跳至主要内容
临床试验/NCT06256406
NCT06256406招募中不适用

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

Policlinico Universitario, Catania2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
0 Days 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • newborn hospitalized in NICU

排除标准

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

结局指标

主要结局

Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2

时间窗: 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 parenting stress index

时间窗: 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

时间窗: 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 \[10-14\]).

levels of noise in NICU

时间窗: 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

Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight

时间窗: 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 neurological assessment

时间窗: 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.

Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Policlinico Universitario, Catania
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pasqua Betta

Principal investigator

Policlinico Universitario, Catania

研究点 (2)

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