- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06191757
Effect Of Early Intervention Program Applied To Premature Infants
Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Efeler
-
Aydın, Efeler, Turkey, 0900
- Funda Güler
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Babies were developmentally supported with the developmental support program
|
Experimental: 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:
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. |
Babies were developmentally supported with the developmental support program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
on completion of the study ana average of 1 months
|
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.
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on completion of the study ana average of 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: hüsniye çalışır, Prof, Study Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AydınAdnanMenderesUniversıty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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