- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988853
Biosafety of Musical Instruments in the ICU
Efficacy of a Disinfection Protocol for Musical Instruments of a Music Therapy Service in Intensive Care Units
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bogotá D.C.
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Bogotá, Bogotá D.C., Colombia, 110111
- Fundacion Santa Fe de Bogota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being hospitalized in the and having participated in a music therapy service from July 1st to August 31st 2023.
Exclusion Criteria:
- Not having participated in a music therapy service during the same time frame.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ATP bioluminescence tests
Time Frame: 2 months
|
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.
|
2 months
|
|
Microbial cultures
Time Frame: 2 months
|
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
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTBIOSAFETY01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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