<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/NCT03023215</url>
  </required_header>
  <id_info>
    <org_study_id>2011-1094</org_study_id>
    <secondary_id>NCI-2017-00506</secondary_id>
    <nct_id>NCT03023215</nct_id>
  </id_info>
  <brief_title>Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy</brief_title>
  <official_title>Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      The goal of this behavioral research study is to learn if taking part in guided relaxation&#xD;
      programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will&#xD;
      also examine whether the guided relaxation programs change brain activity, heart rate, and&#xD;
      blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline Data Collection:&#xD;
&#xD;
      If participant chooses to take part in this study, they will be asked to fill out several&#xD;
      questionnaires on an MD Anderson computer. Participant will be asked questions about anxiety,&#xD;
      pain, and spirituality. The questionnaires will take about 20 minutes to complete.&#xD;
&#xD;
      Participant will have their heart rate and blood pressure taken, which will take about 3&#xD;
      minutes to complete. Participant will then have an electroencephalogram (EEG) done. An EEG is&#xD;
      used to view a person's brain waves. The EEG should take about 5 minutes to complete. During&#xD;
      the EEG, a snug cap which contains small electrodes will be placed on the head to measure the&#xD;
      electrical patterns coming from the brain--much like the way a doctor listens to&#xD;
      participant's heart from the surface of their skin. The EEG cap will stay on participant's&#xD;
      head until the end of the study.&#xD;
&#xD;
      Study Groups:&#xD;
&#xD;
      After the baseline information is collected, participant will be randomly assigned (as in the&#xD;
      role of a die) to 1 of 3 study groups: 2 relaxation training groups or a standard care group.&#xD;
      Based on the way the study is designed, there is a 1 in 5 (or 20%) chance that participant&#xD;
      will be assigned to the standard care group, and a 4 in 5 (or 80%) chance that participant&#xD;
      will be assigned to one of the relaxation groups. Both relaxation groups will focus on&#xD;
      helping participant to relax by focusing on their breath. At the end of participation, all&#xD;
      groups will be given a 25 minute relaxation audio CD created by the MD Anderson Integrative&#xD;
      Medicine Program.&#xD;
&#xD;
      Pre-Breast Biopsy Procedures:&#xD;
&#xD;
      Participants assigned to the relaxation groups will be guided through relaxation techniques&#xD;
      for 10 minutes before the biopsy. Participants assigned to the third group will listen to 10&#xD;
      minutes of National Public Radio.&#xD;
&#xD;
      Participant's heart rate and EEG activity will be recorded during this 10-minute period of&#xD;
      time. At the end of the 10-minute period before the breast biopsy, participant's blood&#xD;
      pressure will be taken again and they will complete a 5 minute questionnaire about anxiety.&#xD;
&#xD;
      Breast Biopsy Procedures:&#xD;
&#xD;
      When it is time for the biopsy procedure, the research assistant will go with participant to&#xD;
      their procedure room. In the procedure room, the research assistant will continue to monitor&#xD;
      participant's heart rate and EEG activity throughout the biopsy time. If participant is in&#xD;
      one of the relaxation groups, the relaxation guide will also accompany participant to the&#xD;
      procedure room and will continue to be guided through relaxation during the biopsy procedure.&#xD;
      If participant is in the standard care group, they will be provided with the usual breast&#xD;
      biopsy care. Participant will be asked to talk about any anxiety and pain at several times&#xD;
      during the procedure. Participant will also be asked to rest with their eyes closed during&#xD;
      the biopsy procedure.&#xD;
&#xD;
      After the biopsy is finished, the research assistant will go with participant to a separate&#xD;
      room, and they will have 5 minutes of EEG activity recorded, and their blood pressure will be&#xD;
      taken. The EEG cap will then be removed, and participant will be asked to complete a&#xD;
      questionnaire about their experience that will take less than 10 minutes to complete.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 85 participants will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2012</start_date>
  <completion_date type="Actual">August 10, 2022</completion_date>
  <primary_completion_date type="Actual">August 10, 2022</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)</measure>
    <time_frame>1 day</time_frame>
    <description>Trial considered successful if over 50% of eligible patients participate and at least 80% of the consented patients complete the sessions and all the measures for the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB</measure>
    <time_frame>3-5 minute intervals throughout the SBB procedure</time_frame>
    <description>Participants provide a rating from 0-10, with a rating of 0 indicating ''no anxiety'' and 10 indicating ''worst possible anxiety'' at 3-5 minute intervals throughout the SBB procedure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Meditation for Breast Biopsy</condition>
  <arm_group>
    <arm_group_label>Guided Meditation Group (GM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.&#xD;
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.&#xD;
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focused Breathing Group (FB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.&#xD;
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.&#xD;
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Group (SC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants listen to a 10 minute neutral-content audio clip from National Public Radio prior to stereotactic breast biopsy (SBB).&#xD;
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.&#xD;
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Meditation</intervention_name>
    <description>Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.</description>
    <arm_group_label>Focused Breathing Group (FB)</arm_group_label>
    <arm_group_label>Guided Meditation Group (GM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroencephalogram</intervention_name>
    <description>Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.</description>
    <arm_group_label>Focused Breathing Group (FB)</arm_group_label>
    <arm_group_label>Guided Meditation Group (GM)</arm_group_label>
    <arm_group_label>Standard of Care Group (SC)</arm_group_label>
    <other_name>EEG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.</description>
    <arm_group_label>Focused Breathing Group (FB)</arm_group_label>
    <arm_group_label>Guided Meditation Group (GM)</arm_group_label>
    <arm_group_label>Standard of Care Group (SC)</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Heart Rate</intervention_name>
    <description>Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.</description>
    <arm_group_label>Focused Breathing Group (FB)</arm_group_label>
    <arm_group_label>Guided Meditation Group (GM)</arm_group_label>
    <arm_group_label>Standard of Care Group (SC)</arm_group_label>
    <other_name>HR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women must have the ability to understand and read English, sign a written informed&#xD;
             consent, and be willing to follow protocol requirements.&#xD;
&#xD;
          2. Women must be right hand dominant.&#xD;
&#xD;
          3. Women must be 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who have a documented diagnosis of a formal thought disorder (e.g.,&#xD;
             schizophrenia) will be excluded from the study.&#xD;
&#xD;
          2. Women with a score of 3 or below on the Six-Item Cognitive Screener.&#xD;
&#xD;
          3. Women who plan to take benzodiazepine (e.g, alprazolam, diazepam, clonazepam,&#xD;
             lorazepam) or beta-blocker (e.g., propranolol, atenolol) on the day of their SBB.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorenzo Cohen, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meditation</keyword>
  <keyword>Breast Biopsy</keyword>
  <keyword>Stereotactic Breast Biopsy</keyword>
  <keyword>SBB</keyword>
  <keyword>Guided meditation</keyword>
  <keyword>Focused breathing</keyword>
  <keyword>Electroencephalogram</keyword>
  <keyword>EEG</keyword>
  <keyword>Heart rate</keyword>
  <keyword>HR</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</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/NCT03023215
org study id: 2011-1094
secondary id: NCI-2017-00506
nct id: NCT03023215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this behavioral research study is to learn if taking part in guided relaxation
      programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will
      also examine whether the guided relaxation programs change brain activity, heart rate, and
      blood pressure.
Baseline Data Collection:

      If participant chooses to take part in this study, they will be asked to fill out several
      questionnaires on an MD Anderson computer. Participant will be asked questions about anxiety,
      pain, and spirituality. The questionnaires will take about 20 minutes to complete.

      Participant will have their heart rate and blood pressure taken, which will take about 3
      minutes to complete. Participant will then have an electroencephalogram (EEG) done. An EEG is
      used to view a person's brain waves. The EEG should take about 5 minutes to complete. During
      the EEG, a snug cap which contains small electrodes will be placed on the head to measure the
      electrical patterns coming from the brain--much like the way a doctor listens to
      participant's heart from the surface of their skin. The EEG cap will stay on participant's
      head until the end of the study.

      Study Groups:

      After the baseline information is collected, participant will be randomly assigned (as in the
      role of a die) to 1 of 3 study groups: 2 relaxation training groups or a standard care group.
      Based on the way the study is designed, there is a 1 in 5 (or 20%) chance that participant
      will be assigned to the standard care group, and a 4 in 5 (or 80%) chance that participant
      will be assigned to one of the relaxation groups. Both relaxation groups will focus on
      helping participant to relax by focusing on their breath. At the end of participation, all
      groups will be given a 25 minute relaxation audio CD created by the MD Anderson Integrative
      Medicine Program.

      Pre-Breast Biopsy Procedures:

      Participants assigned to the relaxation groups will be guided through relaxation techniques
      for 10 minutes before the biopsy. Participants assigned to the third group will listen to 10
      minutes of National Public Radio.

      Participant's heart rate and EEG activity will be recorded during this 10-minute period of
      time. At the end of the 10-minute period before the breast biopsy, participant's blood
      pressure will be taken again and they will complete a 5 minute questionnaire about anxiety.

      Breast Biopsy Procedures:

      When it is time for the biopsy procedure, the research assistant will go with participant to
      their procedure room. In the procedure room, the research assistant will continue to monitor
      participant's heart rate and EEG activity throughout the biopsy time. If participant is in
      one of the relaxation groups, the relaxation guide will also accompany participant to the
      procedure room and will continue to be guided through relaxation during the biopsy procedure.
      If participant is in the standard care group, they will be provided with the usual breast
      biopsy care. Participant will be asked to talk about any anxiety and pain at several times
      during the procedure. Participant will also be asked to rest with their eyes closed during
      the biopsy procedure.

      After the biopsy is finished, the research assistant will go with participant to a separate
      room, and they will have 5 minutes of EEG activity recorded, and their blood pressure will be
      taken. The EEG cap will then be removed, and participant will be asked to complete a
      questionnaire about their experience that will take less than 10 minutes to complete.

      This is an investigational study.

      Up to 85 participants will take part in this study. All will be enrolled at MD Anderson.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
time frame: 1 day
description: Trial considered successful if over 50% of eligible patients participate and at least 80% of the consented patients complete the sessions and all the measures for the study.
measure: Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB
time frame: 3-5 minute intervals throughout the SBB procedure
description: Participants provide a rating from 0-10, with a rating of 0 indicating ''no anxiety'' and 10 indicating ''worst possible anxiety'' at 3-5 minute intervals throughout the SBB procedure.
arm group label: Guided Meditation Group (GM)
arm group type: Experimental
description: Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
arm group label: Focused Breathing Group (FB)
arm group type: Active Comparator
description: Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB..
arm group label: Standard of Care Group (SC)
arm group type: Active Comparator
description: Participants listen to a 10 minute neutral-content audio clip from National Public Radio prior to stereotactic breast biopsy (SBB).
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
intervention type: Procedure
intervention name: Meditation
description: Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
arm group label: Focused Breathing Group (FB)
arm group label: Guided Meditation Group (GM)
intervention type: Procedure
intervention name: Electroencephalogram
description: Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
arm group label: Focused Breathing Group (FB)
arm group label: Guided Meditation Group (GM)
arm group label: Standard of Care Group (SC)
other name: EEG
intervention type: Behavioral
intervention name: Questionnaires
description: Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
arm group label: Focused Breathing Group (FB)
arm group label: Guided Meditation Group (GM)
arm group label: Standard of Care Group (SC)
other name: Surveys
intervention type: Procedure
intervention name: Heart Rate
description: Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
arm group label: Focused Breathing Group (FB)
arm group label: Guided Meditation Group (GM)
arm group label: Standard of Care Group (SC)
other name: HR
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorenzo Cohen, PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor