Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05998681 |
| Other study ID # |
2022/3809 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: This study aims to investigate the effectiveness of education on breastfeeding and
basic maternal-neonatal care and mobile message support given to primiparous women in the
postpartum period on breastfeeding and motherhood experiences.
Methods: This prospective randomized controlled study was conducted in a hospital located in
a city in Turkiye, with 130 primiparous patients in the postpartum period (65 individuals in
the experimental group and 65 individuals in the control group). Participants in the
experimental group were provided with education on "Breastfeeding and Basic Maternal-Neonatal
Care" at the hospital and mobile messages were sent with the same content as education
program for 6 weeks after discharge.
Description:
Design This study was designed as a prospective randomized controlled study to determine the
effectiveness of education on breastfeeding and basic maternal-neonatal care applied to
primiparous women in the postpartum period and mobile messages on breastfeeding and
motherhood experience.
Sample Inclusion criteria for this study were: (1) Primiparous; (2) aged ≥18 years; (3)
having a healthy newborn; (4) participants who did not have an obstacle to postpartum
breastfeeding and agreed to participate in the study were included in the study by simple
random sampling method.
The study sample consisted of women hospitalized in the postpartum service of a hospital
located in a province in eastern Turkey. In the postpartum service of the hospital, women who
gave birth by vaginal or cesarean section are hospitalized. Early discharge procedures are
performed after 24 hours for women who have had a vaginal delivery, and 48 hours for women
who have had a cesarean delivery. Breastfeeding education is routinely provided in the
hospital's postpartum service; however, the continuity and effectiveness of breastfeeding are
not followed, and there is no information on neonatal care such as baby bathing, vaccination
time, and training on emergencies that require a doctor's consultation.
Power analysis was performed using a web-based software to calculate the sample size for the
research. The sample size was calculated as 65 for each group (65 participants in the
experimental group and 65 participants in the control group) with a 5% error level,
bidirectional significance level, 95% confidence interval, 80% ability to represent the
population (power), and assuming that the Breastfeeding Self-Efficacy score which is 48.2
(standard deviation 7.7) will increase by 4 points.
Measures A questionnaire was created to determine the introductory characteristics of women
and newborns and the breastfeeding process of women, and the Breastfeeding Self-Efficacy
Scale (BSES), IOWA-Infant Feeding Attitude Scale (IIFAS), and Being a Mother Scale (BaM-13)
were used to collect the data.
The BSES is a 33-item scale developed by Dennis and Faux in order to evaluate how competent
mothers feel about breastfeeding. Later, in 2003, a 14-item short form of the scale was
developed. The short form is easier to administer and accurately assesses breastfeeding
self-efficacy. The BSES is a 5-point Likert-type scale, with each item rated from 1 (never
sure) to 5 (always sure). The minimum score that can be obtained from the scale is 14, and
the maximum score is 70. High scores indicate high breastfeeding self-efficacy. The Turkish
adaptation of the scale was made by Tokat et al. and the Cronbach's alpha reliability
coefficient was found to be 0.86.
The IIFAS aims to determine mothers' attitudes toward breastfeeding and to estimate the
duration of breastfeeding. Cronbach's alpha reliability coefficient was determined as 0.71.
The scale is a five-point Likert type and the number of items is 17. The total attitude score
varies between 17 and 85, and a high score indicates a positive attitude toward
breastfeeding.
The BaM-13 was developed by Matthey in 2011, and its Turkish validity and reliability study
was conducted by Sevgi-Güler. The scale aims to determine mothers' experiences of motherhood.
The scale, which consists of a total of 13 items, is a 4-point Likert-type scale and each
item is scored between 0-3. The total score ranges from 0 to 39, and high scores on the scale
indicate less satisfaction with the "motherhood" experience. The Cronbach's alpha reliability
coefficient of the scale was determined as 0.76 .
Data Collection Data were collected between October 2022 and June 2023. The women assigned to
the experimental and control groups were first informed about the study. Introductory
characteristics such as age, educational level, employment, income level, whether the
pregnancy was planned and the gender of the baby, as well as the personal phone numbers of
the women, were recorded in the form created by the researchers. As pre-tests, the BSES,
IIFAS, and BaM-13 were applied. The pre-test data were collected by the researchers using
face-to-face interview method in the single rooms where the women stayed in the hospital.
The BSES, IIFAS, and BaM-13 were re-administered to all participants at postpartum 6 weeks as
post-tests. In addition, the method by which the participants continued to feed their babies,
their use of bottles or pacifiers, and their nipple problems were recorded in the form
created by the researchers. Post-test data were collected by the researchers by contacting
the participants by phone.
Intervention In the study, education on "Breastfeeding and Basic Maternal-Neonatal Care" was
given to the women in the experimental group within the first 24 hours after the birth, and
the training topics were sent as a mobile message for 6 weeks after the birth. Educational
content and messages created by the researchers in line with the guidelines of ACOG and WHO,
together with the literature review, were organized with the opinion of 5 experts who are
experts in their field. The content of education and mobile messages were as follows: the
importance of breastfeeding, breastfeeding techniques and things to be considered while
breastfeeding, milking and storage conditions, nipple problems, postpartum mother-neonatal
care, post-discharge emergencies.
Education on "Breastfeeding and Basic Maternal-Neonatal Care" was given to the participants
individually by B.E., one of the expert researchers. In addition, mobile messages were also
conveyed to the participants by B.E., one of the researchers. Education on "Breastfeeding and
Basic Maternal-Neonatal Care" was given in 2 postpartum sessions. In the first session,
breastfeeding education was given to women in practice, together with the first postpartum
breastfeeding. At the beginning of the second session, breastfeeding training was repeated
and then Basic Maternal-Neonatal Care training was given. The first session was given at the
first breastfeeding time, and the second session was given between 20-24 hours after birth.
Each session lasted approximately 20-25 minutes. In order to solve the problems of the
mothers, questions, and answers were made before discharge, and breastfeeding of the mothers
was observed. The trainings were given by the method of direct expression through brochures.
Information messages were sent by the researcher via mobile message between 08:00 and 10:00
every day for 6 weeks following the 1st day after discharge. No intervention was applied to
the women in the control group by the researcher. Breastfeeding training, which is included
in the standard care of the hospital, was given to these women by the healthcare
professionals in the clinic.
