Back to resultsEffect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Primary Purpose
Premature Infant
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
online education program
no online education program
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Infant focused on measuring Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
Eligibility Criteria
Inclusion Criteria:
- infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
- Being a premature baby born at or under 32 weeks
- infant corrected age between 0-8 months
- To agree to participate in the study.
Exclusion Criteria:
- Having a concomitant major anomaly and genetic disease
- The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study group
Control group
Arm Description
Parents of premature infants in the experimental group received online education consist of information to support infants motor,social-communication development.and to manage the parents stress.
The parents of premature babies in the control group did not receive any education programs
Outcomes
Primary Outcome Measures
Alberta Infant Motor Scale (AIMS)
AIMS assesses the gross infant motor skills in supine, prone, sitting and standing positions with 58 items.the child is scored dec 0 to 58 points and evaluated with age-appropriate percentile curves:0-10 atypical development, 11-25 questionable performance, 26-75 normal performance, 76-90 very good performance, 91-100 are classified as excellent performance.
The Social-Communication Area Screening Test of İnfant (SCASI)
SCASI assesses the social-communication infant skills,filled by the parents.it is an original and fast test for the early identification and evaluation of children at developmental risk in infancy and early childhood up to the age of 6-24 months.
Secondary Outcome Measures
Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfonctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05410639
Brief Title
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Official Title
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
March 17, 2021 (Actual)
Study Completion Date
March 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.
Detailed Description
Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant
Keywords
Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Parents of premature infants in the experimental group received online education consist of information to support infants motor,social-communication development.and to manage the parents stress.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The parents of premature babies in the control group did not receive any education programs
Intervention Type
Other
Intervention Name(s)
online education program
Intervention Description
The training we provided was to give exercises and advice to parents according to the age of the baby in order to stimulate the motor and social development of the baby,and then, an improvement in the stress state of the parents by their participation in the care of their baby.The training, which began with the discharge of the baby from the hospital, was in the form of slide presentations and videos.
Intervention Type
Other
Intervention Name(s)
no online education program
Intervention Description
Parents and their infants in the control group did not receive any online education program
Primary Outcome Measure Information:
Title
Alberta Infant Motor Scale (AIMS)
Description
AIMS assesses the gross infant motor skills in supine, prone, sitting and standing positions with 58 items.the child is scored dec 0 to 58 points and evaluated with age-appropriate percentile curves:0-10 atypical development, 11-25 questionable performance, 26-75 normal performance, 76-90 very good performance, 91-100 are classified as excellent performance.
Time Frame
Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
Title
The Social-Communication Area Screening Test of İnfant (SCASI)
Description
SCASI assesses the social-communication infant skills,filled by the parents.it is an original and fast test for the early identification and evaluation of children at developmental risk in infancy and early childhood up to the age of 6-24 months.
Time Frame
Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
Secondary Outcome Measure Information:
Title
Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
Description
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfonctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.
Time Frame
Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
Being a premature baby born at or under 32 weeks
infant corrected age between 0-8 months
To agree to participate in the study.
Exclusion Criteria:
Having a concomitant major anomaly and genetic disease
The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaoula Ben Kilani
Organizational Affiliation
Bachelor study principal invistigator Marmara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gönül Acar
Organizational Affiliation
Assoc.Prof.
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
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