An interventional study of Premature family music therapy intervention to support parenting, attachment bond and preterm development in Music Therapy, sponsored by Ospedale di Circolo - Fondazione Macchi. Status unknown at 1 site in Italy. Open to participants aged 23 Weeks to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Ospedale di Circolo - Fondazione Macchi · Not applicable, Interventional, and Treatment
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.
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
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 90 is close to the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ospedale di Circolo - Fondazione Macchi is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria, Preterm infants born, will be eligible for the study, if they will be:
Exclusion Criteria, we will exclude infants whose mothers will be:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This protocol is a Family Centered Care Music Therapy Intervention. The methodologies will provide early intervention from the first days of hospitalization in NICU and consist of music therapy sessions both "active" (parental chant, live music and lullaby) and "receptive" (listening to recorded tracks). The music therapy accompanies the newborn and the parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs that they will develop over time.Therapy sessions will be performed starting from three times per week, on three different days of the week, during the entire hospitalization of the enrolled infants. After discharge music therapy treatment will be performed once a week until twelve months of corrected age. Stress level of infants and parents and neurobehavioral and neurological development of children will be assessed.
Other: Premature family music therapy intervention to support parenting, attachment bond and preterm development
Music therapy is not administered in this group. Control group (no music therapy). During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit.
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.
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.
Time frame: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Oxygen's saturation
Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.
Time frame: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
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
Time frame: at 6 and 12 months of corrected age
Neuro-behavioral and neurological development of the child
Temperament detected by the test QUIT (Italian Questionnaires of Temperament Axia, 2002)
Time frame: at 6-12 months of corrected age
Neuro-behavioral and neurological development of the child
General movements (GM). Using digital recording and analysis.
Time frame: at 1-3-6-9-12 months of corrected age.
Neuro-behavioral and neurological development of the child
Griffiths Scale
Time frame: 12 months of corrected age
Plan to share: No
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Ospedale di Circolo - Fondazione Macchi