The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- O2 sats
研究概览
简要总结
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
入排标准
- 年龄范围
- 28 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Song of Kin
Voice (with or without guitar)- lullaby/ Holding meter
干预措施: Song of Kin (Behavioral)
Gato box
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
干预措施: Gato box (Other)
Ocean disc
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
干预措施: Ocean disc (Other)
Contingent singing
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
干预措施: Contingent singing (Other)
Tonal Vocal holding
Providing a 'blanket of tone' to comfort, engage or sedate
干预措施: Tonal Vocal holding (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
干预措施: Muted shaker (Other)
结局指标
主要结局
O2 sats
时间窗: up to 2 weeks
Oxygen saturation levels (O2 sats)
Heart Rate
时间窗: up to 2 weeks
Feeding (sucking and absorption) category
时间窗: 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)
时间窗: 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)
Respiratory Rate
时间窗: up to 2 weeks
Sleep category
时间窗: up to 2 weeks
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Activity level
时间窗: 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
次要结局
- Postpartum Bonding Questionnaire (PBQ )(Baseline)
研究者
Joanne Loewy
Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel
Icahn School of Medicine at Mount Sinai