Usual care for Critical Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA
Critical Illness
Usual care - Other
Eligibility
< 18
All Sexes
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Study Summary

A randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Critical Illness

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 20 minutes prior through 2 hours post condition, up to 3 days

Day 3
HF to LF ration (HF/LF) Heart Rate Variability
Day 3
Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability
Day 3
Low Frequency (LF) Heart Rate Variability
Day 3
High Frequency (HF) Heart Rate Variability
Day 3
Change in Beta-Endorphins (B-End)
Change in Face Legs Activity Consolability and Crying (FLACC)
Change in Interleukin-6 (IL6) pre-post condition
Change in Visual Analogue Scale of Anxiety
Change in cortisol pre-post condition
Week 2
Acceptability

Trial Safety

Safety Progress

1 of 3

Other trials for Critical Illness

Trial Design

6 Treatment Groups

Usual care > Recorded music > Live music
1 of 6
Recorded music > Usual care > Live music
1 of 6
Recorded music > Live music > Usual care
1 of 6
Usual Care > Live music > Recorded music
1 of 6
Live music > Usual Care > Recorded music
1 of 6
Live music > Recorded music > Usual Care
1 of 6
Experimental Treatment

171 Total Participants · 6 Treatment Groups

Primary Treatment: Usual care · No Placebo Group · N/A

Usual care > Recorded music > Live musicExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Recorded music > Usual care > Live musicExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Recorded music > Live music > Usual careExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Usual Care > Live music > Recorded musicExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Live music > Usual Care > Recorded musicExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Live music > Recorded music > Usual CareExperimental Group · 3 Interventions: Usual care, Recorded music, Live music · Intervention Types: Other, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Live music
2010
N/A
~350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes prior through 2 hours post condition, up to 3 days
Closest Location: UPMC Children's Hospital of Pittsburgh · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
2021First Recorded Clinical Trial
2 TrialsResearching Critical Illness
16 CompletedClinical Trials

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,411 Total Patients Enrolled
13 Trials studying Critical Illness
4,938 Patients Enrolled for Critical Illness
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,785 Previous Clinical Trials
2,221,627 Total Patients Enrolled
5 Trials studying Critical Illness
2,324 Patients Enrolled for Critical Illness
Jessica M Jarvis, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Critical Illness
38 Patients Enrolled for Critical Illness

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.