Music Listening: A Mechanistic Trial

Official title

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

Overview

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

• Behavioral Live 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)
• Behavioral Recorded 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
• Other Usual 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 providi

Primary outcome measures

• 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]
• 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]
• High Frequency (HF) Heart Rate Variability [Time frame: 1 hour prior through 2 hours post each condition, up to 3 days]
• Low Frequency (LF) Heart Rate Variability [Time frame: 1 hour prior through 2 hours post each condition, up to 3 days]
• HF to LF ration (HF/LF) Heart Rate Variability [Time frame: 1 hour prior through 2 hours post each condition, up to 3 days]
• 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]

Secondary outcome measures (3)

• Acceptability [Time frame: Interviews conducted within 1 month of completing primary data collection]
• Change in Visual Analogue Scale of Anxiety [Time frame: Change <30 min. pre-post each condition for up to 3 days]
• Change in Face Legs Activity Consolability and Crying (FLACC) [Time frame: Change <30 min. pre-post each condition for up to 3 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• UPMC Children's Hospital of Pittsburgh — Pittsburgh

Publications

• Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670. PMID 23689789
• Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159. PMID 31652195
• Bush HI, LaGasse AB, Collier EH, Gettis MA, Walson K. Effect of Live Versus Recorded Music on Children Receiving Mechanical Ventilation and Sedation. Am J Crit Care. 2021 Sep 1;30(5):343-349. doi: 10.4037/ajcc2021646. PMID 34467386

Identifiers

NCT: NCT05541029 · STUDY22080069 · K23HD106011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗