Clinical trial NCT03925584: The Use of Music for Neonates Post-Cardiac Surgery
Official title: The Use of Music for Neonates Post-Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1. To explore the feasibility of implementing standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit.
2. To describe the safety of implementing standardized nurse-led music therapy in the CICU.
3. To gather data regarding sedation requirements of subjects during music therapy.
4. To describe the parents perspective regarding nurse-led music therapy in the CICU.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the feasibility of implementing nurse-led music therapy in a cohort of neonates admitted to the Cardiac Intensive Care Unit (CICU) post congenital heart surgery. In the proposed setting, the use of a standardized nurse-led music therapy protocol for post-operative neonates would build upon current successful nurse-led efforts to wean sedatives and opioid use for patients admitted to the CICU. The investigators believe data generated from this exploratory feasibility study may serve to further inform a larger study involving the use of music therapy in the cardiac intensive care.

Detailed description: A predetermined recording of a music playlist meeting the properties of sedative music is being developed in consultation with a Boston Children's Hospital (BCH) music therapist. Properties of sedative music include soothing, stable, constant, and relatively unchanging, slow tempo and light rhythmic emphasis, constant volume and rhythm, lullaby style, repetitious and no separate melody for chorus/bridge. The music recorded for the neonates has been produced specifically for this study. In accordance with the recommendations for soothing music, BCH Music Therapists have recorded English nursery rhymes (Figure 1) in the key of C major at 60bpm with acoustic guitar and voice. The playlist will be stored on an Apple iPod Touch and will be delivered through a Bluetooth speaker that is positioned centrally (so that the sound input is received binaurally) at the subjects head or feet for a period of 20 minutes once during a 12-hour shift for 14 days or until mechanical ventilation has been discontinued, whichever is first.

The literature supports a duration of up to 30 minutes of music therapy followed by at least 30 minutes of silence, with a maximum of four hours per day. Music played for longer than 30 minutes has the potential to be a source of over-stimulation/agitation. There is some evidence to suggest that playing music for long periods of time (two four-hour segments) has a negative effect. In addition, it seems reasonable and likely to assume that the neonate could have a period of 30 minutes when they will not require an intervention associated with post-operative care. The protocol will target a 20 minute playlist. This will allow for variation in the length of songs while ensuring that music will not be played for longer than 30 minutes. There will be at least 30 minutes of quiet between music therapy session.

Eligibility criteria: Inclusion Criteria:

* Greater than 37 weeks gestation,
* Between 0 to 30 days of age
* 24 hours post congenital heart surgery
* Receiving mechanical ventilation
* Background noise level (at bedside) at the time of music therapy must be 55dB or less.

Exclusion Criteria:

* Hemodynamically unstable or end of life
* If patient is in a closed Giraffe bed
* Evidence of hearing impairment
* Patient has known or suspected active seizure disorder

Primary outcomes:
measure: Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy
timeFrame: 14 days or when mechanical ventilation is discontinued, whichever comes first
measure: Feasibility of implementing 20-minute music therapy protocol: Proportion of shifts that the subject received the full 20- minute therapy uninterrupted
timeFrame: 14 days or when mechanical ventilation is discontinued, whichever comes first
Secondary outcomes:
measure: Bedside nurse perception of music therapy
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Parent Satisfaction: survey
timeFrame: 24 hours following completion of music therapy
measure: Physiological Measure - Heart Rate
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Physiological Measure - Blood Pressure
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Physiological Measure - Oxygen Saturation
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Physiological Measure - State Behavioral Scale
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Physiological Measure - Face, Legs, Activity, Cry, Consolability (FLACC) scale.
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Measuring sedation
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
measure: Music Frequency
timeFrame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: