Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06035419 |
Other study ID # |
PAU SBF |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2, 2019 |
Est. completion date |
February 15, 2020 |
Study information
Verified date |
September 2023 |
Source |
Pamukkale University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Feeding the infant with breast milk in neonatal intensive care units is essential. However,
breastfeeding can be adversely affected in this complex environment, especially for immigrant
mothers. In order to ensure the success of breastfeeding in the neonatal intensive care unit,
education and support of the mother are required. While doing this, structured and planned
education programs should be implemented taking into account the individual characteristics
of the mother (culture, age, etc.).This study aimed to evaluate the effect of education given
to immigrant mothers on breastfeeding success of mothers. The study was a randomized
controlled, single-blind clinical trial.
Description:
This study aimed to evaluate the effect of education given to immigrant mothers on
breastfeeding success of mothers.
Method: In this randomized-controlled, single-blind study, 80 immigrant mothers (40
intervention groups, 40 control groups) were recruited.
The study included primiparous immigrant mothers whose mother tongue was not Turkish, whose
baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of
gestation, whose baby was fed orally, and whose suckling was not impaired.
In the study, 40 participants were included in the experimental group and 40 participants in
the control group. At the end of the study, Cohen's d was calculated to determine the effect
size and was found to be 1.80.
A simple randomization method was used to randomly assign the mothers included in the study
to the experimental and control groups. To avoid bias in the study, a nurse who was not
involved in the study made the LATCH scoring and evaluation of the suckling time and feeding
style of the infants, without knowing which group the mothers were in. In addition, mothers
to be included in the experimental and control groups were determined by a simple
randomization method to prevent selection bias in the study.
Mother-baby information form, Nutrition follow-up form, and LATCH were used to collect the
study data.
The mothers to be included in the study were informed by an interpreter before the study and
their consent was obtained. It was ensured that the mothers in both groups answered the
questions in the data collection forms through a translator. Information about the baby was
taken from the patient's file.
A specially prepared training program for immigrant mothers was applied to the mothers in the
experimental group. In the control group, no interventions were made except for the routine
interventions of the clinic (unstructured training practices given by the individual effort
of the nurse).
The first of the parameters used to evaluate breastfeeding success is the mothers' LATCH
score averages. LATCH scores of mothers were evaluated by observation. LATCH evaluations of
the mothers in the experimental group were made at the first breastfeeding before the
training and on the 1st, 2nd, and 3rd days after the training. The LATCH evaluations of the
control group were made at the first breastfeeding and on the 1st, 2nd, and 3rd days.
Another parameter examined to evaluate breastfeeding success is the suckling time of babies
at each breastfeeding. The suckling time of the babies was measured with a stopwatch at each
feeding.
The last of the parameters to evaluate breastfeeding success is the feeding style of infants.
Information about the feeding style of infants was obtained from the nurse observation form.