Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

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

Detailed Description
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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.

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

Conditions
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NAS

Intervention / Treatment
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* Behavioral: Song of Kin
* Other: Gato box
* Other: Ocean disc
* Other: Contingent singing
* Other: Tonal Vocal holding
* Other: Muted shaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Song of Kin<br>Voice (with or without guitar)- lullaby/ Holding meter | Behavioral: Song of Kin<br>* 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.<br>* Other names: Music psychotherapy with parent/s;|
| Experimental: Gato box<br>Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate | Other: Gato box<br>* 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<br>* Other names: Rhythmic entrainment;|
| Experimental: Ocean disc<br>Creating a consistent womb-like sound soundscape to comfort, engage or sedate | Other: Ocean disc<br>* 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.<br>* Other names: Timbre entrainment;|
| Experimental: Contingent singing<br>Provision of communicative vocalization-parantese to engage with infants, prosodic responses to infant cues (eye contact, body position) | Other: Contingent singing<br>* 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<br>|
| Experimental: Tonal Vocal holding<br>Providing a 'blanket of tone' to comfort, engage or sedate | Other: Tonal Vocal holding<br>* Music therapist will provide a vowel, long held tone, sung without vibrato<br>|
| Experimental: Muted shaker<br>If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate | Other: Muted shaker<br>* If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate |  | up to 2 weeks | 
| Respiratory Rate |  | up to 2 weeks | 
| O2 sats | Oxygen saturation levels (O2 sats) | up to 2 weeks | 
| Activity level | 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 | up to 2 weeks | 
| Sleep category | The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying. | up to 2 weeks | 
| Feeding (sucking and absorption) category | The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage) | up to 2 weeks | 
| Neonatal Abstinence Scoring (NAS) | 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) | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum Bonding Questionnaire (PBQ ) | 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). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Abstinence Syndrome, Music therapy, Attachment, Music medicine, Multi-modal stimulation