The Use of Music for Neonates Post-Cardiac Surgery
Primary Purpose
Heart Defects, Congenital
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Defects, Congenital
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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music Therapy
Arm Description
Implement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit.
Outcomes
Primary Outcome Measures
Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy
Proportion of shifts with music therapy using the number of shifts during music therapy was initiated by number of eligible shifts
Feasibility of implementing 20-minute music therapy protocol: Proportion of shifts that the subject received the full 20- minute therapy uninterrupted
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
Bedside nurse perception 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.
Parent Satisfaction: survey
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.
Physiological Measure - Heart Rate
The beside nurses will record the heart rate of the neonate.
Physiological Measure - Blood Pressure
The beside nurses will record the blood pressure (including systolic and diastolic pressures) of the neonate.
Physiological Measure - Oxygen Saturation
The beside nurses will record the oxygen saturation of the neonate.
Physiological Measure - State Behavioral Scale
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.
Physiological Measure - Face, Legs, Activity, Cry, Consolability (FLACC) scale.
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.
Measuring sedation
The beside nurses will record if sedation was given.
Music Frequency
The beside nurses will record if the music therapy was stopped and the reason for stopping
Full Information
NCT ID
NCT03925584
First Posted
March 15, 2019
Last Updated
March 8, 2022
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03925584
Brief Title
The Use of Music for Neonates Post-Cardiac Surgery
Official Title
The Use of Music for Neonates Post-Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Implement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy
Description
Proportion of shifts with music therapy using the number of shifts during music therapy was initiated by number of eligible shifts
Time Frame
14 days or when mechanical ventilation is discontinued, whichever comes first
Title
Feasibility of implementing 20-minute music therapy protocol: Proportion of shifts that the subject received the full 20- minute therapy uninterrupted
Description
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
Time Frame
14 days or when mechanical ventilation is discontinued, whichever comes first
Secondary Outcome Measure Information:
Title
Bedside nurse perception of music therapy
Description
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.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Parent Satisfaction: survey
Description
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.
Time Frame
24 hours following completion of music therapy
Title
Physiological Measure - Heart Rate
Description
The beside nurses will record the heart rate of the neonate.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Physiological Measure - Blood Pressure
Description
The beside nurses will record the blood pressure (including systolic and diastolic pressures) of the neonate.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Physiological Measure - Oxygen Saturation
Description
The beside nurses will record the oxygen saturation of the neonate.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Physiological Measure - State Behavioral Scale
Description
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.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Physiological Measure - Face, Legs, Activity, Cry, Consolability (FLACC) scale.
Description
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.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Measuring sedation
Description
The beside nurses will record if sedation was given.
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Title
Music Frequency
Description
The beside nurses will record if the music therapy was stopped and the reason for stopping
Time Frame
Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Music for Neonates Post-Cardiac Surgery
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