ClinicalTrials.Veeva

Menu

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

Ç

Çukurova University

Status

Completed

Conditions

Comfort
Pain

Treatments

Other: Nursing Care Based on Kolcaba's Comfort Theory

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

Under 4 hours old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

fahri askan, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems