The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room (kolcaba Comfor)

February 3, 2026 updated by: Fahri AŞKAN, Cukurova University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Tuşba
      • Van, Tuşba, Turkey (Türkiye), 65030
        • Yuzuncu Yıl University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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..
Other: Nursing Care Based on Kolcaba's Comfort Theory
Delivery Room Nursing Care Based on Kolcaba's Comfort Theory
No Intervention: Control group
In this study, the control group will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the starting point to at least the second hour
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.
From the starting point to at least the second hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Collaborators

Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

August 23, 2025

First Posted (Actual)

August 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASKAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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