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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06232811
Other study ID # E-77082166-604.01.02-639350
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 21, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future. This research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.


Description:

At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to evaluate the bonding between themselves and their infants. Subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the Test of Sensory Functions in Infants (TSFI). The study will encompass both preterm and term-born children.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 15, 2024
Est. primary completion date November 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 12 Months
Eligibility Inclusion Criteria: preterm children with a gestational age <34 weeks Term children with a gestational age between 37 and 41 weeks Exclusion Criteria: - infants with chromosomal defects, metabolic or neuromuscular disease, - hydrocephalus, cerebral palsy, congenital heart disease,

Study Design


Intervention

Behavioral:
Assessment
Sensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated.

Locations

Country Name City State
Turkey Erzurum Technical University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mother-to-Infant Bonding Scale The Mother-to-Infant Bonding Scale is a tool designed for evaluating mother-infant bonding. Comprising 10 items on a 4-point scale, this scale yields a total score ranging from 0 to 30. Higher scores on the scale are indicative of poorer mother-to-infant bonding. 15 minutes
Primary Test of Sensory Functions in Infants The test consists of 24 items divided into five subtests: sensory processing and reactivity. subtests include: deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and vestibular stimulation. By observing the baby's response, items are scored from negative to normal according to the criteria provided; Items are given 0, 1 or 2 points depending on the baby's reaction. 30 minutes
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