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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

The Use of Music for Neonates Post-Cardiac Surgery

Clinicaltrials.gov identifier NCT03925584

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 14, 2020

Study Description

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.

  • Condition or Disease:Heart Defects, Congenital
  • Intervention/Treatment: Other: Music Therapy
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: 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. To describe the safety of implementing standardized nurse-led music therapy in the CICU. To gather data regarding sedation requirements of subjects during music therapy. To describe the parents perspective regarding nurse-led music therapy in the CICU.
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: The Use of Music for Neonates Post-Cardiac Surgery
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Music Therapy
Implement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit.
Other: Music Therapy
Standardized music playlist will be played centrally 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
Outcome Measures
  • Primary Outcome Measures: 1. Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy [ Time Frame: 14 days or when mechanical ventilation is discontinued, whichever comes first ]
    Proportion of shifts with music therapy using the number of shifts during music therapy was initiated by number of eligible shifts
  • 2. Feasibility of implementing 20-minute music therapy protocol: Proportion of shifts that the subject received the full 20- minute therapy uninterrupted [ Time Frame: 14 days or when mechanical ventilation is discontinued, whichever comes first ]
    Proportion of shifts that the subject received the full 20- minute therapy uninterrupted using the number of shifts receiving the full therapy by the number of eligible therapy sessions
  • Secondary Outcome Measures: 1. Bedside nurse perception of music therapy [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    Bedside nurse will provide information on the ease or difficulty in administering the music therapy and to report any difficulties. Nurses will state if perceived the music therapy to provide any benefit as well as any additional comments or feedback.
  • 2. Parent Satisfaction: survey [ Time Frame: 24 hours following completion of music therapy ]
    Parents will be given a survey regarding satisfaction with the music therapy and any additional comments. Questions include satisfaction with music therapy, enjoyment of music, and beneficial/positive effects on infant and on parent themselves. Questions will be asked using a 5-point Likert scale ranging from Strongly Disagree to Strongly Agree. The rating for each question will range from 1 to 5. Strongly Disagree will be measured as 1, Disagree will be measured as 2, Neutral will be measured as 3, Agree will be measured as 4, and Strongly Agree will be measured as 5. The means/average of each question will be analysed. Questions rating 4.0 or higher will be considered as satisfaction. Average scores of 3.0-3.9 are considered Neutral, and Average scores below 3.0 are considered unsatisfied. There is also a section to allow for the parents to add additional comments on thoughts on the music therapy.
  • 3. Physiological Measure - Heart Rate [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record the heart rate of the neonate.
  • 4. Physiological Measure - Blood Pressure [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record the blood pressure (including systolic and diastolic pressures) of the neonate.
  • 5. Physiological Measure - Oxygen Saturation [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record the oxygen saturation of the neonate.
  • 6. Physiological Measure - State Behavioral Scale [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record the state behavioral scale (SBS) of the neonate. The SBS is determined by the Score as patient's response to voice then gentle touch then noxious stimuli (planned endotracheal suctioning or <5 seconds of nail bed pressure). SBS scores range from -3 to +2. The score for -3 is unresponsive, -2 is responsive to noxious stimuli, -1 is responsive to gentle touch or voice, 0 is awake and able to calm, +1 is restless and difficult to calm, and +2 is agitated.
  • 7. Physiological Measure - Face, Legs, Activity, Cry, Consolability (FLACC) scale. [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record the FLACC scale of the neonate. Each category of the FLACC score is rated from 0 to 2. The total score ranges between 0 and 10. For Face, 0 is no particular expression or smile, 1 is occasional grimace or frown; withdrawn, disinterested, 2 is frequent to constant frown, clenched jaw, quivering chin. For Legs, 0 is normal position or relaxed, 1 is uneasy, restless, tense, 2 is kicking or legs drawn up. For Activity, 0 is lying quietly, normal position, moves easily, 1 is squirming, shifting back and forth, tense, 2 is arched, rigid, or jerking. For Cry, 0 is no cry (awake or asleep), 1 is moans or whimpers, occasional complaint, 2 is crying steadily, screams or sobs; frequent complaints. For Consolability, 0 is content, relaxed, 1 is reassured by occasional touching, hugging or being talked to; distractable, and 2 is difficult to console or comfort.
  • 8. Measuring sedation [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record if sedation was given.
  • 9. Music Frequency [ Time Frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy ]
    The beside nurses will record if the music therapy was stopped and the reason for stopping
Eligibility Criteria
  • Ages Eligible for Study: up to 30 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Angela Sorensen, BSN, RN 781-219-7448 Angela.Sorensen@childrens.harvard.edu

Contact: Jean Connor, PHD 617-355-8890 Jean.Connor@CARDIO.CHBOSTON.ORG

Locations

United States, Massachusetts
Boston Children's Hospital
Boston

Sponsors and Collaborators

Boston Children's Hospital

More Information
  • Responsible Party: Boston Children's Hospital
  • ClinicalTrials.gov Identifier: NCT03925584 History of Changes
  • Other Study ID Numbers: IRB-P00030729
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 14, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Heart Defects, Congenital Congenital Abnormalities