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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06266806
Other study ID # OndokusMU55
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 26, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Ondokuz Mayis University
Contact Hümeyra TÜLEK DENIZ, MSc
Phone 0 474 242 68 40
Email humeyra.tulek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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.), Exclusion Criteria: - 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,

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

References & Publications (23)

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. — View Citation

Beake 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. — View Citation

Bezner 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. — View Citation

Blyth 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. — View Citation

Bootsri 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. — View Citation

Brockway 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. — View Citation

Cangol 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. — View Citation

Chan 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. — View Citation

Chipojola 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. — View Citation

Chipojola 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. — View Citation

Citak 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. — View Citation

Corbett 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. — View Citation

Dennis 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. — View Citation

Gharaei 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. — View Citation

Kucukoglu S, Sezer HK, Dennis CL. Validity and reliability of the Turkish version of the paternal breastfeeding self-efficacy scale - Short form for fathers. Midwifery. 2023 Jan;116:103513. doi: 10.1016/j.midw.2022.103513. Epub 2022 Oct 22. — View Citation

Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30. — View Citation

Maleki A, Faghihzadeh E, Youseflu S. The Effect of Educational Intervention on Improvement of Breastfeeding Self-Efficacy: A Systematic Review and Meta-Analysis. Obstet Gynecol Int. 2021 Aug 10;2021:5522229. doi: 10.1155/2021/5522229. eCollection 2021. — View Citation

Masvie H. The role of Tamang mothers-in-law in promoting breast feeding in Makwanpur District, Nepal. Midwifery. 2006 Mar;22(1):23-31. doi: 10.1016/j.midw.2005.02.003. Epub 2005 Jun 20. — View Citation

Mizrak 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. — View Citation

Negin J, Coffman J, Vizintin P, Raynes-Greenow C. The influence of grandmothers on breastfeeding rates: a systematic review. BMC Pregnancy Childbirth. 2016 Apr 27;16:91. doi: 10.1186/s12884-016-0880-5. — View Citation

Otsuka K, Dennis CL, Tatsuoka H, Jimba M. The relationship between breastfeeding self-efficacy and perceived insufficient milk among Japanese mothers. J Obstet Gynecol Neonatal Nurs. 2008 Sep-Oct;37(5):546-55. doi: 10.1111/j.1552-6909.2008.00277.x. — View Citation

Tarrant M, Dodgson JE, Wu KM. Factors contributing to early breast-feeding cessation among Chinese mothers: an exploratory study. Midwifery. 2014 Oct;30(10):1088-95. doi: 10.1016/j.midw.2014.03.002. Epub 2014 Mar 12. — View Citation

Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Primary Antenatal Breastfeeding Self-Efficacy Scale Short Form The Breastfeeding Self-Efficacy Scale was developed by Dennis in 2003. Alus 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). This form will be administered to pregnant women at 28 weeks of gestation before the intervention.
Primary Postpartum Breastfeeding Self-Efficacy Scale-Short Form Dennis developed the Breastfeeding Self-Efficacy Scale. Alus 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). This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Primary 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 Küçükoglu, 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. This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Primary 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. This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
Primary 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. This form will be evaluated at the 1st, 3rd, and 6th months postpartum.
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