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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Song of Kin | Music 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. |
| OTHER | Gato box | Depending 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 |
| OTHER | Ocean disc | Depending 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. |
| OTHER | Contingent singing | Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep |
| OTHER | Tonal Vocal holding | Music therapist will provide a vowel, long held tone, sung without vibrato |
| OTHER | Muted shaker | If 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.