<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/NCT03840356</url>
  </required_header>
  <id_info>
    <org_study_id>18-004244</org_study_id>
    <nct_id>NCT03840356</nct_id>
  </id_info>
  <brief_title>Postoperative Pain Reported to Nurses and Physicians</brief_title>
  <official_title>Comparison of Postoperative Pain Scores Reported by Patients to the Surgical Teams and Nursing Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Effective pain control following surgical procedures is a goal for both the patient as well&#xD;
      as the medical staff caring for them. There have been numerous studies evaluating differing&#xD;
      treatment pathways, but most studies have relied on the Visual Analog Scale (VAS) or&#xD;
      Numerical Rating Scale (NRS) to evaluate outcomes. These scales are subjective score given by&#xD;
      the patient with no objective data input, therefore making comparisons subject to possible&#xD;
      bias. There are no known studies comparing the pain scores provided by the patient to the&#xD;
      surgical team compared to the nursing staff caring for the patient. The aim will be to&#xD;
      compare these values to see if patients are consistent in their pain rating.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project will be conducted as a prospective study comparing numerical rating scale pain&#xD;
      scores reported by the patients to the surgical team and the nursing staff. All orthopedic&#xD;
      inpatients will be eligible for the study. Subjects will not be consented for the study prior&#xD;
      to data collection in order to prevent bias. At the conclusion of the patient's involvement&#xD;
      in the study they will be informed that their data has been collected and will have the&#xD;
      opportunity to opt out of the study, at which time the collected data will be destroyed.&#xD;
&#xD;
      Postoperatively the surgical team will ask the patient to provide a pain score during morning&#xD;
      rounds as part of routine care. The pain score will be recorded by a member of the surgical&#xD;
      team. Within 60 minutes of their rounds and prior to any pain inducing events (such as&#xD;
      physical therapy or repositioning), the surgical team will ask the nurse caring for the&#xD;
      patient to enter the room by his/her self and ask the patient the same routine questions&#xD;
      including the pain score. The nurse will record the pain score. No member of the surgical&#xD;
      team will enter the room while the nurse is present in order to prevent bias. This process&#xD;
      will be repeated once a day up to three days for each patient after the patient's operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>3 days</time_frame>
    <description>Pain scores will be compared between those reported by the patient to the nurse and physician to evaluate for consistency. The visual analog scale (VAS) ranges from a minimum score of 0 representing &quot;no pain at all&quot; and a maximum score of 10 which represents &quot;worst pain imaginable&quot;. The VAS is represented as a 100 mm horizontal line in increments of 10mm. Subjects indicate their pain level on the scale.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <condition>Pain Control</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Postoperative</arm_group_label>
    <description>The study will evaluate orthopedic postoperative patients during the hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative</intervention_name>
    <description>No intervention is planned in the study. This study is simply evaluating the consistency with which patients report their pain levels to different members of the medical team.</description>
    <arm_group_label>Postoperative</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all postoperative orthopedic patients during the&#xD;
        hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All inpatient postoperative orthopedic patients will be eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If a patient is unwilling to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Wilke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Benjamin K. Wilke</investigator_full_name>
    <investigator_title>Assistant Professor of Orthopedics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <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/NCT03840356
org study id: 18-004244
nct id: NCT03840356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effective pain control following surgical procedures is a goal for both the patient as well
      as the medical staff caring for them. There have been numerous studies evaluating differing
      treatment pathways, but most studies have relied on the Visual Analog Scale (VAS) or
      Numerical Rating Scale (NRS) to evaluate outcomes. These scales are subjective score given by
      the patient with no objective data input, therefore making comparisons subject to possible
      bias. There are no known studies comparing the pain scores provided by the patient to the
      surgical team compared to the nursing staff caring for the patient. The aim will be to
      compare these values to see if patients are consistent in their pain rating.
The project will be conducted as a prospective study comparing numerical rating scale pain
      scores reported by the patients to the surgical team and the nursing staff. All orthopedic
      inpatients will be eligible for the study. Subjects will not be consented for the study prior
      to data collection in order to prevent bias. At the conclusion of the patient's involvement
      in the study they will be informed that their data has been collected and will have the
      opportunity to opt out of the study, at which time the collected data will be destroyed.

      Postoperatively the surgical team will ask the patient to provide a pain score during morning
      rounds as part of routine care. The pain score will be recorded by a member of the surgical
      team. Within 60 minutes of their rounds and prior to any pain inducing events (such as
      physical therapy or repositioning), the surgical team will ask the nurse caring for the
      patient to enter the room by his/her self and ask the patient the same routine questions
      including the pain score. The nurse will record the pain score. No member of the surgical
      team will enter the room while the nurse is present in order to prevent bias. This process
      will be repeated once a day up to three days for each patient after the patient's operation.
observational model: Cohort
time perspective: Prospective
measure: Pain score
time frame: 3 days
description: Pain scores will be compared between those reported by the patient to the nurse and physician to evaluate for consistency. The visual analog scale (VAS) ranges from a minimum score of 0 representing "no pain at all" and a maximum score of 10 which represents "worst pain imaginable". The VAS is represented as a 100 mm horizontal line in increments of 10mm. Subjects indicate their pain level on the scale.
arm group label: Postoperative
description: The study will evaluate orthopedic postoperative patients during the hospitalization.
intervention type: Other
intervention name: Postoperative
description: No intervention is planned in the study. This study is simply evaluating the consistency with which patients report their pain levels to different members of the medical team.
arm group label: Postoperative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Benjamin Wilke, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Benjamin K. Wilke
investigator title: Assistant Professor of Orthopedics
mesh term: Pain, Postoperative
sharing ipd: Undecided