The Use of Music for Neonates Post-Cardiac Surgery

NCT03925584 | Completed

• 1 other identifier: IRB-P00030729
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days or when mechanical ventilation is discontinued, whichever comes first

Secondary Outcomes (9)

• Bedside nurse perception of music therapy

  Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy

• Parent Satisfaction: survey

  24 hours following completion of music therapy

• Physiological Measure - Heart Rate

  Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy

• Physiological Measure - Blood Pressure

  Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy

• Physiological Measure - Oxygen Saturation

  Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy

Study Arms (1)

Music Therapy

EXPERIMENTAL

Implement standardized nurse-led music therapy for neonates post congenital heart surgery who are admitted to the cardiac intensive care unit.

Other: Music Therapy

Interventions

Music Therapy OTHER

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

Music Therapy

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research, Cardiovascular and Critical Care Services

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 24, 2019
• Study Start: July 20, 2019
• Primary Completion: March 1, 2020
• Study Completion: February 15, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (1)