Trials / Unknown
UnknownNCT04335240
Premature Family Music Therapy Intervention (PFMI)
Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Ospedale di Circolo - Fondazione Macchi · Academic / Other
- Sex
- All
- Age
- 23 Weeks – 12 Months
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Premature family music therapy intervention to support parenting, attachment bond and preterm development | We have structured an integrated psychological and music therapeutic protocol that aims to limit or overcome neonatal long-term developmental morbidities, promote parenting and attachment bond in preterm infants. |
Timeline
- Start date
- 2021-04-30
- Primary completion
- 2021-09-01
- Completion
- 2022-12-01
- First posted
- 2020-04-06
- Last updated
- 2022-04-27
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04335240. Inclusion in this directory is not an endorsement.