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NCT Number: NCT05541029

Music Listening: A Mechanistic Trial

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.

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Key information

Conditions

Critical Illness Anxiety Disorders Disease Attributes Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Jessica M Jarvis, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

    Percent change in saliva-based cortisol level, ng/ml. Reported as median change per condition and included as continuous outcome in linear regression.

  2. 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

    Percent change in saliva-based IL6 level, pg/ml. Reported as median change per condition and included as continuous outcome in linear regression.

  3. High Frequency (HF) Heart Rate Variability

    Time frame: 1 hour prior through 2 hours post each condition, up to 3 days

    Trajectory of HF, a biomarker of sympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.

  4. Low Frequency (LF) Heart Rate Variability

    Time frame: 1 hour prior through 2 hours post each condition, up to 3 days

    Trajectory of LF, a biomarker of parasympathetic nervous activity. Reported as median value per condition and included as continuous outcome in linear regression.

  5. HF to LF ration (HF/LF) Heart Rate Variability

    Time frame: 1 hour prior through 2 hours post each condition, up to 3 days

    Trajectory of HF/LF ratio, a biomarker of autonomic nervous system balance. Reported as median value per condition and included as continuous outcome in linear regression.

  6. 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

    Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation

Secondary outcomes

  1. Acceptability

    Time frame: Interviews conducted within 1 month of completing primary data collection

    Qualitative interviews with participants on intervention benefits, limitations, and optimizations. Reported as themes and sub-themes.

  2. Change in Visual Analogue Scale of Anxiety

    Time frame: Change <30 min. pre-post each condition for up to 3 days

    Percent change in caregiver self-reported anxiety, scaled 0 [no anxiety] to 100 [extremely anxious]. Reported as median change per condition and included as continuous outcome in linear regression.

  3. Change in Face Legs Activity Consolability and Crying (FLACC)

    Time frame: Change <30 min. pre-post each condition for up to 3 days

    Percent change in observed pain, as measured by FLACC. Each of the 5 domains (e.g., Face, legs, etcs) is scored 0-2 and combined for a total score of 0 through 10, higher number indicates more pain. FLACC change score will be calculated from scores pre/post each condition. Reported as median change per condition and included as continuous outcome in linear regression.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Eldridge

CONTACT

[email protected]

4126927143

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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