Music TherapyPFMINCT04335240
Premature Family Music Therapy Intervention (PFMI)
A study testing Premature family music therapy intervention to support parenting, attachment bond and preterm development in people with Music Therapy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 23 weeks to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 weeks to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria, 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 12. Born from HIV negative and drug free mothers
Exclusion Criteria, 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale F. Del Ponte
Varese, 21100
Barbara Sgobbi, +390332299421, barbarasgobbi@gmail.com
Laura Morlacchi, MD, +390332299420, laura.morlacchi@asst-settelaghi.it
About this study
Official title: Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
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.
Read the 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
- Music Therapy
- Being tested
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Keywords
- Music therapy, NICU, Preterm, Infants, Music, HRV, Neurodevelopment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premature family music therapy intervention to support parenting, attachment bond and preterm developmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Intervention | Experimental | 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. Receives: Other: Premature family music therapy intervention to support parenting, attachment bond and preterm development |
| No music therapy intervention | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Secondary outcomes (4)
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
Measured: 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)
Measured: at 6-12 months of corrected age
Neuro-behavioral and neurological development of the child
General movements (GM). Using digital recording and analysis.
Measured: at 1-3-6-9-12 months of corrected age.
Neuro-behavioral and neurological development of the child
Griffiths Scale
Measured: 12 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start30 Apr 2021
- Primary completion1 Sep 2021
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Massimo Agosti, MD, Principal investigator, Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335240
- Sponsor's protocol ID
- 31
- Acronym
- PFMI
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
- ClinicalTrials.gov ID
- NCT04335240
- Acronym / sponsor ID
- PFMI / 31
- Conditions
- Music Therapy
- Keywords
- Music therapy, NICU, Preterm, Infants, Music, HRV, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Intervention | Experimental | Other: Premature family music therapy intervention to support parenting, attachment bond and preterm developmentThis 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. |
| No music therapy intervention | No intervention | –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. |
Who may qualify
- Ages
- 23 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Premature family music therapy intervention to support parenting, attachment bond and preterm developmentWe 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. | Other | Music Therapy Intervention |
Primary outcome
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.
4 secondary outcomes
Stress level of the parents
Time frame: at 6 and 12 months of corrected age
Neuro-behavioral and neurological development of the child
Time frame: at 6-12 months of corrected age
Neuro-behavioral and neurological development of the child
Time frame: at 1-3-6-9-12 months of corrected age.
Neuro-behavioral and neurological development of the child
Time frame: 12 months of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Agosti, MD principal investigator
Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premature family music therapy intervention to support parenting, attachment bond and preterm development in people with Music Therapy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara S Sgobbi, MA (+390332299421, barbarasgobbi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRV analysis (time frame: through test completion, starting from 5 minutes before the test until 5 minutes after test ended). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.