Effect Of Early Intervention Program Applied To Premature Infants

Infant Development Clinical Trial

Official title:

Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06191757
• Other study ID #: AydinAdnanMenderesUniversity
• Status: Completed
• Phase: N/A
• Start date: November 28, 2021
• Est. completion date: July 18, 2023

Study information

• Verified date: January 2024
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 3 Months

Eligibility

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)

Related Conditions & MeSH terms

• Infant Development
• Infant, Premature, Diseases
• Nursing Caries
• Patient Comfort
• Premature Birth
• Premature Infant Disease

Intervention

Behavioral:
• supported with the developmental support program
Babies were developmentally supported with the developmental support program

Locations

Country	Name	City	State
Turkey	Funda Güler	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Infant Comfort Scale (PICS),	PICS is a tool that multidimensionally evaluates the behavioral and psychological comfort and pain level of babies. In PBCS, Awakeness, Calmness/Agitation, Respiratory Status (only for those with mechanical ventilation support) or Crying (only for children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate are used to evaluate the baby's comfort level. Seven parameters are used. The scale is a 5-point Likert type scale where each parameter can be scored between 1 (bad) and 5 (good). According to PICS, the baby's comfort is evaluated based on the total score. The highest comfort score of 35 represents the lowest comfort score of 7. The total score determined as the cut-off value of the scale is 17. Babies with a total score of 17 or higher are considered cutoff for comfort level and indicate a need for pain-reducing interventions	on completion of the study ana average of 1 months
Primary	GEDEP (Developmental Support Program) Evaluation Form	It aims to provide a rough assessment of children's cognitive, language/communication, motor, social-emotional and self-care skills in the 0-36 month period. This form contains introductory information such as the child's name, surname, date of birth, age, diagnosis, and parents' names. At the same time, skills in developmental areas included in GEDEP are also included in the form. Skills marked as "cannot do" and/or "partially able" on the form indicate the skills that the child needs to be worked on using GEDEP.	on completion of the study ana average of 3 months