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

NCT07148570 | Completed DMC

• 1 other identifier: FASKAN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Comfort

Keywords

Kolcaba Comfort Theory; pain; Delivery room

Outcome Measures

Primary Outcomes (2)

• COMFORTneo Scale

  The COMFORTneo scale is a validated Likert-type tool assessing neonatal comfort, pain, and distress through six behavioral parameters (facial tension, muscle tone, crying, alertness, calmness/agitation, respiratory response, and body movements). Scores range from 6 (optimal comfort) to 30 (severe distress), with 4-6 indicating moderate and 7-10 severe pain/distress (van Dijk et al., 2005).

  From the starting point to at least the second hour

• Neonatal Pain Scale

  The NIPS uses 1 physiological (respiratory pattern) and 5 behavioral parameters (crying, alertness, facial expression, arm/leg movements) to assess pain in newborns. The scale is scored from 0 to 7, with higher scores indicating severe pain.

  From the starting point to at least the second hour

Study Arms (2)

Experimental: Participant group

EXPERIMENTAL

During the implementation process, neonates in the experimental group will receive care in line with Kolcaba's comfort theory throughout their stay in the intensive care unit..

Other: Nursing Care Based on Kolcaba's Comfort Theory

Control group

NO INTERVENTION

In this study, the control group will receive standard care

Interventions

Nursing Care Based on Kolcaba's Comfort Theory OTHER

Delivery Room Nursing Care Based on Kolcaba's Comfort Theory

Experimental: Participant group

Eligibility Criteria

• Age: 0 Hours - 4 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Preterm infants (\<37 weeks)
• Maternal fever (\>38°C) or chorioamnionitis
• Major congenital anomalies
• Need for NICU admission
• Maternal general anesthesia

Sponsors & Collaborators

• Cukurova University: lead
• Yuzuncu Yil University: collaborator

Study Sites (1)

Yuzuncu Yıl University

Van, Tuşba, 65030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental, randomised controlled, single-blind study

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 29, 2025
• Study Start: August 26, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

TU (1)