Effect Of Early Intervention Program Applied To Premature Infants

NCT ID: NCT06191757

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-28
• Study Completion Date: 2023-07-18

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

experimental group

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.

Group Type: EXPERIMENTAL

supported with the developmental support program

Intervention Type: BEHAVIORAL

Babies were developmentally supported with the developmental support program

control group

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.

Group Type: EXPERIMENTAL

supported with the developmental support program

Intervention Type: BEHAVIORAL

Babies were developmentally supported with the developmental support program

Interventions

supported with the developmental support program

Babies were developmentally supported with the developmental support program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

funda güler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hüsniye çalışır, Prof

Role: STUDY_DIRECTOR

study director

Locations

Funda Güler

Aydin, Efeler, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AydınAdnanMenderesUniversıty

Identifier Type: -

Identifier Source: org_study_id