<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/NCT03784469</url>
  </required_header>
  <id_info>
    <org_study_id>201712022RIND</org_study_id>
    <nct_id>NCT03784469</nct_id>
  </id_info>
  <brief_title>Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC</brief_title>
  <official_title>Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Changing patients' position in the bed after TACE can decrease the level of back pain without&#xD;
      increasing the amount of bleeding and hematoma,bring patients some comfort and relieving&#xD;
      abdominal bloating, increase patients' satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background：During the treatment for the liver cancer patients who are treated by&#xD;
      Transcatheter Arterial Chemoembolization (TACE), the embolic agent with chemotherapeutic&#xD;
      drugs are injected through a catheter into a femoral artery directly supplying the tumor.&#xD;
      Hence, after the procedure, to avoid bleeding and hematoma at the puncture site, the puncture&#xD;
      site at groin needs to be pressed by sandbag and the affected limb needs to remain straight.&#xD;
      These patients have to lay down on beds and are not allowed to move for at least 4 hours. Due&#xD;
      to pressure exerted continuously to the same muscles, may cause back muscle rigidity and&#xD;
      spasms, these patients may suffer from back pain and discomfort. In addition to usual&#xD;
      pharmacological treatment, nursing intervention aimed at decreasing patient discomfort,&#xD;
      therefore, this study will refer to the previous researches to develop the methods and&#xD;
      procedures of changing body positions and apply these methods to the liver cancer patients&#xD;
      who are treated by TACE.&#xD;
&#xD;
      Purpose：The aim of this study was to compare the level of back pain and on the amount of&#xD;
      bleeding and hematoma between those patients changing body positions in bed and those&#xD;
      patients not changing body positions after TACE.&#xD;
&#xD;
      Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who&#xD;
      had undergone TACE via the femoral artery, patients by using a convenience sampling assigned&#xD;
      to either the control or experimental group (each group consisting 39 participants). All&#xD;
      patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2&#xD;
      hours and lie down for 4 hours. The control group received the usual care, remaining supine&#xD;
      position in complete bed rest and immobilized. Experimental group patients received position&#xD;
      changes in the second hour and the fourth hour after TACE.&#xD;
&#xD;
      Results: The overall trend of back pain is different between the two groups ( p &lt;.001) , the&#xD;
      mean of pain intensity in the second ( p =.006) and the forth hour ( p &lt;.001) showed a&#xD;
      significant difference. Experimental group patients had significantly less back pain than the&#xD;
      control group after TACE . For the within subjects factor of time, the levels of back pain&#xD;
      differed significantly across the five-time periods in experimental group ( p &lt; .05) . In the&#xD;
      aspect of post embolization syndrome , control group patients had significantly abdominal&#xD;
      bloating than the experimental group ( p =.003) . None of patients developed hematoma, there&#xD;
      was no significant difference between the two groups in terms of amount of bleeding. On the&#xD;
      whole, experimental group patients had significantly higher satisfaction than the control&#xD;
      group ( p =.018).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2018</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 28, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The overall trend of back pain</measure>
    <time_frame>Within 4 hours after TACE</time_frame>
    <description>The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mean of back pain between two groups</measure>
    <time_frame>Within 4 hours after TACE</time_frame>
    <description>The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS).To determine if there is any significant difference the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean of back pain in the experimental group</measure>
    <time_frame>Within 4 hours after TACE</time_frame>
    <description>To determine if there is any significant difference across the five-time periods in experimental group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean of back pain in the control group</measure>
    <time_frame>Within 4 hours after TACE</time_frame>
    <description>To determine if there is any significant difference across the five-time periods in control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.</time_frame>
    <description>The hematoma in femoral access site or there is blood on the yarn roll were visually checked, its margin was marked by a marker and its size was measured by using measuring paper. (The area equal to a square that is 1 millimeter on each side).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post embolization syndrome</measure>
    <time_frame>Within 4 hours after TACE.</time_frame>
    <description>This is a dichotomized variable. Various common symptoms were listed and checked off based on the patient's report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' satisfaction</measure>
    <time_frame>Patient's satisfaction will be evaluated at the 4th hour.</time_frame>
    <description>5-Point Likert Scale: with scores of 5, 4, 3, 2, and 1 indicating highly satisfied, satisfied, neutral, dissatisfied, and highly dissatisfied, respectively. Higher scores mean higher satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Liver Cancer</condition>
  <condition>Transcatheter Arterial Chemoembolization</condition>
  <arm_group>
    <arm_group_label>Changing body position in bed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No changing body position in bed,remaining supine position in complete bed rest and immobilized for four hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Changing body position in bed</intervention_name>
    <description>The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).</description>
    <arm_group_label>Changing body position in bed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with hepatocellular carcinoma hospitalized for TACE .&#xD;
&#xD;
          2. Age ≧ 18.&#xD;
&#xD;
          3. Consciousness can be communicated in Mandarin and Taiwanese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptoms of back pain before TACE.&#xD;
&#xD;
          2. Under the treatment of analagesics within 24 hours before TACE.&#xD;
&#xD;
          3. Anticoagulant was not discontinued for at least 7 days before TACE.&#xD;
&#xD;
          4. Inguinal hemorrhage or hematoma during the TACE or before removal of the vascular&#xD;
             sheath.&#xD;
&#xD;
          5. Hemological diseases that are prone to bleeding, i.e. hemophilia and leukemia.&#xD;
&#xD;
          6. Platelet count lower than 70K or INR (international normalized ratio) is greater than&#xD;
             1.4.&#xD;
&#xD;
          7. No hemostatic cotton use.&#xD;
&#xD;
          8. Can not change the position in bed after TACE.&#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>Tse-Pin Hsu, M.S.N.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcatheter Arterial Chemoembolization</keyword>
  <keyword>position change</keyword>
  <keyword>back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03784469
org study id: 201712022RIND
nct id: NCT03784469
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Changing patients' position in the bed after TACE can decrease the level of back pain without
      increasing the amount of bleeding and hematoma,bring patients some comfort and relieving
      abdominal bloating, increase patients' satisfaction.
Background：During the treatment for the liver cancer patients who are treated by
      Transcatheter Arterial Chemoembolization (TACE), the embolic agent with chemotherapeutic
      drugs are injected through a catheter into a femoral artery directly supplying the tumor.
      Hence, after the procedure, to avoid bleeding and hematoma at the puncture site, the puncture
      site at groin needs to be pressed by sandbag and the affected limb needs to remain straight.
      These patients have to lay down on beds and are not allowed to move for at least 4 hours. Due
      to pressure exerted continuously to the same muscles, may cause back muscle rigidity and
      spasms, these patients may suffer from back pain and discomfort. In addition to usual
      pharmacological treatment, nursing intervention aimed at decreasing patient discomfort,
      therefore, this study will refer to the previous researches to develop the methods and
      procedures of changing body positions and apply these methods to the liver cancer patients
      who are treated by TACE.

      Purpose：The aim of this study was to compare the level of back pain and on the amount of
      bleeding and hematoma between those patients changing body positions in bed and those
      patients not changing body positions after TACE.

      Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who
      had undergone TACE via the femoral artery, patients by using a convenience sampling assigned
      to either the control or experimental group (each group consisting 39 participants). All
      patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2
      hours and lie down for 4 hours. The control group received the usual care, remaining supine
      position in complete bed rest and immobilized. Experimental group patients received position
      changes in the second hour and the fourth hour after TACE.

      Results: The overall trend of back pain is different between the two groups ( p <.001) , the
      mean of pain intensity in the second ( p =.006) and the forth hour ( p <.001) showed a
      significant difference. Experimental group patients had significantly less back pain than the
      control group after TACE . For the within subjects factor of time, the levels of back pain
      differed significantly across the five-time periods in experimental group ( p < .05) . In the
      aspect of post embolization syndrome , control group patients had significantly abdominal
      bloating than the experimental group ( p =.003) . None of patients developed hematoma, there
      was no significant difference between the two groups in terms of amount of bleeding. On the
      whole, experimental group patients had significantly higher satisfaction than the control
      group ( p =.018).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: The overall trend of back pain
time frame: Within 4 hours after TACE
description: The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.
measure: The mean of back pain between two groups
time frame: Within 4 hours after TACE
description: The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS).To determine if there is any significant difference the two groups.
measure: The mean of back pain in the experimental group
time frame: Within 4 hours after TACE
description: To determine if there is any significant difference across the five-time periods in experimental group.
measure: The mean of back pain in the control group
time frame: Within 4 hours after TACE
description: To determine if there is any significant difference across the five-time periods in control group.
measure: Vascular complication
time frame: Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.
description: The hematoma in femoral access site or there is blood on the yarn roll were visually checked, its margin was marked by a marker and its size was measured by using measuring paper. (The area equal to a square that is 1 millimeter on each side).
measure: Post embolization syndrome
time frame: Within 4 hours after TACE.
description: This is a dichotomized variable. Various common symptoms were listed and checked off based on the patient's report.
measure: Patients' satisfaction
time frame: Patient's satisfaction will be evaluated at the 4th hour.
description: 5-Point Likert Scale: with scores of 5, 4, 3, 2, and 1 indicating highly satisfied, satisfied, neutral, dissatisfied, and highly dissatisfied, respectively. Higher scores mean higher satisfaction.
arm group label: Changing body position in bed
arm group type: Experimental
description: The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
arm group label: Control group
arm group type: No Intervention
description: No changing body position in bed,remaining supine position in complete bed rest and immobilized for four hours.
intervention type: Other
intervention name: Changing body position in bed
description: The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
arm group label: Changing body position in bed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tse-Pin Hsu, M.S.N.
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Back Pain