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Clinical Trials/NCT04335240
NCT04335240
Unknown
Not Applicable

Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development

Ospedale di Circolo - Fondazione Macchi1 site in 1 country90 target enrollmentApril 30, 2021
ConditionsMusic Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music Therapy
Sponsor
Ospedale di Circolo - Fondazione Macchi
Enrollment
90
Locations
1
Primary Endpoint
HRV analysis
Last Updated
4 years ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
April 30, 2021
End Date
December 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ospedale di Circolo - Fondazione Macchi
Responsible Party
Principal Investigator
Principal Investigator

Barbara Sgobbi

Principal Investigator

Ospedale di Circolo - Fondazione Macchi

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

HRV analysis

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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