<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/NCT03239587</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0808</org_study_id>
    <nct_id>NCT03239587</nct_id>
  </id_info>
  <brief_title>Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires and Proteomic Analysis</brief_title>
  <official_title>Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires, Proteomic Analysis, and Neuroimaging</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 research study is to learn if simulated live piano music can change the&#xD;
      amount of stress felt in patients with cancer before surgery, health care providers caring&#xD;
      for cancer patients, and/or hospital volunteers.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be&#xD;
      enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, you will be randomly assigned (as in the flip of a&#xD;
      coin) to 1 of 2 study groups. Participants in the first group will wait for 30 minutes in a&#xD;
      standard pre-surgery waiting area without music. Participants in the other group will go to a&#xD;
      waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano&#xD;
      music.&#xD;
&#xD;
      A Steinway Spirio grand piano is a special type of piano that plays music by itself (also&#xD;
      called a player piano). The music will be chosen by the study staff and pre-recorded on the&#xD;
      piano. Although the keys will move on the piano as if someone is playing the piano, you will&#xD;
      be alone in the room.&#xD;
&#xD;
      You will have an equal chance (50/50) of being assigned to either group. Both you and the&#xD;
      person in charge of this study will know to which group you have been assigned. You do not&#xD;
      get to choose which group you are in.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      Before and about 30 minutes after you either listen to music or stand in the waiting room&#xD;
      without music:&#xD;
&#xD;
        -  Blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding&#xD;
           to the music or silence by measuring the amount of cortisol in your body (a type of&#xD;
           hormone related to stress) and for biomarker testing. Biomarkers are found in the blood&#xD;
           and may be related to your reaction to the music or silence. If you are a healthcare&#xD;
           provider or volunteer, you will not have these blood draws.&#xD;
&#xD;
        -  You will complete 2 questionnaires about your anxiety and stress levels. It should take&#xD;
           about 20-30 minutes to complete.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      You participation on this study will be over after the last blood draw and questionnaire are&#xD;
      completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants&#xD;
  </why_stopped>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">April 24, 2018</completion_date>
  <primary_completion_date type="Actual">April 24, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Defined Musical Intervention on Perceived Stress in Preoperative Cancer Participants</measure>
    <time_frame>1 day</time_frame>
    <description>Effect of defined musical intervention on perceived stress measured by the Spielberger State-Trait Anxiety Inventory (STAI-S).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Symptoms and Signs Involving Cognition Perception Emotion &amp; Behaviour</condition>
  <condition>Abdominal Cancer Patients</condition>
  <arm_group>
    <arm_group_label>No Musical Intervention - Control Group</arm_group_label>
    <description>Participants wait for 30 minutes in a standard pre-surgery waiting area without music.&#xD;
Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.&#xD;
Participants complete 2 questionnaires about anxiety and stress levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Musical Intervention Group</arm_group_label>
    <description>Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.&#xD;
Blood drawn before, and about 30 minutes after participant in the waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.&#xD;
Participants complete 2 questionnaires about anxiety and stress levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Musical Intervention</intervention_name>
    <description>Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.</description>
    <arm_group_label>Musical Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draws</intervention_name>
    <description>No Musical Intervention - Control Group: Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.&#xD;
Musical Intervention Group: Blood drawn before, and about 30 minutes after in waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.</description>
    <arm_group_label>Musical Intervention Group</arm_group_label>
    <arm_group_label>No Musical Intervention - Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.</description>
    <arm_group_label>Musical Intervention Group</arm_group_label>
    <arm_group_label>No Musical Intervention - Control Group</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood (about 1½ teaspoons each time) drawn before and about 30 minutes after participant&#xD;
      either listens to music or stands in the waiting room without music.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer participants waiting for surgery at UT MD Anderson Cancer Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) Patients: To preserve a homogenous cohort and comply with the departmentally-organized&#xD;
        research infrastructure, we will include pPreoperative abdominal cancer patients undergoing&#xD;
        surgery, or healthcare provider from all specialties at MDACC or volunteer from MDACC&#xD;
        Volunteer Service.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cannot give informed consent&#xD;
&#xD;
          2. Are deaf or hearing-disabled&#xD;
&#xD;
          3. Less than 18 years in age&#xD;
&#xD;
          4. Profess extreme dislike of music.&#xD;
&#xD;
          5. Wait time is longer than 240 min.&#xD;
&#xD;
          6. Underlying structural brain abnormality or neurologic comorbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudius Conrad, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Symptoms and signs involving cognition perception emotion &amp; behaviour</keyword>
  <keyword>Abdominal cancer patients</keyword>
  <keyword>Musical preop intervention</keyword>
  <keyword>Surveys</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Blood draws</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03239587
org study id: 2016-0808
nct id: NCT03239587
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn if simulated live piano music can change the
      amount of stress felt in patients with cancer before surgery, health care providers caring
      for cancer patients, and/or hospital volunteers.

      This is an investigational study.

      Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be
      enrolled in this study. All will take part at MD Anderson.
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
      coin) to 1 of 2 study groups. Participants in the first group will wait for 30 minutes in a
      standard pre-surgery waiting area without music. Participants in the other group will go to a
      waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano
      music.

      A Steinway Spirio grand piano is a special type of piano that plays music by itself (also
      called a player piano). The music will be chosen by the study staff and pre-recorded on the
      piano. Although the keys will move on the piano as if someone is playing the piano, you will
      be alone in the room.

      You will have an equal chance (50/50) of being assigned to either group. Both you and the
      person in charge of this study will know to which group you have been assigned. You do not
      get to choose which group you are in.

      Study Procedures:

      Before and about 30 minutes after you either listen to music or stand in the waiting room
      without music:

        -  Blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding
           to the music or silence by measuring the amount of cortisol in your body (a type of
           hormone related to stress) and for biomarker testing. Biomarkers are found in the blood
           and may be related to your reaction to the music or silence. If you are a healthcare
           provider or volunteer, you will not have these blood draws.

        -  You will complete 2 questionnaires about your anxiety and stress levels. It should take
           about 20-30 minutes to complete.

      Length of Study:

      You participation on this study will be over after the last blood draw and questionnaire are
      completed.
observational model: Case-Control
time perspective: Prospective
measure: Effect of Defined Musical Intervention on Perceived Stress in Preoperative Cancer Participants
time frame: 1 day
description: Effect of defined musical intervention on perceived stress measured by the Spielberger State-Trait Anxiety Inventory (STAI-S).
arm group label: No Musical Intervention - Control Group
description: Participants wait for 30 minutes in a standard pre-surgery waiting area without music.
Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.
Participants complete 2 questionnaires about anxiety and stress levels.
arm group label: Musical Intervention Group
description: Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
Blood drawn before, and about 30 minutes after participant in the waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
Participants complete 2 questionnaires about anxiety and stress levels.
intervention type: Behavioral
intervention name: Musical Intervention
description: Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
arm group label: Musical Intervention Group
intervention type: Procedure
intervention name: Blood Draws
description: No Musical Intervention - Control Group: Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.
Musical Intervention Group: Blood drawn before, and about 30 minutes after in waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
arm group label: Musical Intervention Group
arm group label: No Musical Intervention - Control Group
intervention type: Behavioral
intervention name: Questionnaires
description: Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.
arm group label: Musical Intervention Group
arm group label: No Musical Intervention - Control Group
other name: Surveys
Blood (about 1½ teaspoons each time) drawn before and about 30 minutes after participant
      either listens to music or stands in the waiting room without music.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudius Conrad, MD, PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Abdominal Neoplasms