Biosafety of Musical Instruments in the ICU

Sponsor
Fundación Santa Fe de Bogota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05988853
Collaborator
(none)
150
1
8.6
17.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: follow-up of patients

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy of a Disinfection Protocol for Musical Instruments of a Music Therapy Service in Intensive Care Units
Actual Study Start Date :
Mar 27, 2023
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Outcome Measures

Primary Outcome Measures

  1. ATP bioluminescence tests [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. Microbial cultures [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fundación Santa Fe de Bogotá Bogotá Bogotá D.C. Colombia 110111

Sponsors and Collaborators

  • Fundación Santa Fe de Bogota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Ettenberger, Coordinator Music Therapy Service, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier:
NCT05988853
Other Study ID Numbers:
  • MTBIOSAFETY01
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark Ettenberger, Coordinator Music Therapy Service, Fundación Santa Fe de Bogota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023