<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/NCT01669733</url>
  </required_header>
  <id_info>
    <org_study_id>CASE5112</org_study_id>
    <nct_id>NCT01669733</nct_id>
  </id_info>
  <brief_title>The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery</brief_title>
  <official_title>The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to study the effect music has on women undergoing surgical&#xD;
      breast biopsy. Through the facilitation of live and/or recorded music listening, we will&#xD;
      examine the perception of patient anxiety, the total amount of propofol required to obtain a&#xD;
      BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the&#xD;
      effect of live and/or recorded music on patient satisfaction. It is hypothesized that:&#xD;
&#xD;
        1. Patients in the live and recorded music groups will experience less anxiety than the&#xD;
           non-music (standard care) group.&#xD;
&#xD;
        2. Patients in the live and recorded music groups will experience a reduction in the amount&#xD;
           of anesthesia needed to reach a state of moderate sedation compared to the non-music&#xD;
           (standard care) group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Music therapy's effect on anxiety in Preoperative.(live vs. recorded):&#xD;
&#xD;
      If the patient is randomly selected to the live music group, the music therapist will prepare&#xD;
      a preferred song to be performed live in the preoperative room. If the patient is randomly&#xD;
      selected for the recorded music group, she will be given an iPod and headphones and will&#xD;
      listen to a recorded version of her preferred song. If the patient is randomly selected for&#xD;
      the control group, she will receive standard care and no music. Pre/posttests will be given&#xD;
      using a Global Anxiety Visual Analog Scale (GA-VAS).&#xD;
&#xD;
      Music therapy's effect on propofol requirements intraoperatively:&#xD;
&#xD;
      Subjects in the live music group and subjects in the recorded music group will listen to&#xD;
      recorded music intraoperatively. All subjects will receive equal amounts of fentanyl and&#xD;
      versed. Subjects will receive fentanyl in the amount of 1 microgram per kilogram and versed&#xD;
      (midazolam) in the amount of 0.02 milligrams per kilogram from the nurse anesthetist. An ipod&#xD;
      with headphones will be given to the subject when she is being prepared to move to the&#xD;
      operating room. The board certified music therapist will initiate recorded music (harp&#xD;
      selections). Recorded music will be relaxing harp selections. The board certified music&#xD;
      therapist will accompany the subject to the operating room and assure volume levels and&#xD;
      electronic equipment function properly.&#xD;
&#xD;
      Anesthesia personnel will apply BIS monitor before propofol administration. Anesthesia&#xD;
      personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol&#xD;
      in micrograms per kilogram per minute, infusing at that point. Signal Quality Index (SQI)&#xD;
      will be recorded when the BIS reaches 70 to give credibility to the BIS monitor. SQI is a&#xD;
      measure of the signal quality for the EEG channel source and is calculated based on impedance&#xD;
      data, artifact, and other variables. The total amount of propofol for the case will be&#xD;
      recorded as total milligrams received. Anesthesia personnel will record Observer's Assessment&#xD;
      of the Alertness/Sedation (OAA/S) when BIS monitor reaches 70 or below as incidental data&#xD;
      point. A score of 3 on OAA/S indicates that the patient responds only after mild prodding and&#xD;
      shaking. OAA/S will be compared to BIS reading.&#xD;
&#xD;
      Time in PACU and Patient Satisfaction:&#xD;
&#xD;
      Recorded music will continue playing until the subject has met discharge criteria according&#xD;
      to University Hospital's policy and procedure. The amount of time between when the patient&#xD;
      leaves the operating room and meets discharge criteria (determined by nurse) will be&#xD;
      recorded. Patient satisfaction will be recorded using a Likert scale: 7= highly satisfied;&#xD;
      1=not at all satisfied after the subject has met her discharge criteria.&#xD;
&#xD;
      Controls: The control group subjects will receive standard anesthesia, nursing and surgical&#xD;
      care. All rating procedures will be the same. Controls will wear noise reducing headphones.&#xD;
      The music therapist will not accompany control patients following surgery. When the trial is&#xD;
      complete, the music therapist will offer the control subject a CD of the recorded music once&#xD;
      she has met discharge criteria and all data is recorded. This will occur for the sake of&#xD;
      ethics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</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>The cumulative intra-operative dose of propofol(mg) given to each patient</measure>
    <time_frame>at the time of surgery</time_frame>
    <description>The primary outcome for this study will be the amount of propofol administered intra-operatively. Each of the groups receiving music pre-operatively and/or peri-operatively will be compared to the control (no music) group. Anesthesia personnel will apply BIS (Bispectral Index Monitor) monitor before propofol administration. Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point. The total amount of propofol for the case will be recorded as total milligrams received.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anxiety levels</measure>
    <time_frame>Pr- and post- music therapy prior to surgery</time_frame>
    <description>Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS). A pretest will be given in the preoperative area before intervention and a posttest will be given after the live song, the recorded song, or five minutes of standard care has occurred. The investigators will measure the subject's marking (vertical line) on the GA-VAS from the left side of the GA-VAS to the subject's line using millimeters on a ruler.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of time in the PACU (post-anesthesia care unit)</measure>
    <time_frame>at time of discharge from PACU</time_frame>
    <description>Amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) using a clock.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction to music therapy</measure>
    <time_frame>at the time of PACU discharge</time_frame>
    <description>Qualitative data will be taken on the subject's subjective comments regarding their thoughts about their surgical experience using a 1-10 Likert Scale.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Abnormal Breast Tissue</condition>
  <arm_group>
    <arm_group_label>Live/Recorded Music Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The music therapist will prepare a preferred song to be performed live in the preoperative room. Subjects in the live music group will listen to recorded music intraoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recorded Music Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recorded music group will be given an iPod and headphones and will listen to a recorded version of a preferred song.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Music (Standard of care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive standard of care and no music.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <description>Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.</description>
    <arm_group_label>Live/Recorded Music Group</arm_group_label>
    <arm_group_label>Recorded Music Group</arm_group_label>
    <other_name>Recorded Music</other_name>
    <other_name>Live Music</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>The control group subjects will receive standard anesthesia, nursing and surgical care.</description>
    <arm_group_label>No Music (Standard of care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who will undergo surgical breast biopsy under monitored anesthesia care&#xD;
&#xD;
          -  English speaking women&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  ASA classification of I (no systematic disease) or II (mild to moderate disease who&#xD;
             are medically stable) or III (severe systematic disease, not incapacitating)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with profound mental illness&#xD;
&#xD;
          -  with developmental disability&#xD;
&#xD;
          -  with significant hearing loss where music would not be heard from headphones&#xD;
&#xD;
          -  currently taking narcotics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deforia Lane, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>August 21, 2015</last_update_submitted>
  <last_update_submitted_qc>August 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Surgery</keyword>
  <keyword>Breast Biopsy</keyword>
  <keyword>Music Therapy</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/NCT01669733
org study id: CASE5112
nct id: NCT01669733
lead sponsor: 
has dmc: No
The purpose of this research is to study the effect music has on women undergoing surgical
      breast biopsy. Through the facilitation of live and/or recorded music listening, we will
      examine the perception of patient anxiety, the total amount of propofol required to obtain a
      BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the
      effect of live and/or recorded music on patient satisfaction. It is hypothesized that:

        1. Patients in the live and recorded music groups will experience less anxiety than the
           non-music (standard care) group.

        2. Patients in the live and recorded music groups will experience a reduction in the amount
           of anesthesia needed to reach a state of moderate sedation compared to the non-music
           (standard care) group.
Music therapy's effect on anxiety in Preoperative.(live vs. recorded):

      If the patient is randomly selected to the live music group, the music therapist will prepare
      a preferred song to be performed live in the preoperative room. If the patient is randomly
      selected for the recorded music group, she will be given an iPod and headphones and will
      listen to a recorded version of her preferred song. If the patient is randomly selected for
      the control group, she will receive standard care and no music. Pre/posttests will be given
      using a Global Anxiety Visual Analog Scale (GA-VAS).

      Music therapy's effect on propofol requirements intraoperatively:

      Subjects in the live music group and subjects in the recorded music group will listen to
      recorded music intraoperatively. All subjects will receive equal amounts of fentanyl and
      versed. Subjects will receive fentanyl in the amount of 1 microgram per kilogram and versed
      (midazolam) in the amount of 0.02 milligrams per kilogram from the nurse anesthetist. An ipod
      with headphones will be given to the subject when she is being prepared to move to the
      operating room. The board certified music therapist will initiate recorded music (harp
      selections). Recorded music will be relaxing harp selections. The board certified music
      therapist will accompany the subject to the operating room and assure volume levels and
      electronic equipment function properly.

      Anesthesia personnel will apply BIS monitor before propofol administration. Anesthesia
      personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol
      in micrograms per kilogram per minute, infusing at that point. Signal Quality Index (SQI)
      will be recorded when the BIS reaches 70 to give credibility to the BIS monitor. SQI is a
      measure of the signal quality for the EEG channel source and is calculated based on impedance
      data, artifact, and other variables. The total amount of propofol for the case will be
      recorded as total milligrams received. Anesthesia personnel will record Observer's Assessment
      of the Alertness/Sedation (OAA/S) when BIS monitor reaches 70 or below as incidental data
      point. A score of 3 on OAA/S indicates that the patient responds only after mild prodding and
      shaking. OAA/S will be compared to BIS reading.

      Time in PACU and Patient Satisfaction:

      Recorded music will continue playing until the subject has met discharge criteria according
      to University Hospital's policy and procedure. The amount of time between when the patient
      leaves the operating room and meets discharge criteria (determined by nurse) will be
      recorded. Patient satisfaction will be recorded using a Likert scale: 7= highly satisfied;
      1=not at all satisfied after the subject has met her discharge criteria.

      Controls: The control group subjects will receive standard anesthesia, nursing and surgical
      care. All rating procedures will be the same. Controls will wear noise reducing headphones.
      The music therapist will not accompany control patients following surgery. When the trial is
      complete, the music therapist will offer the control subject a CD of the recorded music once
      she has met discharge criteria and all data is recorded. This will occur for the sake of
      ethics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The cumulative intra-operative dose of propofol(mg) given to each patient
time frame: at the time of surgery
description: The primary outcome for this study will be the amount of propofol administered intra-operatively. Each of the groups receiving music pre-operatively and/or peri-operatively will be compared to the control (no music) group. Anesthesia personnel will apply BIS (Bispectral Index Monitor) monitor before propofol administration. Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point. The total amount of propofol for the case will be recorded as total milligrams received.
measure: Change in anxiety levels
time frame: Pr- and post- music therapy prior to surgery
description: Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS). A pretest will be given in the preoperative area before intervention and a posttest will be given after the live song, the recorded song, or five minutes of standard care has occurred. The investigators will measure the subject's marking (vertical line) on the GA-VAS from the left side of the GA-VAS to the subject's line using millimeters on a ruler.
measure: Amount of time in the PACU (post-anesthesia care unit)
time frame: at time of discharge from PACU
description: Amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) using a clock.
measure: Patient satisfaction to music therapy
time frame: at the time of PACU discharge
description: Qualitative data will be taken on the subject's subjective comments regarding their thoughts about their surgical experience using a 1-10 Likert Scale.
arm group label: Live/Recorded Music Group
arm group type: Experimental
description: The music therapist will prepare a preferred song to be performed live in the preoperative room. Subjects in the live music group will listen to recorded music intraoperatively.
arm group label: Recorded Music Group
arm group type: Experimental
description: Recorded music group will be given an iPod and headphones and will listen to a recorded version of a preferred song.
arm group label: No Music (Standard of care)
arm group type: Active Comparator
description: The control group will receive standard of care and no music.
intervention type: Other
intervention name: Music
description: Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
arm group label: Live/Recorded Music Group
arm group label: Recorded Music Group
other name: Recorded Music
other name: Live Music
intervention type: Other
intervention name: Standard of Care
description: The control group subjects will receive standard anesthesia, nursing and surgical care.
arm group label: No Music (Standard of care)
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Deforia Lane, PhD
role: Principal Investigator
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor