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
Verified date | January 2024 |
Source | Aydin Adnan Menderes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Funda Güler | Aydin | Efeler |
Lead Sponsor | Collaborator |
---|---|
Aydin Adnan Menderes University |
Turkey,
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 |
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