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Recruiting NCT06256406

Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit

No phase Interventional Premature Infant Disease Newborn Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy.
Who it may be relevant to
Registry conditions: Premature Infant Disease, Newborn Morbidity. Basic parameters: 0 Days — 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress

Overview

Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU). These strategies not only contribute to the physical well-being of the infants but also play a significant role in promoting their emotional and developmental health.

Detailed description

The well-being of newborns in the Neonatal Intensive Care Unit (NICU) is paramount, and establishing a comfortable environment is a fundamental aspect of their care. This involves controlling factors such as temperature, lighting, and noise to mimic the conditions of the womb, creating a soothing and supportive atmosphere for their fragile development. A calm environment is essential for premature infants, as it can contribute to improved weight gain, better sleep patterns, and overall physiological stability.

Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver, has proven to be a transformative intervention in NICU settings. This method not only fosters the bond between the baby and their parent but also offers numerous physiological benefits. Kangaroo care has been associated with stabilized heart and respiratory rates, enhanced weight gain, and improved neurodevelopmental outcomes. The close physical contact provides a sense of security and comfort, mimicking the warmth and safety of the mother's womb.

Incorporating music therapy into the care routine of NICU infants has demonstrated positive effects on their well-being. Music has the power to reduce stress, stabilize vital signs, and promote better sleep patterns. Live or recorded lullabies, specifically designed for preterm infants, have been shown to have a calming influence and aid in the regulation of physiological functions. Additionally, music therapy can serve as a valuable tool for parents, offering a means of bonding with their hospitalized newborns and alleviating the stress associated with the NICU experience.

In conclusion, the utility of a comfortable environment, kangaroo care, and music therapy for newborns in the NICU extends beyond basic medical care. These interventions recognize the holistic needs of premature or ill infants, addressing both their physical and emotional requirements. By prioritizing a nurturing and supportive environment, healthcare providers aim to optimize the developmental trajectory of these vulnerable newborns, fostering better outcomes for their long-term health and well-being.

Interventions

  • Other in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
    Kangaroo care is a practice involving skin-to-skin contact between the infant and a caregiver,. Music therapy is a therapeutic approach that utilizes the expressive and emotional qualities of music to address physical, emotional, cognitive needs of individuals.

Primary outcome measures

  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight [Time frame: from birth to the first 3 years of life]
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2 [Time frame: from birth to the first 3 years of life]
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate [Time frame: from birth to the first 3 years of life]
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on parenting stress index [Time frame: from birth to the first 3 years of life]
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on general movements [Time frame: from birth to the first 3 years of life]
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on neurological assessment [Time frame: from birth to the first 3 years of life]
  • levels of noise in NICU [Time frame: from birth to the first 3 years of life]

Eligibility criteria

Inclusion criteria

  • newborn hospitalized in NICU

Exclusion criteria

  • not hospitalized in NICU,
  • intubated infants,
  • instable clinical condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • Neonatal intensive care unit — Catania

Publications

  • Bieleninik L, Ettenberger M, Epstein S, Elefant C, Arnon S. Potential Psychological and Biological Mechanisms Underlying the Effectiveness of Neonatal Music Therapy during Kangaroo Mother Care for Preterm Infants and Their Parents. Int J Environ Res Public Health. 2021 Aug 13;18(16):8557. doi: 10.3390/ijerph18168557. PMID 34444304

Identifiers

NCT: NCT06256406 · 122/2022/PO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗