NCT05541029

Music Listening: A Mechanistic Trial

Music Listening Interventions for Children Receiving Mechanical Ventilation: A Mechanistic Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
BEHAVIORAL	Live music	Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
BEHAVIORAL	Recorded music	Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
OTHER	Usual care	Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).

Timeline

• Start date: 2023-03-20
• Primary completion: 2027-04-08
• Completion: 2027-05-03
• First posted: 2022-09-15
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States