BreastfeedingNCT05902481
The Effect of Mixed Reality Technology-Based Breastfeeding Counseling on Breastfeeding Success and Self-Efficacy of Women
A study testing Education in people with Breastfeeding and Breast Milk Expression, run by Tarsus University.
Trial summary
Breast-feeding; It is the basic step of newborn, maternal and community health. Breastfeeding counseling, which is planned to encourage, initiate and continue breastfeeding in line with the recommendations of the World Health Organization, is extremely important in order to achieve the Sustainable Development Goals. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breast Milk Expression, Pregnancy Related
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Jan 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 38-40. Continuing pregnancy between gestational weeks,
- Primigravida,
- Those who have not received a planned breastfeeding training before,
- Pregnant women who agree to participate in the study will be included.
Who cannot join
- Having a risky pregnancy,
- Postpartum mother and/or baby have a health condition that prevents breastfeeding,
- Having multiple pregnancy,
- The mother and/or baby hospitalized for the first 7 days,
- Can't speak or understand Turkish,
- Women with intellectual disability and serious mental disorders will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Breast-feeding; It is the basic step of newborn, maternal and community health. Breastfeeding counseling, which is planned to encourage, initiate and continue breastfeeding in line with the recommendations of the World Health Organization, is extremely important in order to achieve the Sustainable Development Goals. Breastfeeding counseling with mixed reality technology will contribute to the literature.
The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room. The universe will consist of all pregnant women who come to the obstetrics clinics of the specified hospitals for follow-up purposes. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as 102 people, with at least 51 people in the intervention group and at least 51 people in the control group. The sample number was determined as 112 pregnant women to receive 10% (5 each) for the intervention and control groups in case the participants dropped out of the study. In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias.
Read more
In the intervention group; Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test to pregnant women in their 3rd trimester and breastfeeding counseling based on mixed reality technology will be given. The LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale will be filled in within 24 hours and on the 7th day after giving birth. The same steps will be performed for the pregnant women in the control group, and unlike the intervention group, counseling will be applied with Power Point technique instead of mixed reality technology. Statistical analyzes will be made using a package program called SPSS (IBM SPSS Statistics 24). In descriptive statistical analysis, mean, standard deviation, median, frequency, percentile, minimum and maximum values will be calculated. Descriptive, parametric and nonparametric statistical analysis methods will be used in the analysis of the data.
Various studies have been conducted in Turkey using different methods on breastfeeding counseling, but no study has been found in which breastfeeding counseling was provided with mixed reality technology. Therefore, a randomized controlled experimental type study will be conducted to evaluate the effect of mixed reality technology-based breastfeeding counseling on breastfeeding success and self-efficacy of women.
Read the detailed description
No study has been found in Turkey that provides breastfeeding counseling with mixed reality technology. It is predicted that counseling provided with the use of mixed reality technology will increase breastfeeding self-efficacy and success. It is envisaged that the results obtained will be presented in scientific environments and used as an evidence-based practice in increasing both the rate and success of breastfeeding after being published as an article. The results of a randomized controlled trial with high evidential value are expected to be available for use by both healthcare professionals and mothers. By helping the results of the study to realize the recommendations of the World Health Organization regarding breastfeeding; It is thought that it will benefit newborn, maternal and community health, thus making a significant contribution to the promotion, initiation and maintenance of breastfeeding, which is the first step towards achieving the Sustainable Development Goals.In order to evaluate the effect of breastfeeding counseling based on mixed reality technology on breastfeeding success and self-efficacy of women, it will be conducted in a randomized controlled experimental type.
Methods The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room.
The population of the study will be composed of pregnant women who applied to the obstetrics and gynecology outpatient clinics of hospitals with delivery rooms in Mersin between January 2023 and December 2024 for follow-up. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as a total of 102 people, with at least 51 for the intervention group (the group given breastfeeding counseling based on mixed reality technology) and at least 51 for the control group (the group where breastfeeding counseling was given with the standard education method). The sample number of the study group was determined as 112 pregnant women, 10% for the intervention group and 10% (5 people) for the control group, against the possibility of the participants dropping out of the study.
Data Collection Intervention Group Data Collection in the Prenatal Period 38-40 students who agreed to participate in our study and met the inclusion criteria. Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age. The data will be collected by face-to-face interview technique and is expected to take about 15 minutes.
After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology. Breastfeeding counseling; It is an educational program that includes breast milk and its properties, benefits of breast milk for mother and baby, breast anatomy, breastfeeding positions, expressing and storing breast milk. This counseling will be applied to pregnant women with mixed reality technology and will take approximately 20 minutes.
Data Collection in the Postpartum Period The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher by observation within the first 24 hours after the pregnant women in the intervention group participating in our study give birth. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a post-test. Data collection will take approximately 15 minutes.
The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation on the 7th day after giving birth to the pregnant women in the intervention group participating in our study. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a posttest repetition. The interview will be concluded by completing the Postpartum Period Status and Satisfaction Evaluation Form. Data collection will take approximately 15 minutes.
Control Group Data Collection in the Prenatal Period Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women in the third trimester who agreed to participate in our study and met the inclusion criteria. The data will be collected by face-to-face interview technique and is expected to take about 15 minutes.
After the pre-test is applied, standard breastfeeding counseling will be given to pregnant women with Power Point technique. It is an educational program that includes breastfeeding counseling, breast milk and its properties, the benefits of breast milk for mother and baby, breast anatomy, breastfeeding positions, expressing and storing breast milk. This counseling will be applied to pregnant women with Power Point technique and it will take about 20 minutes.
Data Collection in the Postpartum Period The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation within the first 24 hours after the pregnant women in the control group participating in our study give birth. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a post-test. Data collection will take approximately 15 minutes.
The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation on the 7th day after giving birth to the pregnant women in the intervention group participating in our study. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a posttest repetition. The interview will be concluded by completing the Postpartum Period Status and Satisfaction Evaluation Form. Data collection will take approximately 15 minutes.
- Conditions
- Breastfeeding, Breast Milk Expression, Pregnancy Related
- Being tested
- Education
- Keywords
- Breast milk, Breastfeeding, Breastfeeding counseling, Antenatal period, Mixed reality technology
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
education about breastfeeding with mixed reality technology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age.
After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology. Receives: Other: Education |
| Control Group | No intervention | Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women in the third trimester who agreed to participate in our study and met the inclusion criteria. After the pre-test is applied, standard breastfeeding counseling will be given to pregnant women with Power Point technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal Breastfeeding Self-Efficacy Scale
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.
Measured: 1 day
Postpartum Breastfeeding Self-Efficacy Scale
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.The difference of the antenatal form of the scale from the postnatal form is the use of the phrase "future tense" in the scale items.
Measured: 1 day
LATCH Breastfeeding Diagnosis and Evaluation Scale
The LATCH Breastfeeding Diagnostic and Evaluation Scale was developed by Jensen et al. in 1994 (36). The Turkish validity and reliability of the scale were performed by Demirhan and Pek in 1997, Koyun in 2001, and Yenal and Okumuş in 2003 (37,38). The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.
Measured: 1 day
Postpartum Breastfeeding Self-Efficacy Scale
It was developed by the researcher in line with the literature in order to determine the characteristics of infants and breastfeeding in the postnatal period. In the form, data related to the birth process such as the week of gestation, the mode of delivery and the situation of experiencing problems during delivery; There are 11 questions questioning the breastfeeding experience, such as the baby's gender, height and weight, the time of first breastfeeding, problems during breastfeeding, and the first food given to the baby.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias. Pregnant women who meet the criteria for inclusion in the study according to block randomization will be homogeneously distributed to each training group according to their gestational week.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Guray, Tarsus University
- Investigators
- Meltem Akbaş, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902481
- Sponsor's protocol ID
- 127
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Alliance for Breastfeeding Action (WABA). Messages for World Health Day 2022 - Breastfeeding Is A Climate-smart Decision. https://waba.org.my/ . Erişim Tarihi: 12.10.2022
Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.
PubMed 26172878Krol KM, Grossmann T. Psychological effects of breastfeeding on children and mothers. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Aug;61(8):977-985. doi: 10.1007/s00103-018-2769-0.
PubMed 29934681Tewabe T. Prelacteal Feeding Practices among Mothers in Motta Town, Northwest Ethiopia: A Cross-sectional Study. Ethiop J Health Sci. 2018 Jul;28(4):393-402. doi: 10.4314/ejhs.v28i4.5.
PubMed 30607052Rozga MR, Kerver JM, Olson BH. Self-reported reasons for breastfeeding cessation among low-income women enrolled in a peer counseling breastfeeding support program. J Hum Lact. 2015 Feb;31(1):129-37; quiz 189-90. doi: 10.1177/0890334414548070. Epub 2014 Aug 26.
PubMed 25158829Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
PubMed 29482516Alakaam A. Demand for Lactation Leads to Flowing Supply of Success: Support Requested from States to Improve Breastfeeding Practices. J Midwifery Womens Health. 2019 Nov;64(6):699-702. doi: 10.1111/jmwh.12977. Epub 2019 Jul 9. No abstract available.
PubMed 31287205Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
PubMed 27654119Khorshidifard M, Amini M, Dehghani Mr, Zaree N, Pishva N & Zarifsanaiey N. Assessment of breastfeeding education by face to face and small-group education methods in mothers' self-efficacy in Kazeroun Health Centers in 2015. Women's Health Bulletin, 2017, 4(3):2-6.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mixed Reality Technology-Based Breastfeeding Counseling on Breastfeeding Success and Self-Efficacy of Women
- ClinicalTrials.gov ID
- NCT05902481
- Acronym / sponsor ID
- 127
- Conditions
- Breastfeeding, Breast Milk Expression, Pregnancy Related
- Keywords
- Breast milk, Breastfeeding, Breastfeeding counseling, Antenatal period, Mixed reality technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 15 Jun 2023 (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.
Breast-feeding; It is the basic step of newborn, maternal and community health. Breastfeeding counseling, which is planned to encourage, initiate and continue breastfeeding in line with the recommendations of the World Health Organization, is extremely important in order to achieve the Sustainable Development Goals. Breastfeeding counseling with mixed reality technology will contribute to the literature.
The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room. The universe will consist of all pregnant women who come to the obstetrics clinics of the specified hospitals for follow-up purposes. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as 102 people, with at least 51 people in the intervention group and at least 51 people in the control group. The sample number was determined as 112 pregnant women to receive 10% (5 each) for the intervention and control groups in case the participants dropped out of the study. In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias.
In the intervention group; Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test to pregnant women in their 3rd trimester and breastfeeding counseling based on mixed reality technology will be given. The LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale will be filled in within 24 hours and on the 7th day after giving birth. The same steps will be performed for the pregnant women in the control group, and unlike the intervention group, counseling will be applied with Power Point technique instead of mixed reality technology. Statistical analyzes will be made using a package program called SPSS (IBM SPSS Statistics 24). In descriptive statistical analysis, mean, standard deviation, median, frequency, percentile, minimum and maximum values will be calculated. Descriptive, parametric and nonparametric statistical analysis methods will be used in the analysis of the data.
Various studies have been conducted in Turkey using different methods on breastfeeding counseling, but no study has been found in which breastfeeding counseling was provided with mixed reality technology. Therefore, a randomized controlled experimental type study will be conducted to evaluate the effect of mixed reality technology-based breastfeeding counseling on breastfeeding success and self-efficacy of women.
Detailed description
No study has been found in Turkey that provides breastfeeding counseling with mixed reality technology. It is predicted that counseling provided with the use of mixed reality technology will increase breastfeeding self-efficacy and success. It is envisaged that the results obtained will be presented in scientific environments and used as an evidence-based practice in increasing both the rate and success of breastfeeding after being published as an article. The results of a randomized controlled trial with high evidential value are expected to be available for use by both healthcare professionals and mothers. By helping the results of the study to realize the recommendations of the World Health Organization regarding breastfeeding; It is thought that it will benefit newborn, maternal and community health, thus making a significant contribution to the promotion, initiation and maintenance of breastfeeding, which is the first step towards achieving the Sustainable Development Goals.In order to evaluate the effect of breastfeeding counseling based on mixed reality technology on breastfeeding success and self-efficacy of women, it will be conducted in a randomized controlled experimental type.
Methods The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room.
The population of the study will be composed of pregnant women who applied to the obstetrics and gynecology outpatient clinics of hospitals with delivery rooms in Mersin between January 2023 and December 2024 for follow-up. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as a total of 102 people, with at least 51 for the intervention group (the group given breastfeeding counseling based on mixed reality technology) and at least 51 for the control group (the group where breastfeeding counseling was given with the standard education method). The sample number of the study group was determined as 112 pregnant women, 10% for the intervention group and 10% (5 people) for the control group, against the possibility of the participants dropping out of the study.
Data Collection Intervention Group Data Collection in the Prenatal Period 38-40 students who agreed to participate in our study and met the inclusion criteria. Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age. The data will be collected by face-to-face interview technique and is expected to take about 15 minutes.
After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology. Breastfeeding counseling; It is an educational program that includes breast milk and its properties, benefits of breast milk for mother and baby, breast anatomy, breastfeeding positions, expressing and storing breast milk. This counseling will be applied to pregnant women with mixed reality technology and will take approximately 20 minutes.
Data Collection in the Postpartum Period The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher by observation within the first 24 hours after the pregnant women in the intervention group participating in our study give birth. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a post-test. Data collection will take approximately 15 minutes.
The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation on the 7th day after giving birth to the pregnant women in the intervention group participating in our study. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a posttest repetition. The interview will be concluded by completing the Postpartum Period Status and Satisfaction Evaluation Form. Data collection will take approximately 15 minutes.
Control Group Data Collection in the Prenatal Period Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women in the third trimester who agreed to participate in our study and met the inclusion criteria. The data will be collected by face-to-face interview technique and is expected to take about 15 minutes.
After the pre-test is applied, standard breastfeeding counseling will be given to pregnant women with Power Point technique. It is an educational program that includes breastfeeding counseling, breast milk and its properties, the benefits of breast milk for mother and baby, breast anatomy, breastfeeding positions, expressing and storing breast milk. This counseling will be applied to pregnant women with Power Point technique and it will take about 20 minutes.
Data Collection in the Postpartum Period The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation within the first 24 hours after the pregnant women in the control group participating in our study give birth. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a post-test. Data collection will take approximately 15 minutes.
The LATCH Breastfeeding Diagnosis and Evaluation Scale will be filled by the researcher through observation on the 7th day after giving birth to the pregnant women in the intervention group participating in our study. Postpartum Breastfeeding Self-Efficacy Scale will be applied as a posttest repetition. The interview will be concluded by completing the Postpartum Period Status and Satisfaction Evaluation Form. Data collection will take approximately 15 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias. Pregnant women who meet the criteria for inclusion in the study according to block randomization will be homogeneously distributed to each training group according to their gestational week.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: EducationIntroductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age. After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology. |
| Control Group | No intervention | –Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women in the third trimester who agreed to participate in our study and met the inclusion criteria. After the pre-test is applied, standard breastfeeding counseling will be given to pregnant women with Power Point technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 38-40. Continuing pregnancy between gestational weeks,
- Primigravida,
- Those who have not received a planned breastfeeding training before,
- Pregnant women who agree to participate in the study will be included.
Key exclusion criteria (6 listed)
- Having a risky pregnancy,
- Postpartum mother and/or baby have a health condition that prevents breastfeeding,
- Having multiple pregnancy,
- The mother and/or baby hospitalized for the first 7 days,
- Can't speak or understand Turkish,
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 |
|---|---|---|
| Educationeducation about breastfeeding with mixed reality technology. | Other | Intervention Group |
Primary outcome
Antenatal Breastfeeding Self-Efficacy Scale
Time frame: 1 day
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.
Postpartum Breastfeeding Self-Efficacy Scale
Time frame: 1 day
Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.The difference of the antenatal form of the scale from the postnatal form is the use of the phrase "future tense" in the scale items.
LATCH Breastfeeding Diagnosis and Evaluation Scale
Time frame: 1 day
The LATCH Breastfeeding Diagnostic and Evaluation Scale was developed by Jensen et al. in 1994 (36). The Turkish validity and reliability of the scale were performed by Demirhan and Pek in 1997, Koyun in 2001, and Yenal and Okumuş in 2003 (37,38). The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.
Postpartum Breastfeeding Self-Efficacy Scale
Time frame: 1 day
It was developed by the researcher in line with the literature in order to determine the characteristics of infants and breastfeeding in the postnatal period. In the form, data related to the birth process such as the week of gestation, the mode of delivery and the situation of experiencing problems during delivery; There are 11 questions questioning the breastfeeding experience, such as the baby's gender, height and weight, the time of first breastfeeding, problems during breastfeeding, and the first food given to the baby.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- BackgroundWorld Alliance for Breastfeeding Action (WABA). Messages for World Health Day 2022 - Breastfeeding Is A Climate-smart Decision. https://waba.org.my/ . Erişim Tarihi: 12.10.2022
- Background: PubMed 26172878Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.
- Background: PubMed 29934681Krol KM, Grossmann T. Psychological effects of breastfeeding on children and mothers. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Aug;61(8):977-985. doi: 10.1007/s00103-018-2769-0.
- Background: PubMed 30607052Tewabe T. Prelacteal Feeding Practices among Mothers in Motta Town, Northwest Ethiopia: A Cross-sectional Study. Ethiop J Health Sci. 2018 Jul;28(4):393-402. doi: 10.4314/ejhs.v28i4.5.
- Background: PubMed 25158829Rozga MR, Kerver JM, Olson BH. Self-reported reasons for breastfeeding cessation among low-income women enrolled in a peer counseling breastfeeding support program. J Hum Lact. 2015 Feb;31(1):129-37; quiz 189-90. doi: 10.1177/0890334414548070. Epub 2014 Aug 26.
- Background: PubMed 29482516Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.
- Background: PubMed 31287205Alakaam A. Demand for Lactation Leads to Flowing Supply of Success: Support Requested from States to Improve Breastfeeding Practices. J Midwifery Womens Health. 2019 Nov;64(6):699-702. doi: 10.1111/jmwh.12977. Epub 2019 Jul 9. No abstract available.
- Background: PubMed 27654119Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
- BackgroundKhorshidifard M, Amini M, Dehghani Mr, Zaree N, Pishva N & Zarifsanaiey N. Assessment of breastfeeding education by face to face and small-group education methods in mothers' self-efficacy in Kazeroun Health Centers in 2015. Women's Health Bulletin, 2017, 4(3):2-6.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Meltem Akbaş study director
Cukurova University
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Breastfeeding and Breast Milk Expression, run by Tarsus University.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda Güray (+903246000033, sedaguray@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal Breastfeeding Self-Efficacy Scale (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05902481, which also lists 9 linked publications.
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 15 Jun 2023.