Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06256406

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Premature Infant Disease Newborn Morbidity

Age range

0 day–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal intensive care unit

Catania, Sicily, 95100, Italy

Location status: Recruiting

Location contact

Pasqua Betta, MD

CONTACT

[email protected]

+393396865409

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newborn hospitalized in NICU

Exclusion criteria

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

Treatment and study plan

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

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.

Other names: Kangaroo care method (only), Music therapy (only)

Primary outcomes

  1. 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

    the effects of kangaroo care and music therapy on anthropometric parameters (weight in grams)

  2. 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

    the effects of kangaroo care and music therapy on vital signs: saturation in percentage of SpO2

  3. 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

    the effects of kangaroo care and music therapy on vital signs: heart rate in beats for minutes

  4. 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

    the effects of kangaroo care and music therapy on scales: Parenting stress index.

    Subscales:1) Parental Distress (PD): personal factors directly related to parenting; 2) Difficult Child (DC): temperament and behavior of the child that influence the parent-child relationship; 3) Parent-Child Dysfunctional Interactions (P-CDI): parent's perception of the child; whether or not expectations are being met, positive behaviors reinforced, etc.

    Assessment Characteristics:36 items Minimum/Maximum Scores: 1) 12 - 60 in each subscale, 2) 36 - 180 total stress score Higher score showed more levels of stress

  5. 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

    the effects of kangaroo care and music therapy on scales: General movement optimality scores (GMOS) It differentiated between normal general movements (median 39 [25-75th centile 37-41]), poor repertoire general movements (median 25 [22-29]), cramped-synchronized general movements (median 12 [10-14]).

  6. 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

    the effects of kangaroo care and music therapy on scales: Hammersmith Neurological Examination (HNE) HNE assess motor function and overall neurological status. The HNE includes two components: the Hammersmith Functional Motor Scale (HFMS) and the Hammersmith Spinal Muscular Atrophy Functional Rating Scale (HSMARS).

    It is scored on a scale ranging from 0 to 66, with higher scores indicating better motor function.

  7. levels of noise in NICU

    Time frame: from birth to the first 3 years of life

    levels of noise in NICU (assessed as sound pressure levels measured using a dosimeter) in dBA. highter dBA corresponded to more noise

Study contacts

Contact information is provided by the study sponsor or research team.

Pasqua Betta, MD

CONTACT

[email protected]

+393396865409

Sponsors and collaborators

Lead sponsor

Policlinico Universitario, Catania

Other

Registry information

Official study title

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

Acronym: PRE-CARE

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.