<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/NCT03807960</url>
  </required_header>
  <id_info>
    <org_study_id>pcı</org_study_id>
    <nct_id>NCT03807960</nct_id>
  </id_info>
  <brief_title>Information for Patient Controlled Analgesia Device</brief_title>
  <official_title>The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tuğba Karaman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tokat Gaziosmanpasa University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tokat Gaziosmanpasa 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>
      This study is aimed to show the effect of information method on properly usage of the patient&#xD;
      controlled analgesia(PCA) device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is&#xD;
      an effective method for postoperative pain management. However, most of the patient can not&#xD;
      use the device properly. The important cause of inabilities about device usage is&#xD;
      insufficient information.In the patient information, visual, oral or written communication&#xD;
      methods can be chosen. However, which method is suitable for our patient group is not&#xD;
      clear.This study is aimed to show the effect of information method on properly usage of the&#xD;
      patient controlled analgesia(PCA) device&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</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>Pain Score</measure>
    <time_frame>At postoperative 24th hours.</time_frame>
    <description>Numeric rating scale (0 to 10) will be used for postoperative pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative analgesic consumption</measure>
    <time_frame>Up to the postoperative 24th hours.</time_frame>
    <description>Total opioid dosage will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCA device usage</measure>
    <time_frame>During postoperative 24 hours</time_frame>
    <description>The number of demand dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCA device demand dose duration</measure>
    <time_frame>During postoperative 24hours</time_frame>
    <description>The duration of the patients' demanding dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction</measure>
    <time_frame>At the postoperative 24th hours</time_frame>
    <description>The numeric rating scale (0 to 10) will be used. In this scale 0 will be the worst, 10 will be the best satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the postoperative pain score</measure>
    <time_frame>Up to the postoperative 24th hours.</time_frame>
    <description>Numeric rating scale (0 to 10) will be used to evaluate the pain score. The change in this score during postoperative 24 hours will be calculated.(the first score will be extracted from the last score)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of stay hospital</measure>
    <time_frame>Up to the postoperative 10 days</time_frame>
    <description>Number of the day that patients stay at hospital will be recorded.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Postoperative Care</condition>
  <condition>Hysterectomy</condition>
  <condition>Health Communication</condition>
  <arm_group>
    <arm_group_label>visual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>written</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The written form which include the same knowledge will give to the patient for reading.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The anesthesiologist will describe the PCA usage as in the routine care to the control group patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>written form</intervention_name>
    <description>The written form which include PCA usage information.</description>
    <arm_group_label>written</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>video</intervention_name>
    <description>The video about PCA usage</description>
    <arm_group_label>visual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>routine care</intervention_name>
    <description>The routine description about PCA usage</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  Elective hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opioid abuse or Chronic opioid usage&#xD;
&#xD;
          -  opioid allergy&#xD;
&#xD;
          -  obesity(BMI&gt;30)&#xD;
&#xD;
          -  psychiatric disease&#xD;
&#xD;
          -  more than American Anesthesiologist Score 2&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serkan Karaman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gaziosmanpasa University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gaziosmanpasa University Hospital</name>
      <address>
        <city>Tokat</city>
        <state>Merkez</state>
        <zip>60100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
    <investigator_full_name>Tuğba Karaman</investigator_full_name>
    <investigator_title>Associate Professor,MD</investigator_title>
  </responsible_party>
  <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/NCT03807960
org study id: pcı
nct id: NCT03807960
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is aimed to show the effect of information method on properly usage of the patient
      controlled analgesia(PCA) device
Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is
      an effective method for postoperative pain management. However, most of the patient can not
      use the device properly. The important cause of inabilities about device usage is
      insufficient information.In the patient information, visual, oral or written communication
      methods can be chosen. However, which method is suitable for our patient group is not
      clear.This study is aimed to show the effect of information method on properly usage of the
      patient controlled analgesia(PCA) device
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Pain Score
time frame: At postoperative 24th hours.
description: Numeric rating scale (0 to 10) will be used for postoperative pain score
measure: Postoperative analgesic consumption
time frame: Up to the postoperative 24th hours.
description: Total opioid dosage will be recorded
measure: PCA device usage
time frame: During postoperative 24 hours
description: The number of demand dose
measure: PCA device demand dose duration
time frame: During postoperative 24hours
description: The duration of the patients' demanding dose
measure: Patient's satisfaction
time frame: At the postoperative 24th hours
description: The numeric rating scale (0 to 10) will be used. In this scale 0 will be the worst, 10 will be the best satisfaction.
measure: The change of the postoperative pain score
time frame: Up to the postoperative 24th hours.
description: Numeric rating scale (0 to 10) will be used to evaluate the pain score. The change in this score during postoperative 24 hours will be calculated.(the first score will be extracted from the last score)
measure: Length of stay hospital
time frame: Up to the postoperative 10 days
description: Number of the day that patients stay at hospital will be recorded.
arm group label: visual
arm group type: Experimental
description: The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook.
arm group label: written
arm group type: Experimental
description: The written form which include the same knowledge will give to the patient for reading.
arm group label: control
arm group type: Other
description: The anesthesiologist will describe the PCA usage as in the routine care to the control group patients.
intervention type: Other
intervention name: written form
description: The written form which include PCA usage information.
arm group label: written
intervention type: Other
intervention name: video
description: The video about PCA usage
arm group label: visual
intervention type: Other
intervention name: routine care
description: The routine description about PCA usage
arm group label: control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Serkan Karaman, MD
role: Principal Investigator
affiliation: Gaziosmanpasa University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Tokat Gaziosmanpasa University
investigator full name: Tuğba Karaman
investigator title: Associate Professor,MD
sharing ipd: Undecided