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Recruiting Not applicable

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

NCT06256406 · tracked via the Priya Life Science Italy tracker
Sponsor
Policlinico Universitario, Catania
Phase
Not applicable
Started
2022-06-20
Last updated
2024-02-13

Condition(s) studied

Premature Infant DiseaseNewborn Morbidity

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
3 Years
Healthy volunteers
Accepted
Inclusion Criteria: * newborn hospitalized in NICU Exclusion Criteria: * not hospitalized in NICU, * intubated infants, * instable clinical condition

Primary outcome measure(s)

  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight — from birth to the first 3 years of life
    the effects of kangaroo care and music therapy on anthropometric parameters (weight in grams)
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2 — 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
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate — 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
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on parenting stress index — 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
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on general movements — 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 \[10-14\]).
  • Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on neurological assessment — 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.
  • levels of noise in NICU — 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

Trial sites (1)

FacilityCityRegionStatus
Neonatal intensive care unit Catania Sicily Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06256406 on ClinicalTrials.gov ↗ ← All trials in Italy