Music TherapyNCT04759170
The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby
A study testing Music therapy in people with Music Therapy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on… Read more about this study
- Who is it for?
- Ages 23 to 34 weeks
- Conditions the study is for
- Music Therapy
- What is being tested?
- Music therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2020to 27 Dec 2021
- 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 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gestational age at birth between the 23rd and 34th week of gestation
- Neonates with intraventricular hemorrhage (IVH)
- Neonates with periventricular leukomalacia (PVL)
Who cannot join
- Only newborns in ventilatory support at the time of evaluation
- Newborns with maxillofacial malformations
- Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake
- Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby: Prospective Randomized Controlled Study Mom, Dad and Music Therapist Singing Voice
The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.
Read the detailed description
In preterm infant, oral feeding requires significant maturation of the nervous system to support coordination of the oropharyngeal muscles and breathing. Additionally, the energy expenditure required by nutritional sucking attempts further complicates the acquisition of oral feeding skills and must be balanced by caloric intake to achieve sufficient growth. Achievement of exclusive autonomous sucking typically occurs only between 34 and 36 post-conception weeks. However, delays in achieving full oral sucking are common and may prolong the infant's hospitalization.Non-nutritive sucking (NNS) is a coordinated motor skill that can be taught through an educational activity that conditions neuronal responses through positive reinforcement.The international literature demonstrates that, through a behavioral approach, the use of the pacifier during non-nutritive sucking promotes nutritional sucking in preterm infants, improving their attachment and bottle feeding, and determines the reduction of the length of stay in intensive care. and improved general well-being of the newborn.The use of receptive music therapy can therefore be supportive and represent a positive reinforcement for the development and acquisition of oral and nutritional skills of the preterm infant. By taking advantage of non-nutritive sucking it is possible to improve the suckling capacity of the newborn, his feeding speed, weight gain and consequently reduce the length of hospital stay. It is essential to achieve this result without negatively affecting the well-being and stability of the preterm infant.
Although musical studies in premature infants are limited, a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infant.On the other hand, the possible similar effects of reproduction, through the use of receptive music therapy of the song of the father and / or the music therapist, have not yet been investigated. The investigators therefore decided to design a prospective, randomized and controlled study to test the hypothesis that the parental (maternal and / or paternal) and / or music therapist's chant influences the well-being and / or stress of the newborn, evaluated through the parameter Heart Rate Variability (HRV), NNS development, nutritional sucking capacity, weight growth, and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation . 40 premature babies will be recruited to be divided into 4 groups, after computerized randomization: n. 3 musical groups (mother song, father song, music therapist song) and 1 control group (not subjected to musical stimulation). Infants with gestational age at birth between the 23rd and 34th week of gestation will be included. Neonates with intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) may also be enrolled. Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment. Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake.Infants who have not passed the subsequent hearing screening test using AABR (Brain Stem Automatic Response Test) will be excluded from the analysis, which is expected to be performed after reaching the correct age limit.
OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant. Evaluating how this can affect the clinical stability of the newborn (and therefore on his state of stress, measured in terms of HRV) represents a fundamental and primary point to explore, in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement. The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention (in terms of clinical stability, assessed through the HRV parameter) by the enrolled infants and to investigate any benefits of positive reinforcement obtained, through its use, on the acquisition of nutrition and growth skills of preterm infants.
Primary outcomes: clinical stability by measuring Heart Rate Variability (HRV)
- The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy (in terms of measurement of the clinical stability parameter HRV) by infants during music therapy treatment.
Secondary outcomes: effects of positive reinforcement (carried out through the use of receptive music therapy) on the acquisition of food skills and the growth of preterm infants. In particular:
- Evaluation of the achievement of exclusive oral sucking (determined as a week post-conception and / or days of life).
- Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention (measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption).
- Evaluation of the weight gain of the newborn in the 24 hours following stimulation
- (expressed as a percentage of weight gain from enrollment).
- Assessment of the growth rate from the last day of treatment to discharge.
- Length of hospital stay.
- Conditions
- Music Therapy
- Being tested
- Music therapy
- Keywords
- Music therapy, Hrv, Premature, Preterm, Music recorded receptive, Parents voice, feeding time, music therapist voice
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby
| Study group | Role | What they receive |
|---|---|---|
| Mother Recorded Receptive Music Therapy Intervention | Other | The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby Receives: Other: Music therapy |
| Fother Recorded Receptive Music Therapy Intervention | Other | The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby Receives: Other: Music therapy |
| Music therapist Recorded Receptive Music therapy intervention | Other | The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby Receives: Other: Music therapy |
| No singing | Other | The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical stability by measuring Heart Rate Variability (HRV)
Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV
Measured: 8 day
Secondary outcomes (4)
Effects of positive reinforcement carried out through the use of recorded receptive music therapy
Evaluation of the achievement of exclusive oral sucking
Measured: through study completion, an average of 20 weeks
Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills
Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention.
Measured: through study completion, an average of 20 weeks
Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants.
Evaluation of the weight gain of the newborn in the 24 hours following stimulation.
Measured: through study completion, an average of 20 weeks
Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants.
Assessment of the growth rate from the last day of treatment to discharge.
Measured: through study completion, an average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start30 Aug 2020
- Primary completion10 Feb 2021
- Study completion27 Dec 2021
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
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
- NCT04759170
- Sponsor's protocol ID
- 186
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby: Prospective Randomized Controlled Study Mom, Dad and Music Therapist Singing Voice
- ClinicalTrials.gov ID
- NCT04759170
- Acronym / sponsor ID
- 186
- Conditions
- Music Therapy
- Keywords
- Music therapy, Hrv, Premature, Preterm, Music recorded receptive, Parents voice, feeding time, music therapist voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 18 Feb 2021 (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 investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.
Detailed description
In preterm infant, oral feeding requires significant maturation of the nervous system to support coordination of the oropharyngeal muscles and breathing. Additionally, the energy expenditure required by nutritional sucking attempts further complicates the acquisition of oral feeding skills and must be balanced by caloric intake to achieve sufficient growth. Achievement of exclusive autonomous sucking typically occurs only between 34 and 36 post-conception weeks. However, delays in achieving full oral sucking are common and may prolong the infant's hospitalization.Non-nutritive sucking (NNS) is a coordinated motor skill that can be taught through an educational activity that conditions neuronal responses through positive reinforcement.The international literature demonstrates that, through a behavioral approach, the use of the pacifier during non-nutritive sucking promotes nutritional sucking in preterm infants, improving their attachment and bottle feeding, and determines the reduction of the length of stay in intensive care. and improved general well-being of the newborn.The use of receptive music therapy can therefore be supportive and represent a positive reinforcement for the development and acquisition of oral and nutritional skills of the preterm infant. By taking advantage of non-nutritive sucking it is possible to improve the suckling capacity of the newborn, his feeding speed, weight gain and consequently reduce the length of hospital stay. It is essential to achieve this result without negatively affecting the well-being and stability of the preterm infant.
Although musical studies in premature infants are limited, a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infant.On the other hand, the possible similar effects of reproduction, through the use of receptive music therapy of the song of the father and / or the music therapist, have not yet been investigated. The investigators therefore decided to design a prospective, randomized and controlled study to test the hypothesis that the parental (maternal and / or paternal) and / or music therapist's chant influences the well-being and / or stress of the newborn, evaluated through the parameter Heart Rate Variability (HRV), NNS development, nutritional sucking capacity, weight growth, and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation . 40 premature babies will be recruited to be divided into 4 groups, after computerized randomization: n. 3 musical groups (mother song, father song, music therapist song) and 1 control group (not subjected to musical stimulation). Infants with gestational age at birth between the 23rd and 34th week of gestation will be included. Neonates with intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) may also be enrolled. Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment. Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake.Infants who have not passed the subsequent hearing screening test using AABR (Brain Stem Automatic Response Test) will be excluded from the analysis, which is expected to be performed after reaching the correct age limit.
OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant. Evaluating how this can affect the clinical stability of the newborn (and therefore on his state of stress, measured in terms of HRV) represents a fundamental and primary point to explore, in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement. The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention (in terms of clinical stability, assessed through the HRV parameter) by the enrolled infants and to investigate any benefits of positive reinforcement obtained, through its use, on the acquisition of nutrition and growth skills of preterm infants.
Primary outcomes: clinical stability by measuring Heart Rate Variability (HRV)
- The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy (in terms of measurement of the clinical stability parameter HRV) by infants during music therapy treatment.
Secondary outcomes: effects of positive reinforcement (carried out through the use of receptive music therapy) on the acquisition of food skills and the growth of preterm infants. In particular:
- Evaluation of the achievement of exclusive oral sucking (determined as a week post-conception and / or days of life).
- Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention (measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption).
- Evaluation of the weight gain of the newborn in the 24 hours following stimulation
- (expressed as a percentage of weight gain from enrollment).
- Assessment of the growth rate from the last day of treatment to discharge.
- Length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mother Recorded Receptive Music Therapy Intervention | Other | Other: Music therapyThe effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby |
| Fother Recorded Receptive Music Therapy Intervention | Other | Other: Music therapyThe effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby |
| Music therapist Recorded Receptive Music therapy intervention | Other | Other: Music therapyThe effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby |
| No singing | Other | Other: Music therapyThe effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby |
Who may qualify
- Ages
- 23 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with gestational age at birth between the 23rd and 34th week of gestation
- Neonates with intraventricular hemorrhage (IVH)
- Neonates with periventricular leukomalacia (PVL)
Key exclusion criteria (4 listed)
- Only newborns in ventilatory support at the time of evaluation
- Newborns with maxillofacial malformations
- Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake
- Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term
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 |
|---|---|---|
| Music therapyThe effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby | Other | Fother Recorded Receptive Music Therapy Intervention, Mother Recorded Receptive Music Therapy Intervention, Music therapist Recorded Receptive Music therapy intervention, No singing |
Primary outcome
Clinical stability by measuring Heart Rate Variability (HRV)
Time frame: 8 day
Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV
4 secondary outcomes
Effects of positive reinforcement carried out through the use of recorded receptive music therapy
Time frame: through study completion, an average of 20 weeks
Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills
Time frame: through study completion, an average of 20 weeks
Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants.
Time frame: through study completion, an average of 20 weeks
Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants.
Time frame: through study completion, an average of 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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 Music therapy 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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical stability by measuring Heart Rate Variability (HRV) (time frame: 8 day). 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 20 Apr 2022.