CompletedNot Applicable

The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room

Turkey (Türkiye)60 participantsStarted 2025-08-26

Plain-language summary

Newborns may experience pain, stress, and physiological changes during and after birth. Appropriate nursing care during this period can reduce negative effects by increasing the baby's comfort. Kolbaba's Comfort Theory aims to provide holistic care by supporting physical, psychological, environmental, and sociocultural comfort. This study aims to investigate the effects of nursing interventions based on Kolcaba's theory on pain, comfort, crying duration, and physiological parameters (heart rate, respiratory rate, SpO₂, body temperature, etc.) in noenates delivered vaginally. The findings aim to reveal the contribution of comfort-focused approaches in noenates care to clinical outcomes.

Who can participate

Age range0 Hours – 4 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Vaginal delivery newborns in the delivery room * Spontaneous vaginal delivery * Stable condition (APGAR ≥7 at 5 minutes) * No congenital anomalies * Gestational age ≥37 weeks * Birth weight ≥2500g * No maternal sedation/analgesia in last 4 hours * No neonatal resuscitation required Exclusion Criteria: * Preterm infants (\<37 weeks) * Maternal fever (\>38°C) or chorioamnionitis * Major congenital anomalies * Need for NICU admission * Maternal general anesthesia

What they're measuring

COMFORTneo Scale

Timeframe: From the starting point to at least the second hour

Neonatal Pain Scale

Timeframe: From the starting point to at least the second hour

Trial details

NCT IDNCT07148570

SponsorCukurova University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-30

View on ClinicalTrials.gov More Comfort trials