NCT06491641

The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn

The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Comfort, Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Accepted

Summary

It was planned to determine the effect of nursing care based on Kolcaba's Comfort Theory on newborns' comfort, pain and hemodynamic variables for babies admitted to the neonatal intensive care unit. * Does nursing care based on comfort theory reduce the comfort and pain levels of newborn babies? * Does nursing care based on comfort theory have an effect on babies' vital signs?

Detailed description

Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems." The concept of comfort has been frequently used in neonatal intensive care units (NICU) and newborn babies in recent years. Unlike intrauterine life, NICU is an environment for newborn babies where there is noisy, cool, bright, dry, heat and light conditions are not good, and the baby has difficulty in making movements due to the power of gravity. The physical structure of intensive care units (NICU), the anatomical and physiological immaturity of newborn babies, frequent routine care and invasive procedures may cause babies to lose their comfort. This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery. The sample size of the study was determined using power analysis. The power of the research is defined as the possibility of revealing the difference between two applications. A study must have at least 80% power. It was calculated using the G. Power-3.1.9.4 program at the study's reliability coefficient of α=0.05 and 85% confidence level. In their study titled "The effect of the comfort care model on distress, pain and hemodynamic parameters in infants after congenital heart defect surgery", they found the effect size to be 0.816 and the minimum sample size to be 0.816. intervention with a theoretical power of 0.85. A total of 56 individuals will be included, 28 in the control group and 28 in the control group. Considering data loss, the study will be conducted with a total of 60 newborns, 30 newborns in each group.

Conditions

• Pain
• Comfort Theory
• Hemodynamic Variables

Interventions

Type	Name	Description
OTHER	Care based on Kolcaba's comfort theory	During the application process, the babies in the experimental group will receive care based on Kolcaba's comfort theory during their stay in intensive care.

Timeline

• Start date: 2024-07-26
• Primary completion: 2025-07-02
• Completion: 2025-07-02
• First posted: 2024-07-09
• Last updated: 2025-07-29

Locations

1 site across 1 country: Turkey (Türkiye)