Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05525624 |
| Other study ID # |
0732 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2021 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Suleyman Demirel University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 infants.H1: 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
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-up/Interview: 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 baby's 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 baby's 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.
