<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/NCT03238976</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-0355</org_study_id>
    <nct_id>NCT03238976</nct_id>
  </id_info>
  <brief_title>Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy</brief_title>
  <official_title>Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy: A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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>
      Patients will be randomly assigned to one of two groups: the group exposed to NS, or the&#xD;
      standard care group exposed to supportive dialogue. Patients assigned to the former group&#xD;
      will be exposed to continuous NS throughout the CNB procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5&#xD;
      min biopsy planning period during which only imaging occurs after patient positioning and&#xD;
      breast compression is complete, (2) One 2-min local anesthesia administration period during&#xD;
      which the skin is injected with local anesthetic and an incision is made to insert the biopsy&#xD;
      needle into the breast occurs (&quot;stressor 1&quot;), (3) One 2-minute post local anesthesia&#xD;
      administration period during which imaging is obtained to confirm the position of the needle&#xD;
      with respect to the target, (4) One 1-minute sampling period when the breast tissue is&#xD;
      sampled ('stressor 2&quot;), (5) One 2-minute post-CNB period, during which adequacy of obtained&#xD;
      samples is confirmed and the need for additional sampling determined, and (6) One 2-minute&#xD;
      period during which a biopsy marker clip is deployed and pressure dressing placed on the&#xD;
      biopsy site.&#xD;
&#xD;
      For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline&#xD;
      5 min biopsy planning period during which only imaging occurs after patient is positioning,&#xD;
      (2) One 2-min local anesthesia administration period during which local anesthesia is given&#xD;
      at the site of biopsy and a skin incision performed (&quot;stressor 1&quot;), (3) One post local&#xD;
      anesthesia administration period during which intra-procedure imaging and confirmation of&#xD;
      adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2&quot;) during&#xD;
      which the biopsy device is advanced to the target for the first time and fired to acquire the&#xD;
      first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass&#xD;
      while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6)&#xD;
      One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure&#xD;
      dressing placed on the biopsy site.&#xD;
&#xD;
      The total time for a single site CNB is approximately 30 minutes when performed under&#xD;
      US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added&#xD;
      physiological recordings for this experiment are not expected to significantly prolong the&#xD;
      duration of CNB procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of psychologic stress of patients and staff</measure>
    <time_frame>From the start of procedure until the end, not to exceed 2 years.</time_frame>
    <description>Patients and staff will be required to complete a questionnaire. Questions are organized so to capture levels of psychologic stress. The answers will be compared across the two groups and descriptive statistics will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of physiologic stress of patients and staff</measure>
    <time_frame>From the start of procedure until the end, not to exceed 2 years.</time_frame>
    <description>Parasympathetic activity will be measured by HF HRV in patients and staff. Descriptive statistics from these measurements will be calculated and compared across the two groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Nature sounds exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomly assigned to either the nature sounds group or the standard care group.&#xD;
Patients in the nature sounds group will be exposed to continuous nature sounds during the core needle biopsy (CNB) procedure.&#xD;
The CNB procedure will continue as planned with nature sounds playing instead of the supportive dialogue. All sounds will be played out of a speaker situated in the corner of the room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care (supportive dialogue)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be randomly assigned to either the nature sounds group or the standard care group.&#xD;
The CNB procedure will continue as planned with supportive dialogue which will be played out of a speaker situated in the corner of the room. This group follows the current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nature sounds</intervention_name>
    <description>Nature sounds will be played for patients in the nature sounds exposure group.</description>
    <arm_group_label>Nature sounds exposure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) ≥ 21 years old&#xD;
&#xD;
          -  2) present for CNB&#xD;
&#xD;
          -  3) to be able to read and speak English&#xD;
&#xD;
          -  4) provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirti Kulkarni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cancer Clinical Trials Office</last_name>
    <phone>1-855-702-8222</phone>
    <email>cancerclinicaltrials@bsd.uchicago.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirti Kulkarni, MD</last_name>
      <phone>773-702-1559</phone>
      <email>kirti.kulkarni@uchospitals.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast core biopsy</keyword>
  <keyword>core needle biopsies</keyword>
  <!-- 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/NCT03238976
org study id: IRB17-0355
nct id: NCT03238976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients will be randomly assigned to one of two groups: the group exposed to NS, or the
      standard care group exposed to supportive dialogue. Patients assigned to the former group
      will be exposed to continuous NS throughout the CNB procedure.
For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5
      min biopsy planning period during which only imaging occurs after patient positioning and
      breast compression is complete, (2) One 2-min local anesthesia administration period during
      which the skin is injected with local anesthetic and an incision is made to insert the biopsy
      needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia
      administration period during which imaging is obtained to confirm the position of the needle
      with respect to the target, (4) One 1-minute sampling period when the breast tissue is
      sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained
      samples is confirmed and the need for additional sampling determined, and (6) One 2-minute
      period during which a biopsy marker clip is deployed and pressure dressing placed on the
      biopsy site.

      For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline
      5 min biopsy planning period during which only imaging occurs after patient is positioning,
      (2) One 2-min local anesthesia administration period during which local anesthesia is given
      at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local
      anesthesia administration period during which intra-procedure imaging and confirmation of
      adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during
      which the biopsy device is advanced to the target for the first time and fired to acquire the
      first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass
      while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6)
      One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure
      dressing placed on the biopsy site.

      The total time for a single site CNB is approximately 30 minutes when performed under
      US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added
      physiological recordings for this experiment are not expected to significantly prolong the
      duration of CNB procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Measure of psychologic stress of patients and staff
time frame: From the start of procedure until the end, not to exceed 2 years.
description: Patients and staff will be required to complete a questionnaire. Questions are organized so to capture levels of psychologic stress. The answers will be compared across the two groups and descriptive statistics will be calculated.
measure: Measure of physiologic stress of patients and staff
time frame: From the start of procedure until the end, not to exceed 2 years.
description: Parasympathetic activity will be measured by HF HRV in patients and staff. Descriptive statistics from these measurements will be calculated and compared across the two groups.
arm group label: Nature sounds exposure
arm group type: Experimental
description: Patients will be randomly assigned to either the nature sounds group or the standard care group.
Patients in the nature sounds group will be exposed to continuous nature sounds during the core needle biopsy (CNB) procedure.
The CNB procedure will continue as planned with nature sounds playing instead of the supportive dialogue. All sounds will be played out of a speaker situated in the corner of the room.
arm group label: Standard care (supportive dialogue)
arm group type: No Intervention
description: Patients will be randomly assigned to either the nature sounds group or the standard care group.
The CNB procedure will continue as planned with supportive dialogue which will be played out of a speaker situated in the corner of the room. This group follows the current standard of care.
intervention type: Other
intervention name: Nature sounds
description: Nature sounds will be played for patients in the nature sounds exposure group.
arm group label: Nature sounds exposure
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Kirti Kulkarni, MD
role: Principal Investigator
affiliation: University of Chicago
last name: Cancer Clinical Trials Office
phone: 1-855-702-8222
email: cancerclinicaltrials@bsd.uchicago.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor