The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn
NCT ID: NCT06491641
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2024-07-26
2025-07-02
Brief Summary
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* 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?
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
Control Group
In this study, the control group will receive standard care.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Hour
28 Days
ALL
Yes
Sponsors
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Cukurova University
OTHER
Responsible Party
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Fahri AŞKAN
Assistant Professor
Locations
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Tatvan Devlet Hastanesi
Bitlis, tATATVAN/BİTLİS, Turkey (Türkiye)
Countries
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Other Identifiers
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Fahri Aşkan
Identifier Type: -
Identifier Source: org_study_id
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