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/NCT05980247</url>
    </required_header>
    <id_info>
      <org_study_id>CHLA-23-00176</org_study_id>
      <nct_id>NCT05980247</nct_id>
    </id_info>
    <brief_title>Thimble Mindfulness App and Recovery Patch Descriptions</brief_title>
    <official_title>Using a Mindfulness-Based App and Plant-Based Recovery Patch to Reduce Pain and Anxiety of Needles in the Pediatric Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bianca Edison</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Thimble Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital Los Angeles</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to lessen the pain and fear of needles by using a&#xD;
        mindfulness-based app and a recovery patch on pediatric patients between the ages of 5 and&#xD;
        11. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can guided mindfulness practices lessen the fear of needles experienced among pediatric&#xD;
             patients?&#xD;
  &#xD;
          -  Can a recovery patch with natural ingredients lessen the pain derived from needle-based&#xD;
             procedures when placed on the site of the needle wound?&#xD;
  &#xD;
        Participants will be asked to be part of a clinical trial in which they will be picked to be&#xD;
        in one of four groups: control (no use of the patch or app), use of Thimble Mindfulness App&#xD;
        only (Experimental- App), use of Thimble Recovery Patch only (Experimental-Patch), or use of&#xD;
        both Thimble Mindfulness App and Recovery Patch (Experimental-Patch and App). Patients will&#xD;
        be asked to:&#xD;
  &#xD;
          -  Complete a survey at enrollment (demographics + State-Trait Anxiety Inventory for&#xD;
             Children (STAI-C))&#xD;
  &#xD;
          -  If the experimental group with the app, they will use the app before, during, and after&#xD;
             their needle-based procedure.&#xD;
  &#xD;
          -  Complete another survey immediately before needle procedure (STAI-C survey)&#xD;
  &#xD;
          -  If in experimental group with the patch, they will allow the doctor or nurse to apply&#xD;
             the Recovery Patch on the site of the needle wound.&#xD;
  &#xD;
          -  Complete a survey immediately after needle procedure (STAI-C survey) and app/patch&#xD;
             feedback (if assigned to app and/or patch group)&#xD;
  &#xD;
          -  Complete another survey 24-48 hours after needle procedure (STAI-C survey) and app/patch&#xD;
             feedback (if assigned to app and/or patch group) Researchers will compare the 4 groups&#xD;
             to see if these interventions (alone or together) improve anxiety and pain associated&#xD;
             with needle-based procedures within the pediatric population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  This study aims to provide patients with a tool to reduce needle anxiety and establish&#xD;
             healthy coping habits when addressing and managing fear. In addition, we will examine&#xD;
             the utility of a plant-based post procedure patch in lessening the pain and anxiety that&#xD;
             may stem from needle procedures.&#xD;
  &#xD;
          -  Patients between the ages of 5 and 11 undergoing needle-based procedures will be invited&#xD;
             to participate. Patients will be randomized into one of four groups: control (no&#xD;
             intervention), intervention (app), intervention (patch), or intervention (app+patch).&#xD;
             Children and their caregivers will fill out a secure, online-based survey that includes&#xD;
             a demographics (age, gender, ethnicity, zip code) and validated anxiety measure tool&#xD;
             S-STAI. They will then, those who are randomized to the groups using the app will scan a&#xD;
             QR code to quickly access the web-based app on their mobile device or through a&#xD;
             clinic-owned iPad. They will be able to interact with the app as desired;&#xD;
             before/during/after the needle-based procedure.&#xD;
  &#xD;
          -  The app opens with a note of validation presented by an inclusive character and then&#xD;
             allows the user to choose where they are in the appointment process: Is it coming up, is&#xD;
             it right now, or is it all done? In the preparation section one finds informative&#xD;
             animations about how to prepare for needle procedures. Here, clear, honest language is&#xD;
             utilized to calmly inform the child of what will take place so that expectations are&#xD;
             managed. We encourage the child to choose an ideal comfort position and discuss their&#xD;
             needs with the caregiver. This section can be used in the days, hours, or minutes&#xD;
             leading up to the visit.&#xD;
  &#xD;
          -  Next, the platform offers steps to take during the visit. There are three steps outlined&#xD;
             but the user can choose any module at any time. Steps 1 and 2 include exercises with&#xD;
             engaging animations that utilize applied muscle tension techniques and breathing&#xD;
             techniques to help relax the child. Step 3 includes an interactive short, winnable game,&#xD;
             which is best used during the procedure to distract the child from the needle.&#xD;
  &#xD;
          -  Once the procedure is done, the user clicks on the after section where we celebrate and&#xD;
             affirm the child's accomplishment. We encourage caregivers to share this proud moment&#xD;
             with their friends and family, with the hopes of creating some virality in this&#xD;
             movement. The &quot;After&quot; section is a combination of positive reinforcement, a chance to&#xD;
             reflect on the experience, and eventually sharing success on social media.&#xD;
  &#xD;
          -  The post-intervention surveys will ask participants if they would be willing/interested&#xD;
             in a short-semi-structured interview. If patients express interest, they will set up a&#xD;
             virtual interview time/date with the research team to meet with Dr. Dawkins and Dr.&#xD;
             Edison.&#xD;
  &#xD;
          -  The Recover Patch contains Arnica montana(14%), Curcuma longa (turmeric) (8.1%), Piper&#xD;
             nigrum (black pepper)(1.0%), CoQ10 (0.3%), and acrylic adhesive (76%). The Thimble patch&#xD;
             will be placed on the site of the needle procedure for those who are placed in the&#xD;
             intervention arms that include the Thimble patch. Patients who receive the patch will be&#xD;
             instructed to wear the patch for 8-48 hours total.&#xD;
  &#xD;
          -  After the use of the app and after their needle-based procedure, they will fill out the&#xD;
             validated anxiety measurement tool again for post-comparison. They will also be asked to&#xD;
             undergo an optional short semi-structured interview.&#xD;
  &#xD;
          -  The healthcare staff involved in providing the needle-based procedure will also be given&#xD;
             a survey to complete to provide their feedback on the effectiveness of the app and how&#xD;
             it impacted the appointment overall.&#xD;
  &#xD;
          -  Participants will also provide their email to which the post-procedure survey will be&#xD;
             sent 24 hours after their visit. This survey aims to gather their thoughts of the clinic&#xD;
             visit/app and/or patch the day after their needle procedure while also measuring their&#xD;
             anxiety and pain levels.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 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>One control group and three intervention groups.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Scores from the State Trait Anxiety Inventory for Children (STAI-C)</measure>
      <time_frame>Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure</time_frame>
      <description>Measures anxiety in children. Children respond to the STAI-C by selecting one of three choices for each item that best represents how they feel. Each STAI-C item is measured on a 3-point rating scale for which each response is assigned values of either 1, 2, or 3. Scores on the STAI-C range from a minimum of 20 to a maximum of 60. Higher scores indicate greater levels of anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceived Swelling</measure>
      <time_frame>24-48 hours after needle-based procedure</time_frame>
      <description>Patients and/or parents will describe whether or not they felt the patch helped provide some relief from swelling in feedback survey</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Needle Fear</condition>
    <condition>Vaccine Hesitancy</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No application and no thimble patch.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Use of the thimble application but not the thimble patch</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of the thimble application but not the thimble patch</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Use of the thimble patch but not the thimble application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of the thimble patch but not the thimble application</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Use of both thimble application and thimble patch</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of both thimble application and thimble patch</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Thimble Application</intervention_name>
      <description>Use of of thimble application to practice mindfulness before needle procedure.</description>
      <arm_group_label>Use of both thimble application and thimble patch</arm_group_label>
      <arm_group_label>Use of the thimble application but not the thimble patch</arm_group_label>
      <arm_group_label>Use of the thimble patch but not the thimble application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients between the ages of 5 and 11 undergoing a needle-based procedure. (eg.&#xD;
               vaccination administration, medication administration, blood draws)&#xD;
  &#xD;
            -  Parents over the age of 18 years.&#xD;
  &#xD;
            -  Patients with the cognitive ability to use and navigate the app.&#xD;
  &#xD;
            -  Patients with non-complex outpatient procedures&#xD;
  &#xD;
            -  English-speaking patients&#xD;
  &#xD;
            -  Healthcare staff performing needle-based procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under the age of 5 or older than 12. Patients who are not undergoing a&#xD;
               needle-based procedure.&#xD;
  &#xD;
            -  Pregnant women, prisoners, and adults unable to consent will not be included in this&#xD;
               study.&#xD;
  &#xD;
            -  Patients lacking the cognitive ability to use and navigate the app&#xD;
  &#xD;
            -  Patients undergoing needle-based procedure as part of a more complex or inpatient&#xD;
               procedure.&#xD;
  &#xD;
            -  Patients speaking any other language other than English.&#xD;
  &#xD;
            -  Healthcare staff other than those performing the needle-based procedures.&#xD;
  &#xD;
            -  Patients who report an allergy to any of the ingredients listed in the Thimble&#xD;
               Recovery Patch&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bianca Edison, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Hospital Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacquelyn Valenzuela-Moss, BS</last_name>
      <phone>(323) 660-2450</phone>
      <phone_ext>17579</phone_ext>
      <email>jvalmoss@chla.usc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tishya Wren, PhD</last_name>
      <phone>(323) 361-4335</phone>
      <email>twren@chla.usc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital Los Angeles</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90027</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
      <investigator_full_name>Bianca Edison</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Thimble Recovery Patch</keyword>
    <keyword>Thimble Mindfulness Application</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/NCT05980247
  org study id: CHLA-23-00176
  nct id: NCT05980247
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The goal of this clinical trial is to lessen the pain and fear of needles by using a
        mindfulness-based app and a recovery patch on pediatric patients between the ages of 5 and
        11. The main questions it aims to answer are:
  
          -  Can guided mindfulness practices lessen the fear of needles experienced among pediatric
             patients?
  
          -  Can a recovery patch with natural ingredients lessen the pain derived from needle-based
             procedures when placed on the site of the needle wound?
  
        Participants will be asked to be part of a clinical trial in which they will be picked to be
        in one of four groups: control (no use of the patch or app), use of Thimble Mindfulness App
        only (Experimental- App), use of Thimble Recovery Patch only (Experimental-Patch), or use of
        both Thimble Mindfulness App and Recovery Patch (Experimental-Patch and App). Patients will
        be asked to:
  
          -  Complete a survey at enrollment (demographics + State-Trait Anxiety Inventory for
             Children (STAI-C))
  
          -  If the experimental group with the app, they will use the app before, during, and after
             their needle-based procedure.
  
          -  Complete another survey immediately before needle procedure (STAI-C survey)
  
          -  If in experimental group with the patch, they will allow the doctor or nurse to apply
             the Recovery Patch on the site of the needle wound.
  
          -  Complete a survey immediately after needle procedure (STAI-C survey) and app/patch
             feedback (if assigned to app and/or patch group)
  
          -  Complete another survey 24-48 hours after needle procedure (STAI-C survey) and app/patch
             feedback (if assigned to app and/or patch group) Researchers will compare the 4 groups
             to see if these interventions (alone or together) improve anxiety and pain associated
             with needle-based procedures within the pediatric population.
  -  This study aims to provide patients with a tool to reduce needle anxiety and establish
             healthy coping habits when addressing and managing fear. In addition, we will examine
             the utility of a plant-based post procedure patch in lessening the pain and anxiety that
             may stem from needle procedures.
  
          -  Patients between the ages of 5 and 11 undergoing needle-based procedures will be invited
             to participate. Patients will be randomized into one of four groups: control (no
             intervention), intervention (app), intervention (patch), or intervention (app+patch).
             Children and their caregivers will fill out a secure, online-based survey that includes
             a demographics (age, gender, ethnicity, zip code) and validated anxiety measure tool
             S-STAI. They will then, those who are randomized to the groups using the app will scan a
             QR code to quickly access the web-based app on their mobile device or through a
             clinic-owned iPad. They will be able to interact with the app as desired;
             before/during/after the needle-based procedure.
  
          -  The app opens with a note of validation presented by an inclusive character and then
             allows the user to choose where they are in the appointment process: Is it coming up, is
             it right now, or is it all done? In the preparation section one finds informative
             animations about how to prepare for needle procedures. Here, clear, honest language is
             utilized to calmly inform the child of what will take place so that expectations are
             managed. We encourage the child to choose an ideal comfort position and discuss their
             needs with the caregiver. This section can be used in the days, hours, or minutes
             leading up to the visit.
  
          -  Next, the platform offers steps to take during the visit. There are three steps outlined
             but the user can choose any module at any time. Steps 1 and 2 include exercises with
             engaging animations that utilize applied muscle tension techniques and breathing
             techniques to help relax the child. Step 3 includes an interactive short, winnable game,
             which is best used during the procedure to distract the child from the needle.
  
          -  Once the procedure is done, the user clicks on the after section where we celebrate and
             affirm the child's accomplishment. We encourage caregivers to share this proud moment
             with their friends and family, with the hopes of creating some virality in this
             movement. The "After" section is a combination of positive reinforcement, a chance to
             reflect on the experience, and eventually sharing success on social media.
  
          -  The post-intervention surveys will ask participants if they would be willing/interested
             in a short-semi-structured interview. If patients express interest, they will set up a
             virtual interview time/date with the research team to meet with Dr. Dawkins and Dr.
             Edison.
  
          -  The Recover Patch contains Arnica montana(14%), Curcuma longa (turmeric) (8.1%), Piper
             nigrum (black pepper)(1.0%), CoQ10 (0.3%), and acrylic adhesive (76%). The Thimble patch
             will be placed on the site of the needle procedure for those who are placed in the
             intervention arms that include the Thimble patch. Patients who receive the patch will be
             instructed to wear the patch for 8-48 hours total.
  
          -  After the use of the app and after their needle-based procedure, they will fill out the
             validated anxiety measurement tool again for post-comparison. They will also be asked to
             undergo an optional short semi-structured interview.
  
          -  The healthcare staff involved in providing the needle-based procedure will also be given
             a survey to complete to provide their feedback on the effectiveness of the app and how
             it impacted the appointment overall.
  
          -  Participants will also provide their email to which the post-procedure survey will be
             sent 24 hours after their visit. This survey aims to gather their thoughts of the clinic
             visit/app and/or patch the day after their needle procedure while also measuring their
             anxiety and pain levels.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: One control group and three intervention groups.
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Scores from the State Trait Anxiety Inventory for Children (STAI-C)
  time frame: Measured upon enrollment, immediately before needle-based procedure, immediately after needle-based procedure and 24-48 hours after procedure
  description: Measures anxiety in children. Children respond to the STAI-C by selecting one of three choices for each item that best represents how they feel. Each STAI-C item is measured on a 3-point rating scale for which each response is assigned values of either 1, 2, or 3. Scores on the STAI-C range from a minimum of 20 to a maximum of 60. Higher scores indicate greater levels of anxiety.
  measure: Perceived Swelling
  time frame: 24-48 hours after needle-based procedure
  description: Patients and/or parents will describe whether or not they felt the patch helped provide some relief from swelling in feedback survey
  arm group label: Control
  arm group type: No Intervention
  description: No application and no thimble patch.
  arm group label: Use of the thimble application but not the thimble patch
  arm group type: Experimental
  description: Use of the thimble application but not the thimble patch
  arm group label: Use of the thimble patch but not the thimble application
  arm group type: Experimental
  description: Use of the thimble patch but not the thimble application
  arm group label: Use of both thimble application and thimble patch
  arm group type: Experimental
  description: Use of both thimble application and thimble patch
  intervention type: Device
  intervention name: Thimble Application
  description: Use of of thimble application to practice mindfulness before needle procedure.
  arm group label: Use of both thimble application and thimble patch
  arm group label: Use of the thimble application but not the thimble patch
  arm group label: Use of the thimble patch but not the thimble application
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 11 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bianca Edison, MD
  role: Principal Investigator
  affiliation: Children's Hospital Los Angeles
  last name: Jacquelyn Valenzuela-Moss, BS
  phone: (323) 660-2450
  phone ext: 17579
  email: jvalmoss@chla.usc.edu
  last name: Tishya Wren, PhD
  phone: (323) 361-4335
  email: twren@chla.usc.edu
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Children's Hospital Los Angeles
  investigator full name: Bianca Edison
  investigator title: Principal Investigator
  sharing ipd: No