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/NCT06014918</url>
    </required_header>
    <id_info>
      <org_study_id>2304-053-1420</org_study_id>
      <nct_id>NCT06014918</nct_id>
    </id_info>
    <brief_title>App for Acute Pain Service in Major Surgery</brief_title>
    <official_title>A Smart Device Application for Acute Pain Service in Patients Undergoing Major Surgery: A Prospective Observational Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National 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>
        The app will be installed on the patient's smartphone before surgery. Patients will receive&#xD;
        reminders to record their pain intensity and opioid-related side effects at the&#xD;
        pre-determined time points until at least 2 days after surgery. The patient's compliance with&#xD;
        the reminders will be assessed. On the second postoperative day, their satisfaction with pain&#xD;
        control and app usage will be evaluated. Patients can also provide feedback on any issues&#xD;
        they have encountered with the app during the study period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Following admission, the application will be installed on the enrolled patient's smartphone&#xD;
        prior to surgery, and the patient will be instructed on the content of the program and how to&#xD;
        use it. Educational videos within the app about postoperative pain control will be introduced&#xD;
        to the patient at this time. At the pre-determined time points, until at least 2 days&#xD;
        post-operatively, the patient will be reminded of the assessment via an alarm function and&#xD;
        will enter post-operative pain intensity using an 11-point numeric rating scale or verbal&#xD;
        rating scale and the presence of opioid-related side effects into the application. If a&#xD;
        patient responds to the alarm 2 or more times per day, they will be considered to be&#xD;
        compliant. Postoperative opioid consumption using patient-controlled analgesia and the amount&#xD;
        of rescue analgesics will be assessed. Patients will be assessed with a survey on&#xD;
        postoperative day 2 for overall satisfaction with pain control and usage of the application.&#xD;
        Patients will also be able to provide feedback via the application or research staff on any&#xD;
        errors or inconveniences they may have experienced while using the application throughout the&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This study is designed to examine the feasibility of a smart device application to assess and manage postoperative pain in a single group of patients undergoing major surgery.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>As this is an observational study to assess feasibility, the participants, care providers, researchers, and outcome assessors cannot be masked by the nature of the design.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patients' adherence rate to Smart APS</measure>
      <time_frame>Postoperative day 1 and 2</time_frame>
      <description>Proportion of patients who successfully used the smart APS among all patients.. Through Smart APS, a self-assessment is conducted three times a day, and it is assumed that the application has been used successfully if the patient completes an evaluation of pain intensity and opioid analgesic side effects at least twice on the first and second days after surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction with pain management</measure>
      <time_frame>Postoperative day 2</time_frame>
      <description>Patient satisfaction with pain management using the 'Smart APS' app, rated on an 11-point scale (0 to 10 points, a higher number indicates higher satisfaction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction with application usage</measure>
      <time_frame>Postoperative day 2</time_frame>
      <description>A survey of patient satisfaction with the use of the 'Smart APS' app, consisted of 6 questions which are rated on a 7-point scale.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of spontaneous assessments</measure>
      <time_frame>Whole study period (from the day of surgery to at least 2 days after surgery)</time_frame>
      <description>The number of spontaneous assessments made by the participant outside of the scheduled assessment time.</description>
    </other_outcome>
    <other_outcome>
      <measure>Amount of analgesics used</measure>
      <time_frame>Whole study period (from the day of surgery to at least 2 days after surgery)</time_frame>
      <description>Total volume of patient-controlled analgesia used and rescue analgesics.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient satisfaction with the provided audio-visual educational materials</measure>
      <time_frame>Postoperative day 2</time_frame>
      <description>Patient satisfaction with the provided four audio-visual materials is evaluated on a 0-10 scale. (A higher score indicates higher satisfaction)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Mobile Applications</condition>
    <condition>Pain, Postoperative</condition>
    <condition>Smartphone</condition>
    <condition>Patient Satisfaction</condition>
    <arm_group>
      <arm_group_label>Patients using a new application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will enter pain intensity and opioid analgesic side effects using a new application named 'Smart APS', developed for acute pain services, and later assess for adherence and satisfaction with the application use.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>A new smart device application (Smart APS)</intervention_name>
      <description>The application sends alarms to patients to enter their pain intensity and opioid-related side effects at the times set by the researcher. Additional entries for severe pain or opioid side effects are also available at any other time. Researchers can monitor the results in real-time via an integrated web program. If a red flag sign is observed during regular office hours, an anesthesiologist participating in the research will visit the patient for assessment and intervention. In addition, patients can watch pre-made perioperative pain-related educational videos through the smart APS.</description>
      <arm_group_label>Patients using a new application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 19 to 70 years who are scheduled for regular major surgery&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status classification I or II&#xD;
  &#xD;
            -  Patients who are using a smartphone and are not expected to have any restrictions on&#xD;
               application use&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to communicate&#xD;
  &#xD;
            -  Patients under the age of 19 and over the age of 70&#xD;
  &#xD;
            -  Patients who, in the opinion of the investigator or study staff, are not appropriate&#xD;
               for this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hojin Lee, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hojin Lee, PhD</last_name>
      <phone>82-2-2072-2467</phone>
      <email>hjpainfree@snu.ac.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Soohyuk Yoon, MD</last_name>
      <phone>82-2-2072-1645</phone>
      <email>yoonsh3152@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>KS013</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hojin Lee, MD, PhD</last_name>
        <phone>82-2-2072-2467</phone>
        <email>zenerdiode03@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Hojin Lee, MD</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <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/NCT06014918
  org study id: 2304-053-1420
  nct id: NCT06014918
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The app will be installed on the patient's smartphone before surgery. Patients will receive
        reminders to record their pain intensity and opioid-related side effects at the
        pre-determined time points until at least 2 days after surgery. The patient's compliance with
        the reminders will be assessed. On the second postoperative day, their satisfaction with pain
        control and app usage will be evaluated. Patients can also provide feedback on any issues
        they have encountered with the app during the study period.
  Following admission, the application will be installed on the enrolled patient's smartphone
        prior to surgery, and the patient will be instructed on the content of the program and how to
        use it. Educational videos within the app about postoperative pain control will be introduced
        to the patient at this time. At the pre-determined time points, until at least 2 days
        post-operatively, the patient will be reminded of the assessment via an alarm function and
        will enter post-operative pain intensity using an 11-point numeric rating scale or verbal
        rating scale and the presence of opioid-related side effects into the application. If a
        patient responds to the alarm 2 or more times per day, they will be considered to be
        compliant. Postoperative opioid consumption using patient-controlled analgesia and the amount
        of rescue analgesics will be assessed. Patients will be assessed with a survey on
        postoperative day 2 for overall satisfaction with pain control and usage of the application.
        Patients will also be able to provide feedback via the application or research staff on any
        errors or inconveniences they may have experienced while using the application throughout the
        study.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This study is designed to examine the feasibility of a smart device application to assess and manage postoperative pain in a single group of patients undergoing major surgery.
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: As this is an observational study to assess feasibility, the participants, care providers, researchers, and outcome assessors cannot be masked by the nature of the design.
  measure: Patients' adherence rate to Smart APS
  time frame: Postoperative day 1 and 2
  description: Proportion of patients who successfully used the smart APS among all patients.. Through Smart APS, a self-assessment is conducted three times a day, and it is assumed that the application has been used successfully if the patient completes an evaluation of pain intensity and opioid analgesic side effects at least twice on the first and second days after surgery.
  measure: Patient satisfaction with pain management
  time frame: Postoperative day 2
  description: Patient satisfaction with pain management using the 'Smart APS' app, rated on an 11-point scale (0 to 10 points, a higher number indicates higher satisfaction).
  measure: Patient satisfaction with application usage
  time frame: Postoperative day 2
  description: A survey of patient satisfaction with the use of the 'Smart APS' app, consisted of 6 questions which are rated on a 7-point scale.
  measure: Number of spontaneous assessments
  time frame: Whole study period (from the day of surgery to at least 2 days after surgery)
  description: The number of spontaneous assessments made by the participant outside of the scheduled assessment time.
  measure: Amount of analgesics used
  time frame: Whole study period (from the day of surgery to at least 2 days after surgery)
  description: Total volume of patient-controlled analgesia used and rescue analgesics.
  measure: Patient satisfaction with the provided audio-visual educational materials
  time frame: Postoperative day 2
  description: Patient satisfaction with the provided four audio-visual materials is evaluated on a 0-10 scale. (A higher score indicates higher satisfaction)
  arm group label: Patients using a new application
  arm group type: Experimental
  description: Patients will enter pain intensity and opioid analgesic side effects using a new application named 'Smart APS', developed for acute pain services, and later assess for adherence and satisfaction with the application use.
  intervention type: Device
  intervention name: A new smart device application (Smart APS)
  description: The application sends alarms to patients to enter their pain intensity and opioid-related side effects at the times set by the researcher. Additional entries for severe pain or opioid side effects are also available at any other time. Researchers can monitor the results in real-time via an integrated web program. If a red flag sign is observed during regular office hours, an anesthesiologist participating in the research will visit the patient for assessment and intervention. In addition, patients can watch pre-made perioperative pain-related educational videos through the smart APS.
  arm group label: Patients using a new application
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Hojin Lee, PhD
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Hojin Lee, PhD
  phone: 82-2-2072-2467
  email: hjpainfree@snu.ac.kr
  last name: Soohyuk Yoon, MD
  phone: 82-2-2072-1645
  email: yoonsh3152@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Hojin Lee, MD
  investigator title: Associate professor
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  sharing ipd: No