Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03533985

Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
28 Weeks
Healthy volunteers
Not accepted

Summary

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

Detailed description

The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSong of KinMusic therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
OTHERGato boxDepending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
OTHEROcean discDepending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
OTHERContingent singingDepending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
OTHERTonal Vocal holdingMusic therapist will provide a vowel, long held tone, sung without vibrato
OTHERMuted shakerIf infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Timeline

Start date
2017-11-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2018-05-23
Last updated
2025-02-24

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03533985. Inclusion in this directory is not an endorsement.