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

NCT05410639 | Completed DMC

• 1 other identifier: 09.2020.1352
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Keywords

Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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 Outcomes (1)

• Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)

  Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

The parents of premature babies in the control group did not receive any education programs

Other: no online education program

Interventions

online education program OTHER

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.

Study group

no online education program OTHER

Parents and their infants in the control group did not receive any online education program

Control group

Eligibility Criteria

• Age: 0 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Khaoula Ben Kilani

  Bachelor study principal invistigator Marmara University

  PRINCIPAL INVESTIGATOR

• Gönül Acar

  Assoc.Prof.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: February 24, 2021
• Primary Completion: March 17, 2021
• Study Completion: March 18, 2022
• Last Updated: June 8, 2022

Record last verified: 2021-12

Locations

TU (1)