Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-01-14 @ 6:02 AM
Study NCT ID:
NCT06256406
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}, {'id': 'D012847', 'term': 'Single Person'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-04', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on weight', 'timeFrame': 'from birth to the first 3 years of life', 'description': 'the effects of kangaroo care and music therapy on anthropometric parameters (weight in grams)'}, {'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on SpO2', 'timeFrame': 'from birth to the first 3 years of life', 'description': 'the effects of kangaroo care and music therapy on vital signs: saturation in percentage of SpO2'}, {'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on heart rate', 'timeFrame': 'from birth to the first 3 years of life', 'description': 'the effects of kangaroo care and music therapy on vital signs: heart rate in beats for minutes'}, {'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on parenting stress index', 'timeFrame': 'from birth to the first 3 years of life', 'description': "the effects of kangaroo care and music therapy on scales: Parenting stress index.\n\nSubscales: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.\n\nAssessment 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"}, {'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on general movements', 'timeFrame': 'from birth to the first 3 years of life', 'description': '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\\]).'}, {'measure': 'Efficacy of kangaroo care and music therapy in premature infants and surgical newborns on neurological assessment', 'timeFrame': 'from birth to the first 3 years of life', 'description': '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).\n\nIt is scored on a scale ranging from 0 to 66, with higher scores indicating better motor function.'}, {'measure': 'levels of noise in NICU', 'timeFrame': 'from birth to the first 3 years of life', 'description': 'levels of noise in NICU (assessed as sound pressure levels measured using a dosimeter) in dBA. highter dBA corresponded to more noise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Newborn', 'Kangaroo-Mother Care Method', 'Music Therapy', 'Intensive Care Units, Neonatal'], 'conditions': ['Premature Infant Disease', 'Newborn Morbidity']}, 'referencesModule': {'references': [{'pmid': '34444304', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nKangaroo 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.\n\nIncorporating 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborn hospitalized in NICU\n\nExclusion Criteria:\n\n* not hospitalized in NICU,\n* intubated infants,\n* instable clinical condition'}, 'identificationModule': {'nctId': 'NCT06256406', 'acronym': 'PRE-CARE', 'briefTitle': 'Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Universitario, Catania'}, 'officialTitle': "Comparative Evaluation Between Preterms and Newborns Undergoing Surgery. Effectiveness of a Multimodal Sensory Intervention on Newborns and Parents' Stress", 'orgStudyIdInfo': {'id': '122/2022/PO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'kangaroo care', 'description': 'Kangaroo care Arm subjected to Kangaroo care, a practice involving skin-to-skin contact between the infant and a caregiver.', 'interventionNames': ['Other: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music therapy', 'description': 'Music therapy Arm subjected to music therapy, a practise improving perception of newborns', 'interventionNames': ['Other: in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy']}], 'interventions': [{'name': 'in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy', 'type': 'OTHER', 'otherNames': ['Kangaroo care method (only)', 'Music therapy (only)'], 'description': '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.', 'armGroupLabels': ['Music therapy', 'kangaroo care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Catania', 'state': 'Sicily', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasqua Betta, MD', 'role': 'CONTACT', 'email': 'mlbetta@yahoo.it', 'phone': '+393396865409'}], 'facility': 'Neonatal intensive care unit', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Pasqua Betta, MD', 'role': 'CONTACT', 'email': 'mlbetta@yahoo.it', 'phone': '+393396865409'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Universitario, Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Pasqua Betta', 'investigatorAffiliation': 'Policlinico Universitario, Catania'}}}}