Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491641
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-26
Brief Title:
The Effect of Nursing Care Based on Kolcabas Comfort Theory on the Newborn
Sponsor:
Cukurova University
Organization:
Cukurova University
Study Overview
Official Title:
The Effect of Nursing Care Based on Kolcabas Comfort Theory on Comfort Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It was planned to determine the effect of nursing care based on Kolcabas 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
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 hisher 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-3194 program at the studys reliability coefficient of α005 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 0816 and the minimum sample size to be 0816 intervention with a theoretical power of 085 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
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-3194 program at the studys reliability coefficient of α005 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 0816 and the minimum sample size to be 0816 intervention with a theoretical power of 085 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None