Premature Family Music Therapy Intervention (PFMI)

Music Therapy Clinical Trial

— PFMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335240
• Other study ID #: 31
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: Barbara S Sgobbi, MA
• Phone: +390332299421
• Email: barbarasgobbi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Weeks to 12 Months

Eligibility

Inclusion Criteria, Preterm infants born, will be eligible for the study, if they will be:

1. Born between 22+6- and 32-weeks postmenstrual age

2. Weight less than 1500 g

3. Free from major congenital defects

4. Free from cerebral and/or intraventricular hemorrhage

5. Singleton or twin gestation

6. No sensorineural hearing loss (at discharge, passed bilateral hearing screening)

7. Free from Necrotizing enterocolitis

8. Free from severe retinopathy

9. No asphyxiated

11. No terms of surgical relevance 12. Born from HIV negative and drug free mothers

Exclusion Criteria, we will exclude infants whose mothers will be:

1. Affected by drug dependence

2. Affected by psychosis or other severe mental health problems

3. Unable to adequately speak/understand Italian language

4. Younger than 18 years of age

5. Physically unable to participate

Related Conditions & MeSH terms

• Music Therapy
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale F. Del Ponte	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRV analysis	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.	through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Primary	Oxygen's saturation	Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.	through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Secondary	Stress level of the parents	Parenting Stress Index-Short Form (PSI-SF, Abidin, 1995; Italian version edited by Guarino et al., 2007) at 6-12 months of corrected age State-Trait Anxiety Scale (STAI; Spielberger, 1983; Italian validation of Pedrabissi and Santinello (1996) at 6-12 months of corrected age Beck Depression Inventory (BDI, Beck, 1967) at 6-12 months of corrected age	at 6 and 12 months of corrected age
Secondary	Neuro-behavioral and neurological development of the child	Temperament detected by the test QUIT (Italian Questionnaires of Temperament Axia, 2002)	at 6-12 months of corrected age
Secondary	Neuro-behavioral and neurological development of the child	General movements (GM). Using digital recording and analysis.	at 1-3-6-9-12 months of corrected age.
Secondary	Neuro-behavioral and neurological development of the child	Griffiths Scale	12 months of corrected age