Breastfeeding, ExclusiveNCT06266806
The Effect of Breastfeeding Counseling on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes
A study testing Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources in people with Breastfeeding, Exclusive and Nurse's Role, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Nurse's Role, Self Efficacy
- What is being tested?
- Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- 28-37. be between weeks,
- Being primiparous,
- Having a healthy singleton pregnancy,
- Being at least a primary school graduate,
- Living with his/her spouse,
- There is a relative who will support the mother, whom she defines as a relative (spouse, the woman's mother, or mother-in-law), and this person also agrees to participate in the study,
- There is no condition that prevents breastfeeding for the mother and the baby (medication use, history of any psychiatric or chronic disease, history of any disease in the baby such as cleft palate-lip, etc.),
Who cannot join
- Not filling out the forms in the study or filling them incompletely,
- The participant wishes to leave the research,
- The emergence of a condition that prevents breastfeeding in the mother and baby,
- Moving from the city where the work is done or moving out of the town,
- Family support is for less than 1 month,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kars Harakani State Hospital
Kars, Center, 36100
Kars Harakani State Hospital, +090 474 212 56 68, karsdhs3@saglik.gov.tr
Hümeyra TÜLEK DENİZ, Lecturer, MSc
About this study
Official title: The Effect of the Theory-Based Breastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes
The purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception, breastfeeding self-efficacy and outcomes. The study will involve pregnant women and close others assigned randomly to the intervention (n=50) or control (n=50) groups in a state hospital in Turkey. Individual counseling will be provided to the intervention group within the scope of the EMÖZGEDAP, based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). The Antenatal Breastfeeding Self-Efficacy Scale will be evaluated before the counseling program is given in the antepartum period. Breastfeeding and Nutrition Results, Postpartum Breastfeeding Self-Efficacy Scale, Breastfeeding Self-Efficacy Scale for Fathers, Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy and Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy will be evaluated at the 1st, 3rd, and 6th months postpartum.
Read the detailed description
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that babies start breastfeeding within the first hour after birth and be exclusively breastfed for the first six months. In this situation, the baby is not given any other food or liquid, including water, defined as "full breastfeeding." Breastfeeding schemes were developed by Labbok and Krosovec in 1990 to ensure consistency in research. According to this scheme, breastfeeding methods are divided into full, partial, and symbolic, according to the baby's nutritional characteristics. According to the Turkey Demographic and Health Survey (TNSA, 2018) data, 98% of children are breastfed at some point, and 42% receive food other than breast milk in the pre-lacteal (before breastfeeding) period. In Turkey, 71% of children under two are breastfed within the first hour after birth, and only 41% of babies under six months are exclusively breastfed.
Self-efficacy is an essential factor in breastfeeding at the desired level. Influenced by Bandura's definition of self-efficacy, Cindy-Lee Dennis developed the "Breastfeeding Self-Efficacy Theory" by identifying the sources and influencing factors of Breastfeeding Self-Efficacy Perception. According to Dennis and Faux, a mother's breastfeeding self-efficacy includes whether she breastfeeds her baby, how much time she spends caring for her baby, her thoughts about breastfeeding, and her ability to cope with emotional difficulties during breastfeeding. Mothers with high self-efficacy encourage themselves to face challenges and try to solve events by thinking positively. These mothers prefer breastfeeding more, are more courageous, and act ultimately when they experience difficulties. Mother's breastfeeding self-efficacy is affected by four primary sources of information: The mother's previous experiences regarding breastfeeding, the examples the mother sees from others regarding breastfeeding, the support of the environment regarding breastfeeding, and the mother's psychological state regarding breastfeeding. Healthcare personnel should influence these factors to improve self-efficacy. Maternal breastfeeding self-efficacy has been identified as an important modifiable factor for successful breastfeeding.
Various factors, such as breastfeeding self-efficacy and social support, affect the sustainability of breastfeeding. The studies stated that social and especially spousal support is adequate for successful breastfeeding and the mother's decision to breastfeed early at birth. According to some studies, those with more social support have higher breastfeeding self-efficacy rates. The studies emphasized that family support is an essential factor in encouraging breastfeeding. The failure of family members to provide adequate breastfeeding support and information to women resulted in the use of formula. It is stated that the older generation, especially the baby's grandmother or paternal grandmother, plays a central role in various aspects of pregnancy decision-making and child-rearing within the family structure. A study conducted among mothers-in-law in Nepal found that mothers-in-law "view themselves as key providers and decision makers of perinatal care practices." Therefore, the woman needs to receive support from her social circle through participation and encouragement during breastfeeding.
Hypnobreastfeeding is a relaxation technique that helps improve the breastfeeding process by holistically caring for the mind, body, and spirit of breastfeeding mothers. Hypnobreastfeeding produces positive feedback by making the mother more relaxed, calm, and comfortable during breastfeeding, that is, an increase in the release of oxytocin and prolactin by the pituitary. In the hypnobreastfeeding philosophy, affirmation, relaxation, imagination, and visualization positively affect the subconscious. When the positive affirmations provided by hypnobreastfeeding are placed in the subconscious, they automatically affect daily life and actions and increase mothers' self-confidence. Therefore, hypnobreastfeeding is suitable for creating positive intention and motivation in breastfeeding, reducing anxiety and stress, maximizing the amount and quality of breast milk, increasing mother-baby bonding, and accelerating the involution process.
- Conditions
- Breastfeeding, Exclusive, Nurse's Role, Self Efficacy
- Being tested
- Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources
- Keywords
- Breastfeeding Self-Efficacy, Breastfeeding Outcomes, Social Support Perception, Nurse, Breastfeeding self-efficacy theory, Hypnobreastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy ResourcesBehavioural
Breastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program (EMÖZGEDAP) was developed based on Denis's Breastfeeding Self-Efficacy theory along with the hypnobreastfeeding philosophy. In the individual counseling program focusing on the philosophy of hypnobreastfeeding, it will be emphasized that breastfeeding is an intuitive, natural, and unique process. Techniques such as affirmations, breathing exercises, relaxation, endorphin, serotonin, and oxytocin-enhancing practices will be used. Concepts from Dennis' breastfeeding self-efficacy theory will be integrated into the training program. The individual counseling program will be carried out by adult education criteria, methods such as slide presentation, three-dimensional models, video, role-play, peer opinions with positive breastfeeding experiences, case discussion, and question and answer will be used.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will not receive individual counseling; they will go through the hospital's routine monitoring and counseling process. |
| Intervention Group | Experimental | Individual counseling will be provided to the intervention group within the scope of the Breastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program (EMÖZGEDAP), based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). Receives: Behavioral: Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding and Nutrition Results
This form was prepared based on Labbok \& Krosovec's classification (Labbok \& Krasovec, 1990). It enables the evaluation of the characteristics of the baby's breastfeeding or feeding as complete, partial, and symbolic breastfeeding.
Measured: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Antenatal Breastfeeding Self-Efficacy Scale Short Form
The Breastfeeding Self-Efficacy Scale was developed by Dennis in 2003. Aluş Tokat, Okumus, and Dennis (2010) started to study the Turkish reliability standard of the Short Form of the Breastfeeding Self-Efficacy Scale. It is used to evaluate how competent pregnant women feel about breastfeeding. The scale, consisting of 14 items, is assessed on a 5-point Likert type. There are no reverse-scored items in the scale. A minimum of 14 points and a maximum of 70 points are obtained from the scale. A high score on the scale means that breastfeeding self-efficacy is also high (Dennis and Faux, 1999).
Measured: This form will be administered to pregnant women at 28 weeks of gestation before the intervention.
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
Dennis developed the Breastfeeding Self-Efficacy Scale. Aluş Tokat, Okumus, and Dennis (2010) started to study the Turkish reliability standard of the Short Form of the Breastfeeding Self-Efficacy Scale. It is used to evaluate how competent postpartum mothers feel about breastfeeding postpartum. The scale, consisting of 14 items, is assessed on a 5-point Likert type. There are no reverse-scored items in the scale. A minimum of 14 points and a maximum of 70 points are obtained from the scale. A high score on the scale means that breastfeeding self-efficacy is also high (Dennis and Faux, 1999).
Measured: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Breastfeeding Self-Efficacy Scale for Fathers Short Form
It was developed by Dennis, Brennenstuhl, and Abbass-Dick (2018) to evaluate fathers' perspectives and impact on breastfeeding. Its Turkish validity and reliability were tested by Küçükoğlu, Kurt Sezer, and Dennis in 2019. The scale, which can be applied to all fathers with newborns and breastfed babies, is a 5-point scale with no reverse-scored items. The lowest score is 14, and the highest score is 70 from the one-dimensional 14-item scale, and as the score increases, self-efficacy increases.
Measured: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy
This scale evaluates the mother's perception of support for breastfeeding self-efficacy provided by close others. The scale consisting of 14 items is a 4-point Likert type. Researchers and Dennis are developing it as part of her doctoral thesis.
Measured: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy
This scale evaluates the close others 's perception of support for breastfeeding self-efficacy. The scale consisting of 14 items is a 4-point Likert type. Researchers and Dennis are developing it as part of her doctoral thesis.
Measured: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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 randomized controlled experimental study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hümeyra TÜLEK DENİZ, Ondokuz Mayıs University
- Investigators
- Özen KULAKAÇ, Professor, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266806
- Sponsor's protocol ID
- OndokusMU55
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
PubMed 18541350Beake S, Bick D, Narracott C, Chang YS. Interventions for women who have a caesarean birth to increase uptake and duration of breastfeeding: A systematic review. Matern Child Nutr. 2017 Oct;13(4):e12390. doi: 10.1111/mcn.12390. Epub 2016 Nov 24.
PubMed 27882659Mizrak Sahin B, Ozerdogan N, Ozdamar K, Gursoy E. Factors affecting breastfeeding motivation in primiparious mothers: An application of breastfeeding motivation scale based on self-determination theory. Health Care Women Int. 2019 Jun;40(6):637-652. doi: 10.1080/07399332.2018.1526289. Epub 2019 May 29.
PubMed 31140955Bezner Kerr R, Dakishoni L, Shumba L, Msachi R, Chirwa M. "We grandmothers know plenty": breastfeeding, complementary feeding and the multifaceted role of grandmothers in Malawi. Soc Sci Med. 2008 Mar;66(5):1095-105. doi: 10.1016/j.socscimed.2007.11.019. Epub 2007 Dec 21.
PubMed 18155334Blyth R, Creedy DK, Dennis CL, Moyle W, Pratt J, De Vries SM. Effect of maternal confidence on breastfeeding duration: an application of breastfeeding self-efficacy theory. Birth. 2002 Dec;29(4):278-84. doi: 10.1046/j.1523-536x.2002.00202.x.
PubMed 12484390Bootsri W, Taneepanichskul S. Effectiveness of experiential learning with empowerment strategies and social support from grandmothers on breastfeeding among Thai adolescent mothers. Int Breastfeed J. 2017 Aug 22;12:37. doi: 10.1186/s13006-017-0128-7. eCollection 2017.
PubMed 28852416Brockway M, Benzies K, Hayden KA. Interventions to Improve Breastfeeding Self-Efficacy and Resultant Breastfeeding Rates: A Systematic Review and Meta-Analysis. J Hum Lact. 2017 Aug;33(3):486-499. doi: 10.1177/0890334417707957. Epub 2017 Jun 23.
PubMed 28644764Chan MY, Ip WY, Choi KC. The effect of a self-efficacy-based educational programme on maternal breast feeding self-efficacy, breast feeding duration and exclusive breast feeding rates: A longitudinal study. Midwifery. 2016 May;36:92-8. doi: 10.1016/j.midw.2016.03.003. Epub 2016 Mar 8.
PubMed 27106949Cangol E, Sahin NH. The Effect of a Breastfeeding Motivation Program Maintained During Pregnancy on Supporting Breastfeeding: A Randomized Controlled Trial. Breastfeed Med. 2017 May;12:218-226. doi: 10.1089/bfm.2016.0190. Epub 2017 Mar 13.
PubMed 28287819Chipojola R, Chiu HY, Huda MH, Lin YM, Kuo SY. Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Sep;109:103675. doi: 10.1016/j.ijnurstu.2020.103675. Epub 2020 Jun 6.
PubMed 32585447Chipojola R, Khwepeya M, Gondwe KW, Rias YA, Huda MH. The Influence of Breastfeeding Promotion Programs on Exclusive Breastfeeding Rates in Sub-Saharan Africa: A Systematic Review and Meta-Analysis. J Hum Lact. 2022 Aug;38(3):466-476. doi: 10.1177/08903344221097689. Epub 2022 Jun 9.
PubMed 35684942Citak Bilgin N, Ak B, Ayhan F, Kocyigit F, Yorgun S, Topcuoglu MA. Effect of childbirth education on the perceptions of childbirth and breastfeeding self-efficacy and the obstetric outcomes of nulliparous women*,**,**. Health Care Women Int. 2020 Feb;41(2):188-204. doi: 10.1080/07399332.2019.1672171. Epub 2019 Sep 30.
PubMed 31567051Corbett CA, Callister LC. Giving birth: the voices of women in Tamil Nadu, India. MCN Am J Matern Child Nurs. 2012 Sep;37(5):298-305; quiz 306-7. doi: 10.1097/NMC.0b013e318252ba4d.
PubMed 22751471Dennis CL, Brennenstuhl S, Abbass-Dick J. Measuring paternal breastfeeding self-efficacy: A psychometric evaluation of the Breastfeeding Self-Efficacy Scale-Short Form among fathers. Midwifery. 2018 Sep;64:17-22. doi: 10.1016/j.midw.2018.05.005. Epub 2018 May 15.
PubMed 29864577Gharaei T, Amiri-Farahani L, Haghani S, Hasanpoor-Azghady SB. The effect of breastfeeding education with grandmothers' attendance on breastfeeding self-efficacy and infant feeding pattern in Iranian primiparous women: a quasi-experimental pilot study. Int Breastfeed J. 2020 Oct 12;15(1):84. doi: 10.1186/s13006-020-00325-5.
PubMed 33046115
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Theory-Based Breastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes
- ClinicalTrials.gov ID
- NCT06266806
- Acronym / sponsor ID
- OndokusMU55
- Conditions
- Breastfeeding, Exclusive, Nurse's Role, Self Efficacy
- Keywords
- Breastfeeding Self-Efficacy, Breastfeeding Outcomes, Social Support Perception, Nurse, Breastfeeding self-efficacy theory, Hypnobreastfeeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Feb 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 purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception, breastfeeding self-efficacy and outcomes. The study will involve pregnant women and close others assigned randomly to the intervention (n=50) or control (n=50) groups in a state hospital in Turkey. Individual counseling will be provided to the intervention group within the scope of the EMÖZGEDAP, based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). The Antenatal Breastfeeding Self-Efficacy Scale will be evaluated before the counseling program is given in the antepartum period. Breastfeeding and Nutrition Results, Postpartum Breastfeeding Self-Efficacy Scale, Breastfeeding Self-Efficacy Scale for Fathers, Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy and Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy will be evaluated at the 1st, 3rd, and 6th months postpartum.
Detailed description
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that babies start breastfeeding within the first hour after birth and be exclusively breastfed for the first six months. In this situation, the baby is not given any other food or liquid, including water, defined as "full breastfeeding." Breastfeeding schemes were developed by Labbok and Krosovec in 1990 to ensure consistency in research. According to this scheme, breastfeeding methods are divided into full, partial, and symbolic, according to the baby's nutritional characteristics. According to the Turkey Demographic and Health Survey (TNSA, 2018) data, 98% of children are breastfed at some point, and 42% receive food other than breast milk in the pre-lacteal (before breastfeeding) period. In Turkey, 71% of children under two are breastfed within the first hour after birth, and only 41% of babies under six months are exclusively breastfed.
Self-efficacy is an essential factor in breastfeeding at the desired level. Influenced by Bandura's definition of self-efficacy, Cindy-Lee Dennis developed the "Breastfeeding Self-Efficacy Theory" by identifying the sources and influencing factors of Breastfeeding Self-Efficacy Perception. According to Dennis and Faux, a mother's breastfeeding self-efficacy includes whether she breastfeeds her baby, how much time she spends caring for her baby, her thoughts about breastfeeding, and her ability to cope with emotional difficulties during breastfeeding. Mothers with high self-efficacy encourage themselves to face challenges and try to solve events by thinking positively. These mothers prefer breastfeeding more, are more courageous, and act ultimately when they experience difficulties. Mother's breastfeeding self-efficacy is affected by four primary sources of information: The mother's previous experiences regarding breastfeeding, the examples the mother sees from others regarding breastfeeding, the support of the environment regarding breastfeeding, and the mother's psychological state regarding breastfeeding. Healthcare personnel should influence these factors to improve self-efficacy. Maternal breastfeeding self-efficacy has been identified as an important modifiable factor for successful breastfeeding.
Various factors, such as breastfeeding self-efficacy and social support, affect the sustainability of breastfeeding. The studies stated that social and especially spousal support is adequate for successful breastfeeding and the mother's decision to breastfeed early at birth. According to some studies, those with more social support have higher breastfeeding self-efficacy rates. The studies emphasized that family support is an essential factor in encouraging breastfeeding. The failure of family members to provide adequate breastfeeding support and information to women resulted in the use of formula. It is stated that the older generation, especially the baby's grandmother or paternal grandmother, plays a central role in various aspects of pregnancy decision-making and child-rearing within the family structure. A study conducted among mothers-in-law in Nepal found that mothers-in-law "view themselves as key providers and decision makers of perinatal care practices." Therefore, the woman needs to receive support from her social circle through participation and encouragement during breastfeeding.
Hypnobreastfeeding is a relaxation technique that helps improve the breastfeeding process by holistically caring for the mind, body, and spirit of breastfeeding mothers. Hypnobreastfeeding produces positive feedback by making the mother more relaxed, calm, and comfortable during breastfeeding, that is, an increase in the release of oxytocin and prolactin by the pituitary. In the hypnobreastfeeding philosophy, affirmation, relaxation, imagination, and visualization positively affect the subconscious. When the positive affirmations provided by hypnobreastfeeding are placed in the subconscious, they automatically affect daily life and actions and increase mothers' self-confidence. Therefore, hypnobreastfeeding is suitable for creating positive intention and motivation in breastfeeding, reducing anxiety and stress, maximizing the amount and quality of breast milk, increasing mother-baby bonding, and accelerating the involution process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will not receive individual counseling; they will go through the hospital's routine monitoring and counseling process. |
| Intervention Group | Experimental | Behavioral: Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy ResourcesIndividual counseling will be provided to the intervention group within the scope of the Breastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program (EMÖZGEDAP), based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being 18 years or older,
- 28-37. be between weeks,
- Being primiparous,
- Having a healthy singleton pregnancy,
- Being at least a primary school graduate,
Key exclusion criteria (5 listed)
- Not filling out the forms in the study or filling them incompletely,
- The participant wishes to leave the research,
- The emergence of a condition that prevents breastfeeding in the mother and baby,
- Moving from the city where the work is done or moving out of the town,
- Family support is for less than 1 month,
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 |
|---|---|---|
| Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy ResourcesBreastfeeding Self-Efficacy Resources Developing Nurse Consultancy Program (EMÖZGEDAP) was developed based on Denis's Breastfeeding Self-Efficacy theory along with the hypnobreastfeeding philosophy. In the individual counseling program focusing on the philosophy of hypnobreastfeeding, it will be emphasized that breastfeeding is an intuitive, natural, and unique process. Techniques such as affirmations, breathing exercises, relaxation, endorphin, serotonin, and oxytocin-enhancing practices will be used. Concepts from Dennis' breastfeeding self-efficacy theory will be integrated into the training program. The individual counseling program will be carried out by adult education criteria, methods such as slide presentation, three-dimensional models, video, role-play, peer opinions with positive breastfeeding experiences, case discussion, and question and answer will be used. | Behavioural | Intervention Group |
Primary outcome
Breastfeeding and Nutrition Results
Time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
This form was prepared based on Labbok \& Krosovec's classification (Labbok \& Krasovec, 1990). It enables the evaluation of the characteristics of the baby's breastfeeding or feeding as complete, partial, and symbolic breastfeeding.
Antenatal Breastfeeding Self-Efficacy Scale Short Form
Time frame: This form will be administered to pregnant women at 28 weeks of gestation before the intervention.
The Breastfeeding Self-Efficacy Scale was developed by Dennis in 2003. Aluş Tokat, Okumus, and Dennis (2010) started to study the Turkish reliability standard of the Short Form of the Breastfeeding Self-Efficacy Scale. It is used to evaluate how competent pregnant women feel about breastfeeding. The scale, consisting of 14 items, is assessed on a 5-point Likert type. There are no reverse-scored items in the scale. A minimum of 14 points and a maximum of 70 points are obtained from the scale. A high score on the scale means that breastfeeding self-efficacy is also high (Dennis and Faux, 1999).
Postpartum Breastfeeding Self-Efficacy Scale-Short Form
Time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Dennis developed the Breastfeeding Self-Efficacy Scale. Aluş Tokat, Okumus, and Dennis (2010) started to study the Turkish reliability standard of the Short Form of the Breastfeeding Self-Efficacy Scale. It is used to evaluate how competent postpartum mothers feel about breastfeeding postpartum. The scale, consisting of 14 items, is assessed on a 5-point Likert type. There are no reverse-scored items in the scale. A minimum of 14 points and a maximum of 70 points are obtained from the scale. A high score on the scale means that breastfeeding self-efficacy is also high (Dennis and Faux, 1999).
Breastfeeding Self-Efficacy Scale for Fathers Short Form
Time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
It was developed by Dennis, Brennenstuhl, and Abbass-Dick (2018) to evaluate fathers' perspectives and impact on breastfeeding. Its Turkish validity and reliability were tested by Küçükoğlu, Kurt Sezer, and Dennis in 2019. The scale, which can be applied to all fathers with newborns and breastfed babies, is a 5-point scale with no reverse-scored items. The lowest score is 14, and the highest score is 70 from the one-dimensional 14-item scale, and as the score increases, self-efficacy increases.
Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy
Time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
This scale evaluates the mother's perception of support for breastfeeding self-efficacy provided by close others. The scale consisting of 14 items is a 4-point Likert type. Researchers and Dennis are developing it as part of her doctoral thesis.
Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy
Time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
This scale evaluates the close others 's perception of support for breastfeeding self-efficacy. The scale consisting of 14 items is a 4-point Likert type. Researchers and Dennis are developing it as part of her doctoral thesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 18541350Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
- Background: PubMed 27882659Beake S, Bick D, Narracott C, Chang YS. Interventions for women who have a caesarean birth to increase uptake and duration of breastfeeding: A systematic review. Matern Child Nutr. 2017 Oct;13(4):e12390. doi: 10.1111/mcn.12390. Epub 2016 Nov 24.
- Background: PubMed 31140955Mizrak Sahin B, Ozerdogan N, Ozdamar K, Gursoy E. Factors affecting breastfeeding motivation in primiparious mothers: An application of breastfeeding motivation scale based on self-determination theory. Health Care Women Int. 2019 Jun;40(6):637-652. doi: 10.1080/07399332.2018.1526289. Epub 2019 May 29.
- Background: PubMed 18155334Bezner Kerr R, Dakishoni L, Shumba L, Msachi R, Chirwa M. "We grandmothers know plenty": breastfeeding, complementary feeding and the multifaceted role of grandmothers in Malawi. Soc Sci Med. 2008 Mar;66(5):1095-105. doi: 10.1016/j.socscimed.2007.11.019. Epub 2007 Dec 21.
- Background: PubMed 12484390Blyth R, Creedy DK, Dennis CL, Moyle W, Pratt J, De Vries SM. Effect of maternal confidence on breastfeeding duration: an application of breastfeeding self-efficacy theory. Birth. 2002 Dec;29(4):278-84. doi: 10.1046/j.1523-536x.2002.00202.x.
- Background: PubMed 28852416Bootsri W, Taneepanichskul S. Effectiveness of experiential learning with empowerment strategies and social support from grandmothers on breastfeeding among Thai adolescent mothers. Int Breastfeed J. 2017 Aug 22;12:37. doi: 10.1186/s13006-017-0128-7. eCollection 2017.
- Background: PubMed 28644764Brockway M, Benzies K, Hayden KA. Interventions to Improve Breastfeeding Self-Efficacy and Resultant Breastfeeding Rates: A Systematic Review and Meta-Analysis. J Hum Lact. 2017 Aug;33(3):486-499. doi: 10.1177/0890334417707957. Epub 2017 Jun 23.
- Background: PubMed 27106949Chan MY, Ip WY, Choi KC. The effect of a self-efficacy-based educational programme on maternal breast feeding self-efficacy, breast feeding duration and exclusive breast feeding rates: A longitudinal study. Midwifery. 2016 May;36:92-8. doi: 10.1016/j.midw.2016.03.003. Epub 2016 Mar 8.
- Background: PubMed 28287819Cangol E, Sahin NH. The Effect of a Breastfeeding Motivation Program Maintained During Pregnancy on Supporting Breastfeeding: A Randomized Controlled Trial. Breastfeed Med. 2017 May;12:218-226. doi: 10.1089/bfm.2016.0190. Epub 2017 Mar 13.
- Background: PubMed 32585447Chipojola R, Chiu HY, Huda MH, Lin YM, Kuo SY. Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Sep;109:103675. doi: 10.1016/j.ijnurstu.2020.103675. Epub 2020 Jun 6.
- Background: PubMed 35684942Chipojola R, Khwepeya M, Gondwe KW, Rias YA, Huda MH. The Influence of Breastfeeding Promotion Programs on Exclusive Breastfeeding Rates in Sub-Saharan Africa: A Systematic Review and Meta-Analysis. J Hum Lact. 2022 Aug;38(3):466-476. doi: 10.1177/08903344221097689. Epub 2022 Jun 9.
- Background: PubMed 31567051Citak Bilgin N, Ak B, Ayhan F, Kocyigit F, Yorgun S, Topcuoglu MA. Effect of childbirth education on the perceptions of childbirth and breastfeeding self-efficacy and the obstetric outcomes of nulliparous women*,,. Health Care Women Int. 2020 Feb;41(2):188-204. doi: 10.1080/07399332.2019.1672171. Epub 2019 Sep 30.
- Türkiye Nüfus ve Sağlık Araştırmaları (2018)Link provided by the sponsor.
- World Health Organisation. 2013. Long-term Effects of Breastfeeding: A Systematic Review.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Özen KULAKAÇ, Professor study director
Ondokuz Mayıs 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 Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources in people with Breastfeeding, Exclusive and Nurse's Role, run by Ondokuz Mayıs 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hümeyra TÜLEK DENİZ, MSc (0 474 242 68 40 ext. 5035, humeyra.tulek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding and Nutrition Results (time frame: This form will be evaluated at the 1st, 3rd, and 6th months postpartum.). The study lists 6 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 NCT06266806, which also lists 23 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 20 Mar 2025.