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Clinical Trials/NCT07534748
NCT07534748
Completed
Not Applicable

Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention

Inonu University1 site in 1 country34 target enrollmentStarted: January 1, 2024Last updated:
ConditionsRisky Baby

Overview

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Parental Care Participation

Overview

Brief Summary

This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.

All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Infants diagnosed as neurodevelopmentally at risk.
  • Infants born between 37 and 40 gestational weeks.
  • Infants with a birth weight below 2500 grams.
  • Infants who have been admitted to the neonatal intensive care unit for at least 10 days since birth.

Exclusion Criteria

  • Infants whose families declined participation in the study.
  • Infants with congenital anomalies.

Arms & Interventions

Family Care Intervention

Other

Intervention: Family Care Intervention (Other)

Outcomes

Primary Outcomes

Parental Care Participation

Time Frame: 1 year

In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.

Edinburgh Postnatal Depression Scale

Time Frame: 1 year

In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.

State-Trait Anxiety

Time Frame: 1 year

In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.

Neonatal Pain

Time Frame: 1 year

In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.

Secondary Outcomes

  • Neurological Risk Level(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Müşerref Ebru YALÇIN

Principal Investigator

Inonu University

Study Sites (1)

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