The Effect of Music Therapy on Newborns

NCT03987165 | Completed DMC

• 1 other identifier: 1043190
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).

Conditions

Neonatal Abstinence Syndrome; Substance Withdrawal, Neonatal

Keywords

Neonatal Opioid Withdrawal Syndrome

Outcome Measures

Primary Outcomes (6)

• Change in Heart Rate

  Infant's heart rate before, during and after music therapy and during the control session.

  Change in average heart rate over the 20 minute sessions (both control and music therapy)

• Change in Heart Rate Variability

  Infant's heart rate variability before, during and after music therapy and during the control session.

  Change in average heart rate variability over the 20 minute sessions (both control and music therapy)

• Change in Sleeping Patterns

  Basic parameters of sleeping - Type of sleep during control and intervention periods, including but not limited to, active/alert, quiet alert, sleeping. We will monitor time from end of feeding to start of sleep.

  Change in phase of sleep over the 20 minute sessions (both control and music therapy)

• Change in Feeding Patterns

  Time between the end of feeding and the onset of sleeping, with music therapy to be conducted during feeding.

  Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)

• Morphine Utilization

  Total cumulative dosage of morphine required during the infant's hospitalization as well as the total number of days on morphine. We will also determine the day of the maximum morphine dosage required by the infant.

  From day of birth through day of discharge, up to 6 months

• Total Length of Stay

  The total number of days the infant was hospitalized, from day of birth to day of discharge from the NICU

  From day of birth through day of discharge, up to 6 months

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music therapy by a certified music therapist will be delivered to infants over a period of 5 days. There will be two periods of data collection each day, one in the morning and one in the afternoon. Each baby will receive music therapy during one of these time points, with each baby serving as their own control during the second timepoint.

Other: Music Therapy

Control

NO INTERVENTION

Interventions

Music Therapy OTHER

Music therapy will be conducted once daily using a Song of Kin, a familiar song used to lull the infant to sleep. If no Song of Kin is provided, "Twinkle Twinkle Little Star" will be the default lullaby.

Music Therapy

Eligibility Criteria

• Age: 1 Minute - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to the NICU or newborn nursery
• Corrected gestational age 34 weeks or older
• No identified hearing disorder
• Do not have a diagnosed developmental disability (i.e. Down Syndrome)
• Do not have Fetal Alcohol Syndrome
• Medically cleared to participate in the study
• Parent or legal guardian able/willing to give consent \& complete surveys.

You may not qualify if:

• Corrected gestational age \< 34 weeks old
• Has an identified hearing disorder
• Has diagnosed developmental disability (i.e. Down syndrome)
• Has Fetal Alcohol Syndrome
• Is not medically cleared to participate in the study
• Parent or legal guardian unable/unwilling to give consent

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane Lakeside Hospital - Tulane University

Metairie, Louisiana, 70001, United States

Location

Related Publications (1)

• Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.

  PMID: 33348423 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Meghan P Howell, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross over design with each baby serving as its own control

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: December 10, 2018
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)