Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- HRV analysis
研究概览
简要总结
The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte". In NICU an integrated psychological and music therapeutic protocol has been structured. The protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. Protocol is named "Premature family music therapy intervention (PFMI): an Italian protocol to support parenting, attachment bond and preterm development". The methodologies will provide early intervention from the first days of hospitalization in NICU and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). Such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. The music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents.
This protocol it is a Family Centered Care Music Therapy Intervention.
详细描述
All infants will be enrolled when in stable clinical condition within two weeks after birth. Therapy sessions will take place minimum three times per week on three different days of the week directly at the unit during the entire hospitalization until discharge. After discharge music therapy treatment will be performed once a week until twelve months of corrected age.
The infant's wellbeing and relaxation during each session of music therapy will be measured using the following parameters:
HRV (Heart Rate Variability) analysis Oxygen's saturation Stress level of the child
Infants will be followed till 12 months of corrected age. Investigators will assess:
Neuro-behavioral and neurological development of the child Stress level of the parents
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
A prospective randomized controlled trial will be conducted. Infants will be divided in two subgroups: an intervention group (that will undergo music therapy treatment) and a control group. To evaluate the effectiveness of the protocol, the effects of treatment in the short- and long-term period will be evaluated, with particular reference to the clinical course, the neuro-behavioral development of the premature baby and the relationship with his parents.
入排标准
- 年龄范围
- 23 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •, Preterm infants born, will be eligible for the study, if they will be:
- •Born between 22+6- and 32-weeks postmenstrual age
- •Weight less than 1500 g
- •Free from major congenital defects
- •Free from cerebral and/or intraventricular hemorrhage
- •Singleton or twin gestation
- •No sensorineural hearing loss (at discharge, passed bilateral hearing screening)
- •Free from Necrotizing enterocolitis
- •Free from severe retinopathy
- •No asphyxiated
- •No terms of surgical relevance
- •Born from HIV negative and drug free mothers
排除标准
- •, we will exclude infants whose mothers will be:
- •Affected by drug dependence
- •Affected by psychosis or other severe mental health problems
- •Unable to adequately speak/understand Italian language
- •Younger than 18 years of age
- •Physically unable to participate
结局指标
主要结局
HRV analysis
时间窗: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
The heart rate variability is related to the interaction of the sympathetic nervous system (alarm system) and parasympathetic (vagal). HRV derives from the balance of Low Frequency (LF) and High Frequency (HF). LF parameter represents the Sympathetic System and is correlated to a state of stress, while HF parameter represents the Parasympathetic System and is correlated to a state of relaxation. The balance of the two parameters (represented by value 1), means that their relationship is a state of well-being.
Oxygen's saturation
时间窗: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.
次要结局
- Stress level of the parents(at 6 and 12 months of corrected age)
- Neuro-behavioral and neurological development of the child(12 months of corrected age)
研究者
Barbara Sgobbi
Principal Investigator
Ospedale di Circolo - Fondazione Macchi