Music Listening: A Mechanistic Trial

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05541029
Status
Recruiting
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Conditions

  • Critical Illness

Eligibility Criteria

Sex
ALL
Age
2 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Live music — BEHAVIORAL
    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 — BEHAVIORAL
    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 — OTHER
    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).

Study Details

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.

Key Dates

Start date
Mar 20, 2023
Status verified
Jan 2026
Primary completion
Apr 8, 2027
Completion
May 3, 2027

Study Design

Enrollment
171 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Jessica M Jarvis, PhD

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By research site
UPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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