Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT06191757
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2023-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of Early Intervention Program Applied To Premature Infants
Sponsor:
Aydin Adnan Menderes University
Organization:
Study Overview
Official Title:
Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose: This study was conducted to evaluate the effect of singing a lullaby with compassionate touch on early comfort and later on development of developmental support program in premature infants in the neonatal intensive care unit.
H01: Singing a lullaby along with touching in the early stages of premature babies in the neonatal intensive care unit has no effect on the comfort score of the babies.
H02: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the social emotional skills of premature babies.
H03: Singing lullabies with touch to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the language skills of premature babies.
H04: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the cognitive skills of premature babies.
H05: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the motor skills of premature babies.
H01: Singing a lullaby along with touching in the early stages of premature babies in the neonatal intensive care unit has no effect on the comfort score of the babies.
H02: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the social emotional skills of premature babies.
H03: Singing lullabies with touch to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the language skills of premature babies.
H04: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the cognitive skills of premature babies.
H05: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the motor skills of premature babies.
Detailed Description:
Materials and Methods: This study is a randomized controlled experimental study. The research was carried out in Aydın Adnan Menderes University Application and Research Hospital Neonatal Intensive Care Unit between 28 November 2021 and 18 July 2022. Premature infants at 330/7 -366/7 weeks of gestation who were hospitalized in the neonatal intensive care unit were included in the sampling. The sample consisted of n=57 premature infants, n=27 in the study group and n=30 in the control group. Data were collected in two stages. In the first stage, mothers sang lullabies to the infants in the study group three times a week and touched them tenderly. In the second stage, developmental support program (GEDEP) was applied to the same infants for three months starting from the 40th week of gestation. The infants in the control group were given routine care. In data collection, Mother and Newborn Descriptive Information Form, Premature Infant Comfort Scale (PICS), Developmental Support Program Evaluation Form, GEDEP user guide form and Sound Decibel Measurement Device were used. Data were evaluated with Chi-square test, Student's t-test and one-way analysis of variance, Mann-Whitney U test and Wilcoxon test. For repeated measurements, dependent groups t test and Wilcoxon signed-rank test were used.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: