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

July 25, 2025 updated by: Fahri AŞKAN, Cukurova University

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

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
    • tATATVAN/BİTLİS
      • Bi̇tli̇s, tATATVAN/BİTLİS, Turkey, 13200
        • Tatvan Devlet Hastanesi

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:

  • Newborns with suspected or diagnosed sepsis
  • Avoiding the use of analgesic, sedative or muscle relaxant drugs that may affect comfort.
  • No congenital anomalies,
  • Birth weight over 1500 grams,
  • No need for mechanical ventilation,
  • Vital signs are stable,
  • Hospitalization of babies in the first 48 hours after birth,
  • Newborn babies whose babies are deemed stable by the neonatologist will be included in the study.
  • No hyperbilirubinemia requiring exchange transfusion,
  • Those who do not have intrauterine infection (rubella, syphilis, toxoplasma) will be included in the study.

Exclusion Criteria:

  • Newborns with sepsis or suspected sepsis
  • Analgesic, sedative or muscle relaxant medication that may affect comfort is given,
  • Enteral-fed infants,
  • Having a congenital anomaly,
  • Birth weight below 1500 grams,
  • Those who require mechanical ventilation,
  • Vital signs are unstable,
  • Babies who are not hospitalized in the first 48 hours after birth,
  • Newborn babies whose babies are not deemed stable by the neonatologist will not be included in the study.
  • Those with hyperbilirubinemia requiring exchange transfusion,
  • Those with intrauterine infection (rubella, syphilis, toxoplasma) will not be included in the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
In this study, the control group will receive standard care.
Experimental: Experimental Group
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.
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.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Infant Pain Scale-Nips
Time Frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
The scale developed by Lawrence et al. is used for premature and newborns. In the neonatal pain scale, 5 (five) behavioral groupings (facial expression, crying, movements of arms and legs, state of wakefulness) and a physiological parameter (respiratory pattern) are evaluated and measured. Total score varies between 0-7. A high score on this scale indicates that the intensity of the pain is high. .
It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Newborn Comfort Behavior Scale
Time Frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
It is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. M. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (YKDS) is 6 and the highest score is 30. If the total score of the scale is between 14-30, it is emphasized that the baby is in pain or distress, is uncomfortable and needs interventions to provide comfort. Scoring 4-6 on the Numerical Rating Scales indicates moderate pain and distress, while scoring 7-10 indicates severe pain and distress.
It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.

Collaborators and Investigators

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

Sponsor

Cukurova 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)

July 26, 2024

Primary Completion (Actual)

July 2, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fahri Aşkan

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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