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

NCT06256406 | Recruiting

• 1 other identifier: 122/2022/PO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Infant Disease; Newborn Morbidity

Keywords

Newborn; Kangaroo-Mother Care Method; Music Therapy; Intensive Care Units, Neonatal

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

kangaroo care

ACTIVE COMPARATOR

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

Music therapy

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Kangaroo care method (only), Music therapy (only)

Music therapy; kangaroo care

Eligibility Criteria

• Age: 0 Days - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• newborn hospitalized in NICU

You may not qualify if:

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

Sponsors & Collaborators

• Policlinico Universitario, Catania: lead

Study Sites (1)

Neonatal intensive care unit

Catania, Sicily, 95100, Italy

RECRUITING

Related Publications (1)

• 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 RESULT

MeSH Terms

Interventions

Music Therapy; Single Person

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Central Study Contacts

Pasqua Betta, MD

CONTACT

+393396865409; mlbetta@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: February 13, 2024
• Study Start: June 20, 2022
• Primary Completion: February 29, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)