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Music Listening: A Mechanistic Trial

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University of Pittsburgh

Status

Enrolling

Conditions

Critical Illness

Treatments

Behavioral: Recorded music
Other: Usual care
Behavioral: Live music

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05541029
K23HD106011 (U.S. NIH Grant/Contract)
STUDY22080069

Details and patient eligibility

About

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.

Full description

Children who are critically ill and receiving mechanical ventilation are at increased risks for experiencing high levels of stress and pain, which negatively impacts immediate and long-term health. The current standard of care for treating stress and pain is to provide analgesic and sedative medications, which are associated with increased risk of delirium and posttraumatic stress disorder. This randomized within-subject crossover trial will 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, to identify the key components of a music listening intervention and explore its mechanism of action, i.e., the biological pathway through which music listening decreases stress and pain.

Enrollment

171 estimated patients

Sex

All

Ages

2 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 2 months -17 years old
  • intubated and receiving MV
  • expected to have a PICU stay of >72 hours

Exclusion criteria

  • Primary caregiver does not read, write, and speak English
  • The child is not expected to survive the PICU stay
  • The child has deafness in both ears, has a history of musicogenic epilepsy, is receiving neuromuscular blockade infusion
  • The child has a diagnosis of COVID-19
  • The child was admitted for a new traumatic brain injury

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

171 participants in 6 patient groups

Live music > Recorded music > Usual Care
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music
Recorded music > Usual care > Live music
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music
Usual Care > Live music > Recorded music
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music
Live music > Usual Care > Recorded music
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music
Recorded music > Live music > Usual care
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music
Usual care > Recorded music > Live music
Experimental group
Description:
Order of conditions for the day
Treatment:
Behavioral: Live music
Other: Usual care
Behavioral: Recorded music

Trial contacts and locations

1

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Central trial contact

Jessica Eldridge

Data sourced from clinicaltrials.gov

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