Critical Illness
Conditions
Keywords
mechanical ventilation, pain, stress, anxiety
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.
Interventions
BEHAVIORALLive 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)
BEHAVIORALRecorded 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).
OTHERUsual 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).
Sponsors
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study team members responsible for collecting data pre-post session will be masked to the condition received and condition order.
Intervention model description
Participants will receive 3 conditions in a random order, via within-subject block randomization, each day for 3 consecutive days.
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTJessica Eldridge
PRINCIPAL_INVESTIGATORJessica M Jarvis, PhD
University of Pittsburgh
Outcome results
None listed