Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03925584
Study type Interventional
Source Boston Children's Hospital
Contact
Status Completed
Phase N/A
Start date July 20, 2019
Completion date February 15, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05330338 - Genetics of Ventriculo-arterial Discordance N/A
Withdrawn NCT03405636 - Xeltis Pulmonary Valved Conduit Safety and Performance Study N/A
Completed NCT02443662 - Colloid Osmotic Pressure in Patients With Fontan Circulation
Terminated NCT02519335 - Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation Phase 1
Completed NCT01835392 - Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery N/A
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Completed NCT03035552 - CTICU Pacifier Activated Music Player and Mother's Voice N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Enrolling by invitation NCT04866537 - Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
Completed NCT03049540 - Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function Phase 3
Completed NCT02377674 - Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection N/A
Completed NCT01679275 - Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
Terminated NCT00543309 - Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery Phase 2
Completed NCT03957512 - Livet Skal Leves (A Life to Live)
Recruiting NCT06005428 - Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Phase 2
Recruiting NCT02691689 - Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions N/A
Completed NCT02306057 - Fluid Balance in Children Undergoing Fontan Surgery N/A
Recruiting NCT02157597 - NIRS Guidance Trail in Children's Heart Surgery N/A
Completed NCT01570933 - Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. Phase 4
Completed NCT00443599 - SPECS: Safe Pediatric Euglycemia in Cardiac Surgery N/A