Breastfeeding Self-efficacyNCT06209658
Breastfeeding Education Given to Primiparous Mothers With the Teach-Back Method
A study testing breastfeeding education of Teach Back and breastfeeding education simple explanation in people with Breastfeeding Self-efficacy, run by Igdir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Self-efficacy
- What is being tested?
- breastfeeding education of Teach Back and breastfeeding education simple explanation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2023to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding Education Given to Primiparous Mothers With the Teach Back Method on Breastfeeding Self-Efficacy Perception and Anxiety Level
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.
Read the 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;
- Personal Information Collection Form
- Breastfeeding Self-Efficacy Scale
- 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.
- Conditions
- Breastfeeding Self-efficacy
- Being tested
- breastfeeding education of Teach Back, breastfeeding education simple explanation
- Keywords
- teach back method, breastfeeding self-efficacy perception, anxiety level, primiparous mother, breastfeeding education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding education of Teach BackDiagnostic test
breastfeeding education simple explanation is given and the woman is asked to explain and practice.
breastfeeding education simple explanationOther
breastfeeding education simple explanation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | breastfeeding education with Teach Back Receives: Diagnostic Test: breastfeeding education of Teach Back |
| Control Group | Other | breastfeeding education simple explanation Receives: Other: breastfeeding education simple explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of post-training data
Mothers will be given breastfeeding training 3 times using the Teach Back method. First breastfeeding training with teach-back method in the 2nd-5th week after birth. The second breastfeeding training takes place between days 13-17 after birth. Between days 30-42 after birth, the third breastfeeding training takes place. will be given between days. The Breastfeeding Self-Efficacy Scale will be administered after each breastfeeding training.
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.
Measured: two months
Collection of post-training data
The Beck Anxiety Scale will be administered after each breastfeeding education given with the Teach-Back method.
The scale, consisting of 21 questions, is a 4-point Likert type. Each item in the scale is scored between 0 (not at all) and 3 (serious). 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.
Measured: two months
Secondary outcomes (2)
Collection of post-training data
Mothers will be given breastfeeding training 3 times with a simple explanation method. The first simple explanation is breastfeeding education in the 2nd-5th postpartum period. Between days, second simple explanation breastfeeding education postpartum13th-17th. Between days, the third simple explanation breastfeeding education is between 30th and 42nd postpartum. will be given between days. The Breastfeeding Self-Efficacy Scale will be administered after each breastfeeding training.
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.
Measured: two month
Collection of post-training data
Beck Anxiety Scale will be applied after each breastfeeding education given with a simple explanation method.
The scale, consisting of 21 questions, is a 4-point Likert type. Each item in the scale is scored between 0 (not at all) and 3 (serious). 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.
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start18 Oct 2023
- Primary completion20 Mar 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Self-efficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 70 people, 35 in the experimental group and 35 in the control group, will be included in the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLHAN AKDEMİR, Igdir University
- Investigators
- gülhan akdemir, Study director, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209658
- Sponsor's protocol ID
- IgdirU
- Status last verified
- Sep 2024
- First submitted
- 10 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education Given to Primiparous Mothers With the Teach Back Method on Breastfeeding Self-Efficacy Perception and Anxiety Level
- ClinicalTrials.gov ID
- NCT06209658
- Acronym / sponsor ID
- IgdirU
- Conditions
- Breastfeeding Self-efficacy
- Keywords
- teach back method, breastfeeding self-efficacy perception, anxiety level, primiparous mother, breastfeeding education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Personal Information Collection Form
- Breastfeeding Self-Efficacy Scale
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 70 people, 35 in the experimental group and 35 in the control group, will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Diagnostic Test: breastfeeding education of Teach Backbreastfeeding education with Teach Back |
| Control Group | Other | Other: breastfeeding education simple explanationbreastfeeding education simple explanation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breastfeeding education of Teach Backbreastfeeding education simple explanation is given and the woman is asked to explain and practice. | Diagnostic test | experimental group |
| breastfeeding education simple explanationbreastfeeding education simple explanation | Other | Control Group |
Primary outcome
Collection of post-training data
Time frame: two months
Mothers will be given breastfeeding training 3 times using the Teach Back method. First breastfeeding training with teach-back method in the 2nd-5th week after birth. The second breastfeeding training takes place between days 13-17 after birth. Between days 30-42 after birth, the third breastfeeding training takes place. will be given between days. The Breastfeeding Self-Efficacy Scale will be administered after each breastfeeding training. 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.
Collection of post-training data
Time frame: two months
The Beck Anxiety Scale will be administered after each breastfeeding education given with the Teach-Back method. The scale, consisting of 21 questions, is a 4-point Likert type. Each item in the scale is scored between 0 (not at all) and 3 (serious). 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.
2 secondary outcomes
Collection of post-training data
Time frame: two month
Collection of post-training data
Time frame: two month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gülhan akdemir study director
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding education of Teach Back and breastfeeding education simple explanation in people with Breastfeeding Self-efficacy, run by Igdir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of post-training data (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.