Clinical trial NCT05988853: Biosafety of Musical Instruments in the ICU
Official title: Efficacy of a Disinfection Protocol for Musical Instruments of a Music Therapy Service in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Infection
Keywords: music therapy
biosafety
musical instruments
intensive care units
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized that have been part of the music therapy service from July 1st to August 31st 2023.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ATP bioluminescence tests
timeFrame: 2 months
measure: Microbial cultures
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
state: Bogotá D.C.
Study officials:
References: