Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants

NCT07534748 | Completed DMC

• 1 other identifier: E-69996495-100-34196
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Risky Baby

Outcome Measures

Primary Outcomes (4)

• Parental Care Participation

  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.

  1 year

• Edinburgh Postnatal Depression Scale

  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.

  1 year

• State-Trait Anxiety

  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.

  1 year

• Neonatal Pain

  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.

  1 year

Secondary Outcomes (1)

• Neurological Risk Level

  1 year

Study Arms (1)

Family Care Intervention

OTHER

Other: Family Care Intervention

Interventions

Family Care Intervention OTHER

A structured, family care education was provided to parents of hospitalized neonates. The session focused on promoting parental involvement in infant care, reducing parental anxiety and depression, and minimizing neonatal pain. The intervention was delivered individually to each parent-infant dyad during hospitalization and included guidance on routine neonatal care, recognizing and responding to infant cues, and supportive strategies for high-risk infants.

Family Care Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 16, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 16, 2026

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)