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Completed

NCT Number: NCT06191757

Effect Of Early Intervention Program Applied To Premature Infants

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.

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Key information

Conditions

Infant Development Nursing Caries Patient Comfort Premature Infant Disease

Age range

1 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Funda Güler

Aydin, Efeler, 0900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

supported with the developmental support program

Behavioral

Babies were developmentally supported with the developmental support program

Primary outcomes

  1. Premature Infant Comfort Scale (PICS),

    Time frame: on completion of the study ana average of 1 months

    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

  2. GEDEP (Developmental Support Program) Evaluation Form

    Time frame: on completion of the study ana average of 3 months

    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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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