Clinical trial NCT06491641: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Comfort, Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Comfort Theory
Hemodynamic Variables
Keywords: pain
Comfort
Hemodynamic Variables
Kolcaba's Comfort Theory
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomised controlled, single-blind study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Neonates with or without suspicion of 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,
* 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.

Primary outcomes:
measure: Neonatal Infant Pain Scale-Nips
timeFrame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
measure: Newborn Comfort Behavior Scale
timeFrame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Bi̇tli̇s
country: Turkey
facility: Tatvan Devlet Hastanesi
state: tATATVAN/BİTLİS
Study officials:
References: