Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04478162
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2020-06-27
Brief Title:
The Effect of Family Integrated Care on Preparing Parents With Premature Infants Hospitalized in the Neonatal Intensive Care Unit for Discharge
Sponsor:
Sakarya University
Organization:
Sakarya University
Study Overview
Official Title:
Investigation of the Effect of Family Integrated Care Method on Preparedness for Discharge
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Physiological and structural features of premature infants differ from mature newborns Families worry about touching their very sensitive and fragile babies which are quite different from their expectations and they seriously concern about how they will take care of their babies who are cared for by the specialist staff at the hospital when they are discharged to home Different approaches and models are applied in the Neonatal Intensive Care Units NICU to prepare families especially mothers for the discharge process and to overcome these fears of the parents However most of the time investigators observe in both researches and units that these approaches are not efficient In this study which investigators started with the questions as What can investigators do better in this issue and How can investigators help families more in this process investigator have seen that Family Integrated Care FICare model is applied in some clinics abroad and successful results have been obtained However investigators did not come across a study that applied this model and examined the effect of it on parents on being ready for discharge Since this study will be a first in terms of both this aspect and the application of this model in our country in this unique study investigators aim to draw attention to this approach in our country also contribute to keeping the premature babies healthy
Research Hypotheses
H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group
H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group
H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group
Research Hypotheses
H0 There is no difference between the readiness for discharge of mothers and fathers included in the FICare model compared to the control group
H1 The hypothesis of this study is that the mothers included in the FICare model have higher levels of discharge readiness than the control group
H2 The hypothesis of this study is that the fathers included in the FICare model have higher levels of discharge readiness than the control group
Detailed Description:
Background The Family Integrated Care FICare model is a modern approach that supports the participation of parents excluding ventilation monitor adjustments vascular fluid and drug administration developed in collaboration between parents and healthcare professionals which is carried out gradually in the NICU 1 Parents are informed about the general development of the baby brain and sensory development motor and behavior development care of the premature In addition parents are informed about what they can do about general body cleaning and care especially in touch attachment skin-to-skin contact breastfeeding and increased breast milk and diaper change 2FICare It is a care model with a 25 increase in the weight gain of premature babies a 80 increase in breastfeeding rate a 25 decrease in parental stress a significant decrease in critical incident reports such as hospital infection and sudden infant death 3 The care that these babies receive in their first hours days weeks and months is vital to determine their future health and long-term outcomes Evidence suggests that if parents are supported and encouraged to take care of their babies while in hospital this will have better outcomes for both the baby and their family FICare support not only reduces the length of hospital stay of parents but also reduces the rate of re-hospitalization and strengthens the bond between parents and babies It helps parents feel safer when taking care of their babies both in the hospital and at home 4
A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit With the FICare model it is thought that parents will be prepared for discharge bonding between parents and babies fulfilling their parental roles supporting babies breastfeeding reducing hospital stay enhancing parental-employee communication and increasing the quality of care services
Premature infants who were hospitalized for at least seven days between February 6 2020 and August 15 2021 in the NICU of a training and research hospital formed the population of the study In the study the total number of parents was determined as 68 when the margin of error was 5 the power level was 8117 and the effect size value was 070 At the end of the study a post hoc power analysis was conducted to determine the adequacy of the sample size As a result of the power analysis for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit type 1 error 005 n 68 people effect size 1990 and the power level according to the structure was determined as 1000 To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit type 1 error 005 n 68 people effect size 2586 and power level according to temperature was determined as 1000 These values show that the sample size is sufficient
A standard care model for discharge preparation is not applied to parents who have a premature baby in their NICU Institutions make the decision to discharge with the opinions of the doctor and nurse working in the unit With the FICare model it is thought that parents will be prepared for discharge bonding between parents and babies fulfilling their parental roles supporting babies breastfeeding reducing hospital stay enhancing parental-employee communication and increasing the quality of care services
Premature infants who were hospitalized for at least seven days between February 6 2020 and August 15 2021 in the NICU of a training and research hospital formed the population of the study In the study the total number of parents was determined as 68 when the margin of error was 5 the power level was 8117 and the effect size value was 070 At the end of the study a post hoc power analysis was conducted to determine the adequacy of the sample size As a result of the power analysis for the details of the difference between the groups in terms of the scale score of fathers with premature babies in the neonatal intensive care unit type 1 error 005 n 68 people effect size 1990 and the power level according to the structure was determined as 1000 To determine the difference in terms of the scale score of mothers with premature babies in the neonatal intensive care unit type 1 error 005 n 68 people effect size 2586 and power level according to temperature was determined as 1000 These values show that the sample size is sufficient
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