Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites

June 5, 2022 updated by: Marmara University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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.
Other: online education program
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.
Placebo Comparator: Control group
The parents of premature babies in the control group did not receive any education programs
Other: no online education program
Parents and their infants in the control group did not receive any online education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alberta Infant Motor Scale (AIMS)
Time Frame: Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
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.
Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
The Social-Communication Area Screening Test of İnfant (SCASI)
Time Frame: Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
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.
Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
Time Frame: Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
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.
Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Khaoula Ben Kilani, Bachelor study principal invistigator Marmara University
  • Study Chair: Gönül Acar, Assoc.Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Actual)

March 17, 2021

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

June 5, 2022

First Submitted That Met QC Criteria

June 5, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 5, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2020.1352

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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