Effect Of Early Intervention Program Applied To Premature Infants

Aydin Adnan Menderes University

Status: Completed

Conditions: Patient Comfort; Premature Infant Disease; Infant Development; Nursing Caries

Treatments: Behavioral: supported with the developmental support program

Study type: Interventional

Funder types: Other

Identifiers

NCT06191757

AydınAdnanMenderesUniversıty

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: supported with the developmental support program

control group

Experimental group

Description:

The data of the control group were collected in two stages. No intervention was made to the control group by the researcher. First stage application steps: * Before starting the application, the Mother and Newborn Information Form (Annex 1) was filled out by the researcher. * The babies in the control group were cared for and their daily care (hygienic care (oral care, eye care, body care, diaper cleaning, etc.), feeding, taking vital signs, other follow-ups) were carried out by the nurse. Approximately 10-15 minutes and 20-25 minutes after the care was completed, the baby's responses were evaluated by the researcher with the premature comfort scale. Second stage: When the babies in the control group reached their first corrected month, developmental evaluations were made by the researcher using the GEDEP evaluation form every four weeks for a total of three months.

Treatment:

Behavioral: supported with the developmental support program