Music Listening: a Mechanistic Trial
- Conditions
- Critical Illness
- Interventions
- Behavioral: Live musicBehavioral: Recorded musicOther: Usual care
- Registration Number
- NCT05541029
- Lead Sponsor
- University of Pittsburgh
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 171
- 2 months -17 years old
- intubated and receiving MV
- expected to have a PICU stay of >72 hours
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Live music > Recorded music > Usual Care Recorded music Order of conditions for the day Recorded music > Usual care > Live music Live music Order of conditions for the day Recorded music > Usual care > Live music Usual care Order of conditions for the day Usual Care > Live music > Recorded music Live music Order of conditions for the day Usual Care > Live music > Recorded music Recorded music Order of conditions for the day Usual care > Recorded music > Live music Live music Order of conditions for the day Live music > Usual Care > Recorded music Usual care Order of conditions for the day Live music > Usual Care > Recorded music Live music Order of conditions for the day Live music > Recorded music > Usual Care Live music Order of conditions for the day Recorded music > Usual care > Live music Recorded music Order of conditions for the day Live music > Usual Care > Recorded music Recorded music Order of conditions for the day Usual Care > Live music > Recorded music Usual care Order of conditions for the day Recorded music > Live music > Usual care Recorded music Order of conditions for the day Live music > Recorded music > Usual Care Usual care Order of conditions for the day Recorded music > Live music > Usual care Usual care Order of conditions for the day Usual care > Recorded music > Live music Usual care Order of conditions for the day Recorded music > Live music > Usual care Live music Order of conditions for the day Usual care > Recorded music > Live music Recorded music Order of conditions for the day
- Primary Outcome Measures
Name Time Method High Frequency (HF) Heart Rate Variability 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.
Low Frequency (LF) Heart Rate Variability 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.
Change in cortisol pre-post condition 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.
Change in Interleukin-6 (IL6) pre-post condition 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.
HF to LF ration (HF/LF) Heart Rate Variability 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.
Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability 1 hour prior through 2 hours post each condition, up to 3 days Trajectory of SDNN, a biomarker of parasympathetic and sympathetic modulation
- Secondary Outcome Measures
Name Time Method Acceptability 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.
Change in Visual Analogue Scale of Anxiety 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.
Change in Face Legs Activity Consolability and Crying (FLACC) 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.
Trial Locations
- Locations (1)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States