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/NCT05966766</url>
    </required_header>
    <id_info>
      <org_study_id>00003958</org_study_id>
      <nct_id>NCT05966766</nct_id>
    </id_info>
    <brief_title>Dosing Music for Anxiety Reduction in Parturients</brief_title>
    <official_title>Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Scheduled Cesarean Delivery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tufts Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tufts Medical 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>
        This is a clinical study that aims to determine the effective dose of music listening&#xD;
        duration that is required to reduce anxiety in patients awaiting scheduled cesarean section.&#xD;
        It will also compare types of music to accomplish this goal, both of which have been shown&#xD;
        effective in prior studies. Methods will involve enrolling and playing music for patients&#xD;
        awaiting scheduled C-section, and scoring their anxiety with pre- and post-music&#xD;
        questionnaires. Music duration for each subject will be predetermined, and analysis of&#xD;
        response will be performed to determine the effective dose 95%, or dose at which 95% of&#xD;
        subjects should have a positive response.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety Score</measure>
      <time_frame>1-8 hours</time_frame>
      <description>STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Mozart</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patient preference</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mozart selections</intervention_name>
      <description>Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.</description>
      <arm_group_label>Mozart</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient-preferred music selections</intervention_name>
      <description>Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.</description>
      <arm_group_label>Patient preference</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Planning on scheduled cesarean section&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
            -  American Society of Anaesthesiologists (ASA) physical status score of II-III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  Impaired hearing&#xD;
  &#xD;
            -  Patient is taking at least one anxiolytic medication daily at baseline&#xD;
  &#xD;
            -  No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after&#xD;
               consent is given&#xD;
  &#xD;
            -  ASA IV or higher&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dan Drzymalski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tufts Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dan Drzymalski, MD</last_name>
      <phone>617-913-8168</phone>
      <email>ddrzymalski@tuftsmedicalcenter.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tristan Fong, BS</last_name>
      <email>tristan.fong@tufts.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tufts Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02111</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dan Drzymalski, MD</last_name>
        <phone>617-913-8168</phone>
        <email>ddrzymalski@tuftsmedicalcenter.org</email>
      </contact>
      <investigator>
        <last_name>Dan Drzymalski, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tristan Fong, BS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT05966766
  org study id: 00003958
  nct id: NCT05966766
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a clinical study that aims to determine the effective dose of music listening
        duration that is required to reduce anxiety in patients awaiting scheduled cesarean section.
        It will also compare types of music to accomplish this goal, both of which have been shown
        effective in prior studies. Methods will involve enrolling and playing music for patients
        awaiting scheduled C-section, and scoring their anxiety with pre- and post-music
        questionnaires. Music duration for each subject will be predetermined, and analysis of
        response will be performed to determine the effective dose 95%, or dose at which 95% of
        subjects should have a positive response.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Anxiety Score
  time frame: 1-8 hours
  description: STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.
  arm group label: Mozart
  arm group type: Active Comparator
  description: Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.
  arm group label: Patient preference
  arm group type: Active Comparator
  description: Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
  intervention type: Other
  intervention name: Mozart selections
  description: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.
  arm group label: Mozart
  intervention type: Other
  intervention name: Patient-preferred music selections
  description: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.
  arm group label: Patient preference
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dan Drzymalski, MD
  role: Principal Investigator
  affiliation: Tufts Medical Center
  last name: Dan Drzymalski, MD
  phone: 617-913-8168
  email: ddrzymalski@tuftsmedicalcenter.org
  last name: Tristan Fong, BS
  email: tristan.fong@tufts.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Anxiety Disorders