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

NCT ID: NCT06256406

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Premature Infant Disease Newborn Morbidity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study adopts a comprehensive approach to explore the effects of three interventions on the well-being and development of newborns in the Neonatal Intensive Care Unit (NICU). The interventions include optimizing the NICU environment for comfort, implementing kangaroo care for parent-infant bonding, and integrating music therapy. The research focuses on two distinct groups within the NICU: premature infants and those undergoing surgical procedures. By examining these interventions across these groups, the study aims to provide nuanced insights into enhancing the holistic care of newborns in critical care settings, tailoring approaches to the unique needs of each population.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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kangaroo care

Kangaroo care Arm subjected to Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver.

Group Type ACTIVE_COMPARATOR

in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy

Intervention Type OTHER

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.

Music therapy

Music therapy Arm subjected to music therapy, a practise improving perception of newborns

Group Type ACTIVE_COMPARATOR

in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Kangaroo care method (only) Music therapy (only)

Eligibility Criteria

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Inclusion Criteria

* newborn hospitalized in NICU

Exclusion Criteria

* not hospitalized in NICU,
* intubated infants,
* instable clinical condition
Minimum Eligible Age

0 Days

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Policlinico Universitario, Catania

OTHER

Sponsor Role lead

Responsible Party

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Pasqua Betta

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Neonatal intensive care unit

Catania, Sicily, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pasqua Betta, MD

Role: CONTACT

+393396865409

Facility Contacts

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Pasqua Betta, MD

Role: primary

+393396865409

References

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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.

Reference Type RESULT
PMID: 34444304 (View on PubMed)

Other Identifiers

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122/2022/PO

Identifier Type: -

Identifier Source: org_study_id

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