Music Listening: A Mechanistic Trial

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 months to 17 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Critical Illness

Being tested

Live music, Recorded music, Usual care

Keywords

mechanical ventilation, pain, stress, anxiety

Medical subject headings

Critical Illness, Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Live musicBehavioural

  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 musicBehavioural

  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 careOther

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change in cortisol pre-post condition

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

   Measured: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days

2. Change in Interleukin-6 (IL6) pre-post condition

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

   Measured: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days

3. High Frequency (HF) Heart Rate Variability

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

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

4. Low Frequency (LF) Heart Rate Variability

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

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

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

   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.

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

6. Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability

   Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Sep 2022
2. Study start20 Mar 2023
3. Primary completion8 Apr 2027 (estimated)
4. Study completion3 May 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Critical IllnessStudies of the same condition, open and under way.
• More trials run by University of PittsburghThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.