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Active, not recruiting

NCT Number: NCT07834008

Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns

This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.

Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Families in the control group will receive routine nursing education provided during hospitalization. Families in the intervention group will receive a structured nursing guidance program that includes step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care.

The study will compare the two groups on maternal breastfeeding self-efficacy, perceived spousal support, perceived nursing support, parental stress, breastfeeding-related anxiety, and breastfeeding practices at hospital discharge and one month after discharge. The findings may help develop family-centered nursing interventions that enhance paternal involvement and improve breastfeeding outcomes for families with high-risk newborns.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prematurity Behavior Breast Feeding Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diarrhea Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Infant, Premature, Diseases Low Birth Weight Lung Diseases Neonatal Hyperbilirubinemia Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 235, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both parents must be 18 years of age or older.
  • Both parents must live in the same residence.
  • Both parents must be able to communicate in Mandarin Chinese or Taiwanese.
  • Their child must be a high-risk newborn admitted to the neonatal intermediate care ward for at least three days.
  • Their child must not have returned home after admission to the neonatal intermediate care ward.

Treatment and study plan

step-by-step parent education

Behavioral

Parents will receive structured, step-by-step education on breastfeeding and infant care. The education will be provided through nursing guidance, written educational materials, and instructional videos to facilitate parents' understanding and application of recommended breastfeeding and infant-care practices.

active father participation in breastfeeding support

Behavioral

Fathers will be actively involved in the breastfeeding process and infant care. They will be encouraged to provide practical, emotional, and informational support to mothers, thereby helping mothers establish and maintain breastfeeding and share responsibilities for infant care.

Primary outcomes

  1. Maternal Breastfeeding Self-Efficacy Score measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

    Time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.

    Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a 14-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores indicating greater maternal breastfeeding self-efficacy.

Secondary outcomes

  1. Maternal Perceived Spousal Support Score measured by the Spousal Parenting Support Scale

    Time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.

    Maternal perceived spousal support will be assessed using the Spousal Parenting Support Scale (maternal version), a 22-item questionnaire assessing the mother's perception of her spouse's support in parenting and caregiving. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (always). Total scores range from 22 to 110, with higher scores indicating greater perceived spousal support.

Other outcomes

  1. Maternal Perceived Nursing Staff Support Score measured by the Nursing Staff Support Scale

    Time frame: At thebaseline, pre-intervention.

    Maternal perceived nursing staff support will be assessed using the Nursing Staff Support Scale, a 21-item questionnaire assessing the support provided by nursing staff during the infant's hospitalization. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (always). Total scores range from 21 to 105, with higher scores indicating greater perceived nursing staff support.

  2. Maternal Perceived Stress Score measured by the Perceived Stress Scale

    Time frame: At thebaseline, pre-intervention, and 1 month after hospital discharge.

    Maternal perceived stress will be assessed using the Perceived Stress Scale (PSS), a 10-item self-report questionnaire. Each item is rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

The Effectiveness of Paternal Involvement in Nursing Guidance on Spousal Support and Breastfeeding Self-efficacy for Mothers of High-risk Newborns

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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