<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/NCT02201836</url>
  </required_header>
  <id_info>
    <org_study_id>142-04</org_study_id>
    <nct_id>NCT02201836</nct_id>
  </id_info>
  <brief_title>The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma</brief_title>
  <official_title>The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The onset of asthma is particularly frightening for children. When the symptoms of asthma&#xD;
      decrease, children and parents forget about the maintenance and control of breath and lung&#xD;
      volume. Because adherence is so poor, asthma is known as the emergency room illness. The&#xD;
      playing of a wind instrument is a unique way to provide a creative means for children and&#xD;
      teens to understand both the impact of diaphramatic breathing and their ability to control it&#xD;
      as well. This study builds upon the evidence, though sparse, that suggest that the blowing of&#xD;
      a wind instrument with clinical music therapy intervention strengthens the muscles of&#xD;
      breathing and fortifies the incentive toward attending to the daily symptoms and general&#xD;
      management of asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2006</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>6 months</time_frame>
    <description>The Juniper Questionnaire is a stringent quality of life measure that provides interview for children and teens and their parents. It is one of the few scales that requires these interviews to occur separately, so that children and parents do not feel compelled to answer what they think the other desires to hear. We also used take home journals and a comprehensive medical assessment to learn of ER visits, missed school days, avoidance of medication, and allergens in the home, as well as socio-economic status - these factors are known in the literature to effect outcomes and exacerbations with this population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase volume capacity</measure>
    <time_frame>6 months</time_frame>
    <description>Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>One time music therapy session</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One time music therapy session which consists of music meditation, including as assessment/evaluation of confined body breathing function as expressed through drawing and coloring post music imagery session. This is followed by an entrainment wind playing/breath expansion music therapy intervention. At the end of the session, the subjects are given a donated wind instrument for play at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly group music therapy intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The weekly group music therapy intervention consists of children and teens using guided visualization and expressing their fears and or fantasies related to breathing with one another. This is followed by creative music improvisations with part-playing on flutes, slide whistles, recorders and melodicas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One time music therapy</intervention_name>
    <arm_group_label>One time music therapy session</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group music therapy</intervention_name>
    <arm_group_label>Weekly group music therapy intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between the ages of 7 and 18&#xD;
&#xD;
          -  diagnosed with asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  over 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Loewy, DA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</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>Asthma</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/NCT02201836
org study id: 142-04
nct id: NCT02201836
lead sponsor: 
has dmc: No
The onset of asthma is particularly frightening for children. When the symptoms of asthma
      decrease, children and parents forget about the maintenance and control of breath and lung
      volume. Because adherence is so poor, asthma is known as the emergency room illness. The
      playing of a wind instrument is a unique way to provide a creative means for children and
      teens to understand both the impact of diaphramatic breathing and their ability to control it
      as well. This study builds upon the evidence, though sparse, that suggest that the blowing of
      a wind instrument with clinical music therapy intervention strengthens the muscles of
      breathing and fortifies the incentive toward attending to the daily symptoms and general
      management of asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Quality of Life
time frame: 6 months
description: The Juniper Questionnaire is a stringent quality of life measure that provides interview for children and teens and their parents. It is one of the few scales that requires these interviews to occur separately, so that children and parents do not feel compelled to answer what they think the other desires to hear. We also used take home journals and a comprehensive medical assessment to learn of ER visits, missed school days, avoidance of medication, and allergens in the home, as well as socio-economic status - these factors are known in the literature to effect outcomes and exacerbations with this population.
measure: Increase volume capacity
time frame: 6 months
description: Spirometry enabled us to analyze the possible effects of wind playing on the child's breathing
arm group label: One time music therapy session
arm group type: Active Comparator
description: One time music therapy session which consists of music meditation, including as assessment/evaluation of confined body breathing function as expressed through drawing and coloring post music imagery session. This is followed by an entrainment wind playing/breath expansion music therapy intervention. At the end of the session, the subjects are given a donated wind instrument for play at home.
arm group label: Weekly group music therapy intervention
arm group type: Active Comparator
description: The weekly group music therapy intervention consists of children and teens using guided visualization and expressing their fears and or fantasies related to breathing with one another. This is followed by creative music improvisations with part-playing on flutes, slide whistles, recorders and melodicas.
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: One time music therapy
arm group label: One time music therapy session
intervention type: Other
intervention name: Group music therapy
arm group label: Weekly group music therapy intervention
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Joanne Loewy, DA
role: Principal Investigator
affiliation: Beth Israel Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma