Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05525624
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-02-27
Brief Title:
Transition Model-Based Discharge Training in Parents of Preterm Infants
Sponsor:
Suleyman Demirel University
Organization:
Suleyman Demirel University
Study Overview
Official Title:
Evaluation of the Effectiveness of Transition Model-Based Discharge Training in Parents of Preterm InfantsDouble Blinded A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-04
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:
TRAMPRE
Brief Summary:
Infant and Child Monitoring Protocol prepared by the General Directorate of Mother and Child Health and Family Planning of the Ministry of Health regarding the monitoring of postpartum processes in our country However there is no separate recommendation for home follow-up and care of mothers and babies who gave birth preterm In addition there are deficiencies in the effective conduct of home visits specified in these guides In addition to the parents lack of knowledge about the long-term follow-up and care of these babies the coordination between primary and secondary health care providers and senior health care providers is not at the desired level In addition to all these services such as training and consultancy cannot be carried out due to disruptions in many polyclinic services due to the COVID-19 pandemic worldwide For this reason there is a need to develop programs for home care and follow-up of preterm infants who are a sensitive population in terms of both reducing the patient density in hospitals and reducing the hospital return rates of preterm infants In this context the aim of our research is The aim of this study is to evaluate the effectiveness of discharge training based on the Transition Model in parents with preterm infantsH1 In the group in which the interventions based on the Transition Model are applied the information needs of the parents will be met more compared to the control group H1 Parent-infant role development will be higher in the group in which interventions based on the Transition Model are applied H1 The level of coping with stress will be better in the group in which interventions based on the Transition Model are applied H1 The level of grief will be lower in the group in which interventions based on the Transition Model are applied H1 The level of postpartum depression will be lower in the group in which interventions based on the Transition Model are applied H1 Babies in the group in which interventions based on the Transition Model are applied will have fewer hospital admissions except for the planned outpatient visit
Detailed Description:
Intervention Group The intervention protocol of the research will be based on the Transition Model Discharge training will be applied to the participants in line with the Preterm Baby Care Guide at the discharge stage Weekly telephone follow-up will be carried out for 12 weeks after discharge Applications to be made to the initiative group are given below Phone Follow-upInterview During the first 12 weeks following the discharge of the preterm baby parents will be interviewed by phone at least once a week During the interview issues concerning the babys health status baby bed physical conditions of the house newborn jaundice nutrition etc will be included in the scope of the interview and suggestions will be made for the babys growth and development in healthy conditions safe sleep clothing selection etc Interviews will be held in line with the Baby Care Skill Form and each interview will be recorded in the form The duration and number of interviews will be determined according to the needs of the parent In addition in this process information such as which health institution application has been made the degree of the institution applied primary secondary tertiary health institution will be recorded Control Group Participants in this group will be included in the routine neonatal clinic discharge training of the hospital where the research was conducted and no intervention will be applied The Parents and Preterm Baby General Information Form will be applied to the parents who agreed to participate in the study at the first interview and when the data collection process of the research is completed these parents will be contacted by phone and the Transition Scale and Edinburgh Postnatal Depression Scale will be applied As in the intervention group information such as the status of application to the health institution the reason for the application and the degree of the institution applied to primary secondary tertiary health institution will be recorded in this group Statistical Package of Social Science SPSS 23 package program will be used in the evaluation of the data obtained from the research For the intervention and control groups the Cronbach Alpha coefficient scale score average and minimum-maximum values will be calculated for the pre-test and post-test In order to compare the pre-test and post-test data of the intervention and control groups the t-test for the difference of the mean of the two peer groups t-test of two paired groups the Wilcoxon Signed Ranks Test and the Wilcoxon Signed Ranks Test and the Mann Whitney-U Test for the data without normal distribution will be performed
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