Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07148570
Acronym
kolcaba Comfor
Enrollment
60
Registered
2025-08-29
Start date
2025-08-26
Completion date
2026-02-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comfort, Pain

Keywords

Kolcaba Comfort Theory, pain, Delivery room

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 Inclusion Criteria: The baby was born vaginally; the gestational age was 38 weeks or older; the baby had no congenital anomalies; the baby had a Power (1-β err prob); the baby was breathing spontaneously; the baby did not require oxygen support; the baby was a singleton; the baby had an Apgar score between 7 and 10 at the 1st and 5th minutes; The first invasive procedure was the administration of vitamin K and hepatitis B vaccine; the same researcher performed the intramuscular injection on each baby; no assistive equipment was used during birth; and the family agreed to participate in the study.

Interventions

Delivery Room Nursing Care Based on Kolcaba's Comfort Theory

Sponsors

Cukurova University
Lead SponsorOTHER
Yuzuncu Yil University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Intervention model description

Experimental, randomised controlled, single-blind study

Eligibility

Sex/Gender
ALL
Age
0 Years to 4 Years
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

Design outcomes

Primary

MeasureTime frameDescription
COMFORTneo ScaleFrom the starting point to at least the second hourThe 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 ScaleFrom the starting point to at least the second hourThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026