Clinical trial NCT05541029: Music Listening: a Mechanistic Trial
Official title: Music Listening Interventions for Children Receiving Mechanical Ventilation: a Mechanistic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: mechanical ventilation
pain
stress
anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-09-15
Enrollment: 171
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive 3 conditions in a random order, via within-subject block randomization, each day for 3 consecutive days.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cortisol pre-post condition
timeFrame: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
measure: Change in Interleukin-6 (IL6) pre-post condition
timeFrame: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days
measure: High Frequency (HF) Heart Rate Variability
timeFrame: 1 hour prior through 2 hours post each condition, up to 3 days
measure: Low Frequency (LF) Heart Rate Variability
timeFrame: 1 hour prior through 2 hours post each condition, up to 3 days
measure: HF to LF ration (HF/LF) Heart Rate Variability
timeFrame: 1 hour prior through 2 hours post each condition, up to 3 days
measure: Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability
timeFrame: 1 hour prior through 2 hours post each condition, up to 3 days
Secondary outcomes:
measure: Acceptability
timeFrame: Interviews conducted within 1 month of completing primary data collection
measure: Change in Visual Analogue Scale of Anxiety
timeFrame: Change <30 min. pre-post each condition for up to 3 days
measure: Change in Face Legs Activity Consolability and Crying (FLACC)
timeFrame: Change <30 min. pre-post each condition for up to 3 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jessica M Jarvis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
citation: Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159.
citation: Bush HI, LaGasse AB, Collier EH, Gettis MA, Walson K. Effect of Live Versus Recorded Music on Children Receiving Mechanical Ventilation and Sedation. Am J Crit Care. 2021 Sep 1;30(5):343-349. doi: 10.4037/ajcc2021646.