phone>+905462347351</phone>
        <email>akkurt8385@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
      <investigator_full_name>Ufuk Akkurt</investigator_full_name>
      <investigator_title>PhD (c), Department of Nursing</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Pain Management</keyword>
    <keyword>Kidney Transplantation</keyword>
    <keyword>Drainage</keyword>
    <keyword>Cryotherapy</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/NCT05972811
  org study id: Karadeniz T. Uni.
  nct id: NCT05972811
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was planned as a prospective, randomized controlled study to examine the effect of
        cold application on pain due to Jackson Pratt drain removal in kidney transplant patients.
  During kidney transplant surgery, a Jackson Pratt Drain (JP) is placed in the surgical field
        to monitor lymphocele and urinary leakage. This drain is a closed system that opens outward
        from the skin at a point close to the incision line. This drain is removed by pulling when
        the drainage amount falls below 30 ml. This procedure is known to cause serious pain. In our
        study, which was planned as a prospective, randomized controlled study, it was aimed to
        examine the effect of cold application in the pain caused by the removal of the JP drain in
        patients with kidney transplantation. The population of the study will be patients who had a
        kidney transplant in İstinye University Hospital Liv Hospital Organ Transplant Center (n=76).
        In the study, patients will be assigned to the experimental and control groups by the block
        randomization method. "Patient Information Form" and "Visual Analog Scale" (VAS) will be used
        as data collection tools. In the experimental group, cold application will be made until the
        skin temperature of the drain exit area reaches 13.6 °C. Then, the drain removal process will
        be performed by the physician. In the control group, no application will be made. In both
        study groups before drain removal, immediately after drain removal and 15 minutes later, pain
        levels will be measured with VAS and analgesic needs will be questioned. Chi-square and
        t-tests will be used to compare demographic data in the analysis process of the data. ANOVA
        test will be applied to compare pain scores between groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, parallel randomized controlled clinical trial
  primary purpose: Supportive Care
  masking: Single (Care Provider)
  masking description: The application will be made by the researcher. However, pain assessment will be done by the nurse who cares for the patient.
  measure: Pain evaluated using the Visual Analog Scale (VAS)
  time frame: Pain measurement will be made with VAS just before drain removal, immediately after drain removal, and 15 minutes later.
  description: According to this scale, "0" indicates no pain, "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe pain.
  arm group label: Cold application
  arm group type: Experimental
  description: A frozen ice pack at -10 °C will be prepared for the patients in the experimental group. With these ice packs, the JP will be cooled to 13.6 °C, taking into account the literature, in order to create a local anesthetic effect on the drain outlet area before the drain is removed. Skin temperature will be measured intermittently with an infrared thermometer. When the skin temperature reaches 13.6 °C, the doctor will be informed and the drain will be removed. Before starting the cold application, immediately after the drain is removed, and after 15 minutes, considering the literature, pain will be measured with the "Visual Analog Scale". By ensuring that the drain removal procedure is performed by the same physician, individual differences that may arise will be prevented.
  arm group label: Control
  arm group type: No Intervention
  description: No treatment will be applied to the patients in the control group. Pain measurement will be made with Visual Analog Scale before drain removal, immediately after drain removal, and 15 minutes later.
  intervention type: Other
  intervention name: Cold application
  description: In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. And before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned
  arm group label: Cold application
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Dilek ÇİLİNGİR, Professor
  role: Study Director
  affiliation: Karadeniz Technical University
  last name: Ufuk AKKURT, Master
  phone: +905462347351
  email: akkurt8385@gmail.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Karadeniz Technical University
  investigator full name: Ufuk Akkurt
  investigator title: PhD (c), Department of Nursing
  sharing ipd: No