Heart Defects, CongenitalNCT03925584
The Use of Music for Neonates Post-Cardiac Surgery
A study testing Music Therapy in people with Heart Defects, Congenital, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2019to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Heart Defects, Congenital
- Being tested
- Music Therapy
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Implement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days or when mechanical ventilation is discontinued, whichever comes first
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
Measured: 14 days or when mechanical ventilation is discontinued, whichever comes first
Secondary outcomes (9)
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.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
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.
Measured: 24 hours following completion of music therapy
Physiological Measure - Heart Rate
The beside nurses will record the heart rate of the neonate.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Physiological Measure - Blood Pressure
The beside nurses will record the blood pressure (including systolic and diastolic pressures) of the neonate.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Physiological Measure - Oxygen Saturation
The beside nurses will record the oxygen saturation of the neonate.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
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.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
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.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Measuring sedation
The beside nurses will record if sedation was given.
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Music Frequency
The beside nurses will record if the music therapy was stopped and the reason for stopping
Measured: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start20 Jul 2019
- Primary completion1 Mar 2020
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Connor, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925584
- Sponsor's protocol ID
- IRB-P00030729
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Music for Neonates Post-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03925584
- Acronym / sponsor ID
- IRB-P00030729
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyImplement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit. |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyStandardized 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 | Other | Music Therapy |
Primary outcome
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
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
9 secondary outcomes
Bedside nurse perception of music therapy
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Parent Satisfaction: survey
Time frame: 24 hours following completion of music therapy
Physiological Measure - Heart Rate
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Physiological Measure - Blood Pressure
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Physiological Measure - Oxygen Saturation
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Physiological Measure - State Behavioral Scale
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
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
Measuring sedation
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Music Frequency
Time frame: Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Heart Defects, Congenital, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.