Recruiting

Music Listening

Sponsor:

University of Pittsburgh

Code:

NCT05541029

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Live music

Recorded music

Usual care

Study Details

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.

Conditions

Critical Illness

Study ID

NCT05541029

Start date

Mar 20, 2023

Status verified date

Jan, 2026

Completion date

May 3, 2027

Anticipated

Primary completion date

Apr 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

171 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Live music > Recorded music > Usual Care

Order of conditions for the day

experimental: Recorded music > Usual care > Live music

Order of conditions for the day

experimental: Usual Care > Live music > Recorded music

Order of conditions for the day

experimental: Live music > Usual Care > Recorded music

Order of conditions for the day

experimental: Recorded music > Live music > Usual care

Order of conditions for the day

experimental: Usual care > Recorded music > Live music

Order of conditions for the day

Interventions

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)

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).

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).

Primary outcome measure

  • Change in cortisol pre-post condition [ Time Frame: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days ]
  • Change in Interleukin-6 (IL6) pre-post condition [ Time Frame: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days ]
  • High Frequency (HF) Heart Rate Variability [ Time Frame: 1 hour prior through 2 hours post each condition, up to 3 days ]
  • Low Frequency (LF) Heart Rate Variability [ Time Frame: 1 hour prior through 2 hours post each condition, up to 3 days ]
  • HF to LF ration (HF/LF) Heart Rate Variability [ Time Frame: 1 hour prior through 2 hours post each condition, up to 3 days ]
  • Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability [ Time Frame: 1 hour prior through 2 hours post each condition, up to 3 days ]

Central Contacts and Locations

Central contacts

Jessica Eldridge

4126927143eldridgejl@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

More Information

Sponsor

University of Pittsburgh

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • mechanical ventilation
  • pain
  • stress
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-01-20.