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/NCT05988853</url>
    </required_header>
    <id_info>
      <org_study_id>MTBIOSAFETY01</org_study_id>
      <nct_id>NCT05988853</nct_id>
    </id_info>
    <brief_title>Biosafety of Musical Instruments in the ICU</brief_title>
    <official_title>Efficacy of a Disinfection Protocol for Musical Instruments of a Music Therapy Service in Intensive Care Units</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundación Santa Fe de Bogota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundación Santa Fe de Bogota</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 study investigates the efficacy of the institutional disinfection protocol for musical&#xD;
        instruments in the ICU of the music therapy service of the University Hospital Fundación&#xD;
        Santa Fe de Bogotá (FSFB), Colombia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: Nosocomial infections can negatively affect the recovery and well-being of&#xD;
        patients. Music therapy is a profession that uses music and sounds to improve the health,&#xD;
        well-being and quality of life of patients. Musical instruments are regularly used in music&#xD;
        therapy sessions, such as the string or percussion instruments, among others. Since the&#xD;
        musical instruments are also played and handled by the patients, the question arises if the&#xD;
        disinfection and cleaning protocol for musical instruments of the music therapy service at&#xD;
        the University Hospital Fundación Santa Fe de Bogotá (FSFB) is effective and safe.&#xD;
  &#xD;
        Objectives: To establish the effectiveness and impact of the disinfection protocol of musical&#xD;
        instruments used by the music therapy service in the ICUs of the FSFB.&#xD;
  &#xD;
        Methodology: This is a study carried out in 2 phases. The first phase corresponds to an&#xD;
        experimental design in which the presence of microbiological viability will be evaluated&#xD;
        through ATP bioluminescence tests and cultures before and after the application of the&#xD;
        disinfection and cleaning protocol in a controlled environment. The second phase corresponds&#xD;
        to a prospective cohort study in which music therapy patients will be followed up ver a&#xD;
        period of two months, determining the impact of the disinfection and cleaning protocol.&#xD;
  &#xD;
        Analysis: A descriptive analysis will be applied where the qualitative variables will be&#xD;
        presented in their absolute and relative frequencies. For the quantitative variables, the&#xD;
        Kolgomorov-Smirnov test will be applied to define the distribution of the data and, according&#xD;
        to these, corresponding descriptive statistics will be carried out. In addition, a bivariate&#xD;
        analysis will be performed between the outcome variable (infection or not) versus the&#xD;
        exposure variables with a regression-type confounding analysis (logistic - binary as&#xD;
        applicable) to identify co-variability phenomena.&#xD;
  &#xD;
        Expected results: This study seeks to improve patient safety, raise awareness in the music&#xD;
        therapy community about the importance of proper cleaning of their work tools, and promote&#xD;
        inter- and transdisciplinary knowledge between the fields of music therapy, critical medicine&#xD;
        and epidemiology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 27, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ATP bioluminescence tests</measure>
      <time_frame>2 months</time_frame>
      <description>ATP bioluminescence detects the amount of ATP, which is an indirect measurement of the amount of organic residue on a surface that has the potential to support microbial growth and also microbial biomass.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Microbial cultures</measure>
      <time_frame>2 months</time_frame>
      <description>Will be taken if the ATP is positive (USP 42 &lt;61&gt;) or at least 10 microbial cultures will be taken randomly from the musical instruments used in the ICU</description>
    </primary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Nosocomial Infection</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>follow-up of patients</intervention_name>
      <description>Follow-up of evidence of nosocomial infections of patients in music therapy</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients hospitalized that have been part of the music therapy service from July 1st to&#xD;
          August 31st 2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being hospitalized in the and having participated in a music therapy service from July&#xD;
               1st to August 31st 2023.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not having participated in a music therapy service during the same time frame.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Fundación Santa Fe de Bogotá</name>
        <address>
          <city>Bogotá</city>
          <state>Bogotá D.C.</state>
          <zip>110111</zip>
          <country>Colombia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Colombia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fundación Santa Fe de Bogota</investigator_affiliation>
      <investigator_full_name>Mark Ettenberger</investigator_full_name>
      <investigator_title>Coordinator Music Therapy Service</investigator_title>
    </responsible_party>
    <keyword>music therapy</keyword>
    <keyword>biosafety</keyword>
    <keyword>musical instruments</keyword>
    <keyword>intensive care units</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cross Infection</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be shared upon request.</ipd_description>
    </patient_data>
    <!-- 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/NCT05988853
  org study id: MTBIOSAFETY01
  nct id: NCT05988853
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study investigates the efficacy of the institutional disinfection protocol for musical
        instruments in the ICU of the music therapy service of the University Hospital Fundación
        Santa Fe de Bogotá (FSFB), Colombia.
  Introduction: Nosocomial infections can negatively affect the recovery and well-being of
        patients. Music therapy is a profession that uses music and sounds to improve the health,
        well-being and quality of life of patients. Musical instruments are regularly used in music
        therapy sessions, such as the string or percussion instruments, among others. Since the
        musical instruments are also played and handled by the patients, the question arises if the
        disinfection and cleaning protocol for musical instruments of the music therapy service at
        the University Hospital Fundación Santa Fe de Bogotá (FSFB) is effective and safe.
  
        Objectives: To establish the effectiveness and impact of the disinfection protocol of musical
        instruments used by the music therapy service in the ICUs of the FSFB.
  
        Methodology: This is a study carried out in 2 phases. The first phase corresponds to an
        experimental design in which the presence of microbiological viability will be evaluated
        through ATP bioluminescence tests and cultures before and after the application of the
        disinfection and cleaning protocol in a controlled environment. The second phase corresponds
        to a prospective cohort study in which music therapy patients will be followed up ver a
        period of two months, determining the impact of the disinfection and cleaning protocol.
  
        Analysis: A descriptive analysis will be applied where the qualitative variables will be
        presented in their absolute and relative frequencies. For the quantitative variables, the
        Kolgomorov-Smirnov test will be applied to define the distribution of the data and, according
        to these, corresponding descriptive statistics will be carried out. In addition, a bivariate
        analysis will be performed between the outcome variable (infection or not) versus the
        exposure variables with a regression-type confounding analysis (logistic - binary as
        applicable) to identify co-variability phenomena.
  
        Expected results: This study seeks to improve patient safety, raise awareness in the music
        therapy community about the importance of proper cleaning of their work tools, and promote
        inter- and transdisciplinary knowledge between the fields of music therapy, critical medicine
        and epidemiology.
  observational model: Cohort
  time perspective: Prospective
  measure: ATP bioluminescence tests
  time frame: 2 months
  description: ATP bioluminescence detects the amount of ATP, which is an indirect measurement of the amount of organic residue on a surface that has the potential to support microbial growth and also microbial biomass.
  measure: Microbial cultures
  time frame: 2 months
  description: Will be taken if the ATP is positive (USP 42 <61>) or at least 10 microbial cultures will be taken randomly from the musical instruments used in the ICU
  intervention type: Other
  intervention name: follow-up of patients
  description: Follow-up of evidence of nosocomial infections of patients in music therapy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  facility: 
  country: Colombia
  responsible party type: Principal Investigator
  investigator affiliation: Fundación Santa Fe de Bogota
  investigator full name: Mark Ettenberger
  investigator title: Coordinator Music Therapy Service
  mesh term: Cross Infection
  sharing ipd: No
  ipd description: Data will be shared upon request.