Clinical trial NCT04705675: The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices
Official title: The Impact of Breastfeeding Education on Breastfeeding Behavior and the Use of Traditional Practices (An Example From Turkey): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breasfeeding Traditional Practices
Post Procedural Discharge
Keywords: Breastfeeding
Education
Behavior
Traditional practices
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed to be parallel group, randomized controlled study (1:1). Power was calculated using the GPower 3.1 program. In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.A total of 304 mothers were evenly and homogeneously assigned to both groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: H1a: The breastfeeding education has an effect the behaviors of mothers toward breastfeeding.

H1b: The breastfeeding education has an effect on the use of traditional breastfeeding practices.

H0a: The breastfeeding education has not an effect the behaviors of mothers toward breastfeeding.

H0b: The breastfeeding education has not an effect on the use of traditional breastfeeding practices.

Detailed description: The study was designed to be parallel group, randomized controlled study (1:1). The study universe consisted of all of the mothers presenting at the family health centers (FHC's) of a province in Turkey over the period February 1, 2018-October 31, 2018.

The study samples were included 152 study and 152 control group which individuals selected by simple random sampling.In the power analysis performed at a confidence interval of 95% and a margin of error of plus/minus 5%, sample size was calculated as a total of 304 mothers with 152 in the study group and 152 in the control group.

The researchers collected the data for the study. They administered the pretest and filled out the personal information form prior to the planned individual education. The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training. The researchers educated the mothers on breastfeeding techniques in an effort to encourage them to develop the skill of correctly using the positions taught and then the mothers were asked to practice what they had learned. The researcher took care to be positive and support whenever the mother attempted the right move in breastfeeding while also providing encouraging feedback when something went wrong. Included in the content of the education were the topics of the formation of breast milk and its benefits, the duration of breastfeeding, the sufficiency of breast milk, factors that reduced and increased it, things to look out for before breastfeeding, taking the right position for breastfeeding and positioning the baby on the breast, the steps in breastfeeding, burping the baby afterwards, milking and storing the mother's milk, and other issues that could pose problems during breastfeeding (Turkish Ministry of Health Basic Health Services General Directorate 2008). To test the retention of what was learned in the training, a posttest was administered to the groups one month following the education.

The Personal Information Form and the Breastfeeding Behaviors and Traditional Practices Assessment Form were used as data collection tools.

Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (means, standard deviation, frequencies and percentages) were used in the analysis of the findings. Normality tests (Kolmogorov-Smirnov Test) were performed on all continuous variables.

Eligibility criteria: Inclusion Criteria:

* To receive breasfeeding education
* To have singleton birth or one infant
* Not have complications postpartum period
* Not have chronic diseases or mental disorders
* Older than 18 years
* To voluntary to participate
* To know how to read, write and speak in Turkish
* To stay within this study until the end
* To have a newborn with no complications
* To have a 0-6 months healthy infants

Exclusion Criteria:

* Not receive breasfeeding education
* Having multiple birth or more than a baby
* Having complications postpartum period
* Having chronic diseases or mental disorders
* Younger than 18 years
* To refuse to participate
* Not knowing how to read, write and speak Turkish
* To leave early this study
* Having a newborn with complications
* Having a baby in need of medical care
* To have a older than 0-6 months infants

Primary outcomes:
measure: Pre-Education Mothers' traditional breastfeeding practices
timeFrame: 20 minute after the admittance to the family health centers
measure: Pre-Education Breastfeeding behavior
timeFrame: 20 minute after the admittance to the family health centers
Secondary outcomes:
measure: Post-Education
timeFrame: 1 month following the breastfeeding education.
measure: Post-Education
timeFrame: 1 month following the breasfeeding education.
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
References:
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citation: Del Ciampo LA, Del Ciampo IRL. Breastfeeding and the Benefits of Lactation for Women's Health. Rev Bras Ginecol Obstet. 2018 Jun;40(6):354-359. doi: 10.1055/s-0038-1657766. Epub 2018 Jul 6.