The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Pain, Comfort, and Physiological Parameters in Newborns Delivered Vaginally in the Delivery Room
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- COMFORTneo Scale
Study Overview
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.
Detailed Description
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.
Kolcaban's Comfort Theory for Care in the Delivery Room
Intervention Group:
1. Physical sub-dimension; 2. Psychospiritual comfort sub-dimension: White noise playback; skin-to-skin contact; gentle touch; 3. Sociocultural comfort sub-dimension: Family-centered care (providing contact with parents), respect for cultural practices; 4. Care will be provided in accordance with the Environmental Comfort sub-dimension..
Research Population and Sample: The study will be conducted on newborns born vaginally in the maternity ward and whose parents are eligible and agree to participate in the study. Sample: This study will be conducted on newborns selected on a voluntary basis, meeting the inclusion criteria, gestational age 38-42 weeks, 2500-4000 g, and an Apgar score ≥7. Sample Size: The number determined by power analysis, e.g., 60 infants (30 experimental, 30 control).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 0 Hours to 4 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental: Participant group
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..
Intervention: Nursing Care Based on Kolcaba's Comfort Theory (Other)
Control group
In this study, the control group will receive standard care
Outcomes
Primary Outcomes
COMFORTneo Scale
Time Frame: From the starting point to at least the second hour
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).
Neonatal Pain Scale
Time Frame: From the starting point to at least the second hour
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Fahri AŞKAN
Assistant Professor
Cukurova University