Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05221463 |
Other study ID # |
360 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2021 |
Est. completion date |
December 25, 2021 |
Study information
Verified date |
February 2022 |
Source |
Ondokuz Mayis University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Breastfeeding rates of infants in intensive care units in the world and in Turkey are
undesirably low due to the conditions of infants, mothers and healthcare workers, which
threatens the health of newborns in many aspects in the early and future periods. It is
thought that the visual materials and tools used in breastfeeding education can be effective
both in the permanence of the acquired knowledge and in the transformation of the knowledge
into behavior. This study was conducted to determine the effect of video-assisted
breastfeeding and breastfeeding education given to mothers of hospitalized newborns on
breastfeeding self-efficacy and breastfeeding success.
Hypotheses Hypothesis 01: Video-assisted breastfeeding and breastfeeding education given to
mothers of hospitalized newborns does not affect breastfeeding self-efficacy of mothers.
Hypothesis 1: Video-assisted breastfeeding and breastfeeding education given to mothers of
hospitalized newborns increases mothers' breastfeeding self-efficacy.
Hypothesis 02: Video-assisted breast milk and breastfeeding education given to mothers of
hospitalized newborns does not affect mothers' breastfeeding success.
Hypothesis 2: Video-assisted breastfeeding and breastfeeding education given to mothers of
hospitalized newborns increases the breastfeeding success of mothers.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest
design. The research was carried out in the neonatal intensive care level 2 unit of a
university hospital located in the north of Turkey. In the study, mothers who met the
inclusion criteria were assigned to the education group (EG) (n=44) and the control group
(CG) (n=44), some mothers did not continue the education program and left the study. In this
case, the study was completed with 41 mothers in EG and 43 mothers in CG. Video assisted
breastfeeding training was given to the intervention group. Only the hospital's routine
general breastfeeding training was given to the control group, and no other intervention was
made.Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short
Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement
Tool were evaluated at the beginning of the study (pretest) and after three days of
breastfeeding training (posttest).
Description:
Breastfeeding rates of infants in intensive care units in the world and in Turkey are
undesirably low due to the conditions of infants, mothers and healthcare workers, which
threatens the health of newborns in many aspects in the early and future periods. The
education given to the mother by health care professionals; It has a great effect on the
initiation and maintenance of breastfeeding, prevention of breast complications and
successful breastfeeding. It is thought that the visual materials and tools used in
breastfeeding education can be effective both in the permanence of the acquired knowledge and
in the transformation of the knowledge into behavior. This study was conducted to determine
the effect of video-assisted breastfeeding and breastfeeding education given to mothers of
hospitalized newborns on breastfeeding self-efficacy and breastfeeding success.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest
design. The research was carried out in the neonatal intensive care level 2 unit of a
university hospital located in the north of Turkey.
The universe of the study consisted of mothers who were hospitalized in the neonatal
intensive care unit of the hospital where the study was conducted between 01.06.2021 and
25.12.2021 and came to breastfeed. Power analysis was performed using the G*Power (v3.1.7)
program to determine the number of samples.In the calculation made by assuming that the
evaluations to be made between two independent groups will have a large effect (d=0.80) on
the Breastfeeding Self-Efficacy Scale-Short Shape scale scores (Tokat et al. 2010), in order
to obtain 80% power (1-β) at the α=0.05 level. It was determined that there should be at
least 36 people in each group. Considering that there may be losses during the research
process, it was planned to recruit 44 people to each group. Three of the mothers (n=44) who
met the inclusion criteria and were included in the training group (EG), and one of the
mothers (n=44) who were included in the control group (KG) dropped out of the study by not
continuing the training program. In this case, the study was completed with 41 mothers in EG
and 43 mothers in CG.
The suitability of the mothers who came to the neonatal intensive care unit to breastfeed
their babies was evaluated by the researcher. The mothers who were willing and able to
participate in the study were given the necessary information about the study and their
written consent was obtained. The study had an intervention and a control group. The
researcher first gave video-assisted breastfeeding training to the intervention group for 3
days. On the third day after the training, feedback was received from the applications in the
video regarding the knowledge and skills of the mother, and the mother's questions were
answered. When these trainings were completed, other eligible mothers were included in the
control group. The control group was given only the hospital's routine general breastfeeding
training for 3 days and the questions of the mother were answered. The mothers in this group
performed the routine breastfeeding process and no other interventions were made.
First of all, sociodemographic and obstetric data of the mothers were collected by using the
introductory information form, and information about the infants was obtained by the
researcher from the infants' files. Breastfeeding self-efficacy with the Postpartum
Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH
Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study
(pretest) and after three days of breastfeeding training (posttest) before the training was
given.
Before starting this study, ethics committee approval was obtained from the Clinical Research
Ethics Committee of a University in northern Turkey (decision dated 28/05/2021, numbered
2021/239) and written permission from the relevant institution where the study was conducted.
In addition, the purpose of the study was explained to all participants before the data
collection form was applied, and written informed consent was obtained from those who
volunteered to participate in the study.