An interventional study of Care based on Kolcaba's comfort theory in Pain, Comfort Theory and Hemodynamic Variables, sponsored by Cukurova University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Hour to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 62 is below the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
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
In this study, the control group will receive standard care.
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.
Also known as: Control Group
Neonatal Infant Pain Scale-Nips
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. .
Time frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Newborn Comfort Behavior Scale
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.
Time frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Plan to share: Undecided
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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