NCT06266806

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 20, 2025

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

February 11, 2024

Last Update Submit

March 19, 2025

Conditions

Keywords

Breastfeeding Self-EfficacyBreastfeeding OutcomesSocial Support PerceptionNurseBreastfeeding self-efficacy theoryHypnobreastfeeding

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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).

    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).

    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.

    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.

    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.

    This form will be evaluated at the 1st, 3rd, and 6th months postpartum.

Study Arms (2)

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).

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older,
  • 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.),

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kars Harakani State Hospital

Kars, Center, 36100, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 18541350BACKGROUND
  • 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.

    PMID: 27882659BACKGROUND
  • 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.

    PMID: 31140955BACKGROUND
  • 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.

    PMID: 18155334BACKGROUND
  • 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.

    PMID: 12484390BACKGROUND
  • 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.

    PMID: 28852416BACKGROUND
  • 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.

    PMID: 28644764BACKGROUND
  • 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.

    PMID: 27106949BACKGROUND
  • 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.

    PMID: 28287819BACKGROUND
  • 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.

    PMID: 32585447BACKGROUND
  • 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.

    PMID: 35684942BACKGROUND
  • 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.

    PMID: 31567051BACKGROUND
  • 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.

    PMID: 22751471BACKGROUND
  • 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.

    PMID: 29864577BACKGROUND
  • 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.

    PMID: 33046115BACKGROUND
  • 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.

    PMID: 27121708BACKGROUND
  • 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.

    PMID: 36323075BACKGROUND
  • 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.

    PMID: 24703632BACKGROUND
  • 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.

    PMID: 24252711BACKGROUND
  • 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.

    PMID: 15967547BACKGROUND
  • 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.

    PMID: 34422058BACKGROUND
  • Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.

    PMID: 2219227BACKGROUND
  • 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.

    PMID: 18811774BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Özen KULAKAÇ, Professor

    Ondokuz Mayıs University

    STUDY DIRECTOR

Central Study Contacts

Hümeyra TÜLEK DENİZ, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 20, 2024

Study Start

July 15, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

March 20, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Article Access
Article Access
Article Access
Article Access
Thesis Access
Article Access
Article Access

Locations