Biosafety of Musical Instruments in the ICU

Nosocomial Infection Clinical Trial

Official title:

Efficacy of a Disinfection Protocol for Musical Instruments of a Music Therapy Service in Intensive Care Units

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05988853
• Other study ID #: MTBIOSAFETY01
• Status: Active, not recruiting
• Start date: March 27, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: Fundación Santa Fe de Bogota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 15, 2023
• Est. primary completion date: September 15, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cross Infection
• Nosocomial Infection

Intervention

Other:
• follow-up of patients
Follow-up of evidence of nosocomial infections of patients in music therapy

Locations

Country	Name	City	State
Colombia	Fundación Santa Fe de Bogotá	Bogotá	Bogotá D.C.

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATP bioluminescence tests	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
Primary	Microbial cultures	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