Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit (PRE-CARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Newborn Morbidity; Premature Infant Disease
• Intervention / Treatment: Other: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pasqua Betta, MD; Phone Number: +393396865409; Email: mlbetta@yahoo.it

Study Locations

• Italy
  • Sicily
    • Catania, Sicily, Italy, 95100
      • Recruiting
      • Neonatal intensive care unit
      • Contact: Pasqua Betta, MD; Phone Number: +393396865409; Email: mlbetta@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• newborn hospitalized in NICU

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: kangaroo care; Kangaroo care Arm subjected to Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver.	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.; Other Names: Kangaroo care method (only); Music therapy (only)
Active Comparator: Music therapy; Music therapy Arm subjected to music therapy, a practise improving perception of newborns	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.; Other Names: Kangaroo care method (only); Music therapy (only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight	the effects of kangaroo care and music therapy on anthropometric parameters (weight in grams)	from birth to the first 3 years of life
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2	the effects of kangaroo care and music therapy on vital signs: saturation in percentage of SpO2	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	the effects of kangaroo care and music therapy on vital signs: heart rate in beats for minutes	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	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	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	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]).	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	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.	from birth to the first 3 years of life
levels of noise in NICU	levels of noise in NICU (assessed as sound pressure levels measured using a dosimeter) in dBA. highter dBA corresponded to more noise	from birth to the first 3 years of life

Collaborators and Investigators

• Sponsor: Policlinico Universitario, Catania

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Newborn; Music Therapy; Kangaroo-Mother Care Method; Intensive Care Units, Neonatal
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: 122/2022/PO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: newborns meeting predefined inclusion and exclusion criteria will be enrolled to evaluate the impact of environmental noise, kangaroo care, and music therapy during their hospitalization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No