Criticall illness, patient comfort, stress
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: Children < 5 years old and with expected mechanical ventilatory support for at least 48 hours after inclusion. The age range is set to 5 years, as this reflects most children admitted to our PICU.
Exclusion criteria
Exclusion criteria: Children are excluded if they have a neurocognitive disorder, or if they are admitted post-operatively with an expected length of stay <48 hours, or a critical situation where end-of-life care is expected, or if they are deaf or suffer from any other hearing impairment, which would not allow for the Music Intervention to be administered. Also, children are excluded when the parents are unable to understand / speak Dutch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behaviour (COMFORT-B) scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include parental stress levels, changes in hemodynamic variables (heart rate, blood pressure), changes in respiratory parameters (respiration rate, oxygen saturation, pressure-rate product, pressure-time product), daily cumulative dose of benzodiazepines, alpha-2-agonists and opioids, on-demand boluses of benzodiazepines and opioids, number of asynchronous breaths, and DNA methylation of stress genes | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Groningen