Clinical trial NCT06191757: Effect Of Early Intervention Program Applied To Premature Infants
Official title: Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Patient Comfort
Nursing Caries
Premature Infant Disease
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:Criteria for including babies in the study;

* Premature babies born as singletons at 27-0/7 - 36-6/7 weeks of gestation,
* Premature babies whose corrected age was at the 40th week of gestation (to start the developmental support program)
* Mothers could speak, read and write Turkish were included in the study.

Exclusion Criteria:The exclusion criteria for babies from the study are as follows:

* Those diagnosed with perinatal or neonatal asphyxia, those with congenital anomalies, those with Stage 3-4 intracranial or intraventricular hemorrhage,
* Those who were given sedative opioids and anticonvulsant drugs
* Whose mothers had disabilities in communication (vision, hearing, speech)

Primary outcomes:
measure: Premature Infant Comfort Scale (PICS),
timeFrame: on completion of the study ana average of 1 months
measure: GEDEP (Developmental Support Program) Evaluation Form
timeFrame: on completion of the study ana average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Funda Güler
state: Efeler
Study officials:
affiliation: study director
name: hüsniye çalışır, Prof
role: STUDY_DIRECTOR
References: