Clinical trial NCT06209658: Breastfeeding Education Given to Primiparous Mothers With the Teach-Back Method
Official title: The Effect of Breastfeeding Education Given to Primiparous Mothers With the Teach Back Method on Breastfeeding Self-Efficacy Perception and Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Self-efficacy
Keywords: teach back method
breastfeeding self-efficacy perception
anxiety level
primiparous mother
breastfeeding education
Lead sponsor: Igdir University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 70 people, 35 in the experimental group and 35 in the control group, will be included in the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Teach-Back method was initially developed as a communication technique for patients to remember important information about their diagnosis, treatment or medication and to understand what to do. Method; It requires recalling and explaining any information learned during the interaction between the healthcare team and clients. It has been seen that the use of the tell-what-you-learned method can be used effectively in increasing the learning and comprehension level of individuals who lack health knowledge, contributing to positive health behaviors and reducing the return to health institutions, and it has begun to be used in different areas that require patient education. There are no examples of studies in which the tell-what-you-learned method, which has been brought to the agenda and implemented abroad in recent years, is used in our country.

The development of breastfeeding self-efficacy is a very challenging process. Postpartum anxiety occurs in women with low breastfeeding self-efficacy perception. Different training methods are used to initiate and maintain breastfeeding. However, there is no generally accepted method that can bridge the communication gap between patients and healthcare professionals and can be used in health education. It is important to use the tell-what-you-learned method, which is used in patient/client training and is expressed as a communication technique based on expressing what the caregivers have learned in their own words, as it is not enough for the individuals being cared for to say "I understand", in terms of increasing the success of breastfeeding and improving the health of the mother and baby.

Detailed description: The purpose of this study is to evaluate the effect of breastfeeding education given using the tell-what-you-learned method on breastfeeding self-efficacy perception and anxiety level.The population of the research consists of women who gave birth at Iğdır State Hospital in the last 6 months of 2022. According to the records of Iğdır Provincial Health Directorate Statistics Department, for 2022; A total of 1351 live births took place in Iğdır State Hospital in the relevant period, including 257 in July, 269 in August, 213 in September, 207 in October, 188 in November and 217 in December.

Power analysis was performed to determine the sample size. The power of the research is defined as the possibility of revealing the difference between two applications. The power of the study is expressed as 1 - ß probability of error, and in general, studies must have at least 80% power. The minimum number of individuals required to be included in the sample of the study was calculated using the G-power 3.1.9.7 program, based on the data of the study titled "The effect of antenatal education based on strengthening the perception of breastfeeding self-efficacy on the perception of breastfeeding self-efficacy and breastfeeding success". Alpha margin of error was determined as 5%, the power of the study was determined as 80% (Effect Size: 0.70), and it was observed that there should be at least 34 people in each group. A total of 68 women will be included in the sample, including 34 study and 34 control groups. Postpartum women who meet the inclusion criteria for the study will be selected to the intervention and control groups by simple randomization.Taking into account the inclusion and exclusion criteria, women will be divided into intervention and control groups by simple randomization method. A random number generation program (Research Randomizer) will be used in the randomization of the sample. The randomization process will be created by an impartial researcher who is not involved in the research. Women will not be informed about the groups they are in, only the researcher will know which group they will be in, and single blindness will be ensured in the study.Intervention and control group data in the study;

1. Personal Information Collection Form
2. Breastfeeding Self-Efficacy Scale
3. It will be collected using the Beck Anxiety Scale (BAI). The Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert-type scale consisting of 14 items (1: not at all confident and 5: always confident). The lowest score that can be obtained from the scale is 14 and the highest score is 70. A high score indicates high breastfeeding self-efficacy.Beck Anxiety Scale Beck Anxiety Scale: The lowest score that can be obtained from the scale is 0 and the highest score is 63. An increase in the score obtained from the scale indicates that the individual's anxiety increases. A total score from the scale between 8 and 15 indicates mild anxiety, between 16 and 25 indicates moderate anxiety, and between 26 and 63 indicates severe anxiety.

Research data will be evaluated using SPSS 21.0 program. Homogeneity of the groups will be evaluated by Chi Square test for categorical variables, Mann Whitney U or t test for independent groups, depending on the data for numerical variables. Multiway Analysis of Variance in Repeated Measurements will be used to compare Breastfeeding Self-Efficacy Scale mean scores in the intervention and control groups according to group, time and group-time interaction. In further analysis of the difference between the breastfeeding self-efficacy scale mean scores in the intervention and control groups, One-Way Analysis of Variance in Repeated Measurements will be used to compare the mean scores of the groups among themselves, and the T-Test in Dependent Groups with Bonferroni Correction will be used to compare the measurements with each other.

Eligibility criteria: Inclusion Criteria:

* Living in Iğdır city center
* Ability to read and write
* Don't be primiparous
* Giving birth at term and in a healthy manner
* Having a healthy newborn
* Having had a vaginal or cesarean birth

Exclusion Criteria:

* Living in Iğdır city center
* Ability to read and write
* Don't be primiparous
* Giving birth at term and in a healthy manner
* Having a healthy newborn
* Having had a vaginal or cesarean birth

Primary outcomes:
measure: Collection of post-training data
timeFrame: two months
measure: Collection of post-training data
timeFrame: two months
Secondary outcomes:
measure: Collection of post-training data
timeFrame: two month
measure: Collection of post-training data
timeFrame: two month
Other outcomes:
Locations:
city: Iğdır
country: Turkey
facility: Dr. Nevruz Erez State Hospital
Study officials:
affiliation: Igdir University
name: gülhan akdemir
role: STUDY_DIRECTOR
References: