NAS
Conditions
Keywords
Neonatal Abstinence Syndrome, Music therapy, Attachment, Music medicine, Multi-modal stimulation
Brief 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.
Interventions
BEHAVIORALSong 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.
OTHERGato 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
OTHEROcean 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.
OTHERContingent 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
OTHERTonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato
OTHERMuted shaker
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
Intervention model description
Counterbalancing will be achieved by assigning a different order of presentation of conditions for each group. Participants will remain in the study for two weeks, but continue to receive music therapy for the duration of their stay in the NICU.
Eligibility
Sex/Gender
ALL
Age
28 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender: * Admitted to the NICU immediately postpartum * Gestational age 28 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 by nurse or neonatologist * Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire)
Exclusion criteria
* Admitted to the NICU at any time other than immediately postpartum * Gestational age \<28 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 by the nurse or neonatologist * Parent or legal guardian unable/unwilling to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | up to 2 weeks | — |
| Respiratory Rate | up to 2 weeks | — |
| O2 sats | up to 2 weeks | Oxygen saturation levels (O2 sats) |
| Activity level | up to 2 weeks | The neonatologist or nurse will assess and mark as active/alert, active to stimulation, flaccid, hypertonic, hypotonic, irritable, jittery, lethargic, paralyzed\&medicated, quiet, sedated, or tremors |
| Sleep category | up to 2 weeks | The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying. |
| Feeding (sucking and absorption) category | up to 2 weeks | The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage) |
| Neonatal Abstinence Scoring (NAS) | up to 2 weeks | The NAS score lists 21 symptoms that are most frequently observed in opiate-exposed infants. Each symptom and its associated degree of severity are assigned a score and the total abstinence score is determined by totalling the score assigned to each symptom over the scoring period. Please provide the full scale info (example 0 (no symptoms) to 10 (severe symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Bonding Questionnaire (PBQ ) | Baseline | Questionnaire to assess capacity for attachment in both mothers and fathers. 25 item scale with each item rated from always to never. Scoring is based on four categories: impaired bonding scores 0-60, rejection and pathological anger scores 0-35, infant-focused anxiety scores 0-20, and incipient abuse scores 0-10. Total range from 0 (good bonding) to 125 (poor bonding). |
Countries
United States
Contacts
CONTACTJoanne Loewy, DA, LCAT, MT-BC
CONTACTElizabeth Barone, MA, MT-BC, CCLS
PRINCIPAL_INVESTIGATORJoanne Loewy, PhD
Icahn School of Medicine at Mount Sinai
PRINCIPAL_INVESTIGATORKathy Murphy, PhD
Loyola University
STUDY_DIRECTORAimee Telsey, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed