Music Listening for Critically Ill Children
This study is looking at how live music and recorded music affect stress and pain in children who are critically ill and on a breathing machine (mechanical ventilation) in the pediatric intensive care unit (PICU). Researchers want to see if music can help reduce stress and pain, which are currently managed with medications that can have side effects. You might be able to join if your child is between 2 months and 17 years old, is on a breathing machine, and is expected to stay in the PICU for more than 72 hours. The study will measure changes in stress hormones (cortisol) and inflammation markers (Interleukin-6 or IL6), as well as heart rate variability, to see if music helps. The current status of this study is unclear, but it plans to enroll 171 participants.
- Study design
- This is a randomized crossover study, meaning participants will receive different interventions in a random order. It aims to enroll 171 participants.
- What's involved
- Participants will receive live music, recorded music, and usual care. Measurements will be taken before and after each condition for up to 3 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken for up to 3 days after each condition.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Music Listening: A Mechanistic Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jessica M Jarvis, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in cortisol pre-post conditionChange from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
Percent change in saliva-based cortisol level, ng/ml. Reported as median change per condition and included as continuous outcome in linear regression.
- Change in Interleukin-6 (IL6) pre-post conditionChange from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
Percent change in saliva-based IL6 level, pg/ml. Reported as median change per condition and included as continuous outcome in linear regression.
- High Frequency (HF) Heart Rate Variability1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of HF, a biomarker of sympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
- Low Frequency (LF) Heart Rate Variability1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of LF, a biomarker of parasympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.
- HF to LF ration (HF/LF) Heart Rate Variability1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of HF/LF ratio, a biomarker of autonomic nervous system balance. Reported as median value per condition and included as continuous outcome in linear regression.
- Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability1 hour prior through 2 hours post each condition, up to 3 days
Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation