NCT05246748

Brief Summary

It is a randomized controlled prospective study. The purpose of the study is to examine the effect of breastfeeding education and support program based on Human Caring Theory (HCT) on mothers' breastfeeding self-efficacy, duration and definitions, and their satisfaction with this process. As a result, Human Caring Theory based breastfeeding education program improved breastfeeding self-efficacy, duration and exclusive breastfeeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

January 21, 2022

Last Update Submit

February 18, 2022

Conditions

Keywords

Theory of Human CaringBreastfeedingNursingSelf-efficacy

Outcome Measures

Primary Outcomes (4)

  • BREASTFEEDİNG SELF-EFFİCACY

    BREASTFEEDİNG SELF-EFFİCACY SCORE

    Change from breastfeeding self-efficacy at 6 months

  • BREASTFEEDİNG DURATION

    HOW LONG BREASTFEEDİNG CONTİNUES

    Change from breastfeeding duration at 6 months

  • THE BABY FEEDİNG DEFİNİTİON FORM

    EXPLAINS THE TYPE OF BREASTFEEDING.SUCH AS EXCLUSİVE BREASTFEEDİNG OR PARİTAL BREASTFEEDİNG ETC.

    Change from the babies breastfeeding definition at 6 months

  • WATSON CARİTAS PATİENT SCORE

    DETERMINES WOMEN'S SATISFACTION LEVELS WITH THE EDUCATION THEY RECEIVE. IN THIS STUDY, MOTHERS WITH HIGH WATSON CARITAS PATIENT SCORES ALSO HAVE HIGH LEVELS OF SATISFACTION WITH THE EDUCATION PROCESS.

    1 week

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period.

Other: Human Caring Theory based Education

Control group

ACTIVE COMPARATOR

The control group received solely standard education program for one sessions in prenatal period.

Other: Standard Education

Interventions

The intervention group was given a breastfeeding education program based on the HCT for six face to face sessionconducted in parallel with asynchronous distance education sessions in prenatal period and continued with web based sessions and telephone support in postnatal period.

Intervention group

The control group received solely standard education program for one sessions in prenatal period.

Control group

Eligibility Criteria

Age19 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous women with 28-34 weeks of pregnancy able to speak and understand Turkish without any communication barrier were

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamze DURMAZOĞLU

Izmir, Turkey (Türkiye)

Location

Related Publications (34)

  • Almohanna AA, Win KT, Meedya S. Effectiveness of Internet-Based Electronic Technology Interventions on Breastfeeding Outcomes: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17361. doi: 10.2196/17361.

    PMID: 32469315BACKGROUND
  • 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
  • Arslan-Ozkan I, Okumus H, Buldukoglu K. A randomized controlled trial of the effects of nursing care based on Watson's Theory of Human Caring on distress, self-efficacy and adjustment in infertile women. J Adv Nurs. 2014 Aug;70(8):1801-12. doi: 10.1111/jan.12338. Epub 2013 Dec 22.

    PMID: 24372443BACKGROUND
  • Bai YK, Lee S, Overgaard K. Critical Review of Theory Use in Breastfeeding Interventions. J Hum Lact. 2019 Aug;35(3):478-500. doi: 10.1177/0890334419850822. Epub 2019 May 17.

    PMID: 31100027BACKGROUND
  • Bensley RJ, Hovis A, Horton KD, Loyo JJ, Bensley KM, Phillips D, Desmangles C. Accessibility and preferred use of online Web applications among WIC participants with Internet access. J Nutr Educ Behav. 2014 May-Jun;46(3 Suppl):S87-92. doi: 10.1016/j.jneb.2014.02.007.

    PMID: 24810002BACKGROUND
  • Boateng GO, Martin SL, Tuthill EL, Collins SM, Dennis CL, Natamba BK, Young SL. Adaptation and psychometric evaluation of the breastfeeding self-efficacy scale to assess exclusive breastfeeding. BMC Pregnancy Childbirth. 2019 Feb 18;19(1):73. doi: 10.1186/s12884-019-2217-7.

    PMID: 30777020BACKGROUND
  • Brewer BB, Watson J. Evaluation of Authentic Human Caring Professional Practices. J Nurs Adm. 2015 Dec;45(12):622-7. doi: 10.1097/NNA.0000000000000275.

    PMID: 26502069BACKGROUND
  • 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
  • Cangöl, E., Hotun Şahin, N. (2017). A Model of Breastfeeding Support: Motivational Interviews Based On Pender's Health Promotion Model. HJournal of Education and Research in Nursing, 14 (1), 98-103. doi: 10.5222/HEAD.2017.098

    BACKGROUND
  • 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
  • Chauhan SP, Blackwell SC, Saade GR; Society for Maternal-Fetal Medicine Health Policy Committee. A suggested approach for implementing CONSORT guidelines specific to obstetric research. Obstet Gynecol. 2013 Nov;122(5):952-956. doi: 10.1097/AOG.0b013e3182a9c9af.

    PMID: 24104788BACKGROUND
  • 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
  • Dennis CL. Identifying predictors of breastfeeding self-efficacy in the immediate postpartum period. Res Nurs Health. 2006 Aug;29(4):256-68. doi: 10.1002/nur.20140.

    PMID: 16847899BACKGROUND
  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PMID: 14649593BACKGROUND
  • Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.

    PMID: 10578797BACKGROUND
  • Diji AK, Bam V, Asante E, Lomotey AY, Yeboah S, Owusu HA. Challenges and predictors of exclusive breastfeeding among mothers attending the child welfare clinic at a regional hospital in Ghana: a descriptive cross-sectional study. Int Breastfeed J. 2017 Mar 9;12:13. doi: 10.1186/s13006-017-0104-2. eCollection 2016.

    PMID: 28286540BACKGROUND
  • Durmazoglu G, Yenal K, Okumus H. Maternal Emotions and Experiences of Mothers Who Had Breastfeeding Problems: A Qualitative Study. Res Theory Nurs Pract. 2020 Jan 1;34(1):3-20. doi: 10.1891/1541-6577.34.1.3.

    PMID: 31937633BACKGROUND
  • Finfgeld-Connett D. Meta-synthesis of caring in nursing. J Clin Nurs. 2008 Jan;17(2):196-204. doi: 10.1111/j.1365-2702.2006.01824.x. Epub 2007 Mar 1.

    PMID: 17331089BACKGROUND
  • Gu Y, Zhu Y, Zhang Z, Wan H. Effectiveness of a theory-based breastfeeding promotion intervention on exclusive breastfeeding in China: A randomised controlled trial. Midwifery. 2016 Nov;42:93-99. doi: 10.1016/j.midw.2016.09.010. Epub 2016 Sep 22.

    PMID: 27788416BACKGROUND
  • Khorshidifard, M., Amini, M., Dehghani, M.R., Zaree, N., et al. (2017). 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, 4(3), 2-6.doi: 10.5812/WHB.41919

    BACKGROUND
  • Kim SK, Park S, Oh J, Kim J, Ahn S. Interventions promoting exclusive breastfeeding up to six months after birth: A systematic review and meta-analysis of randomized controlled trials. Int J Nurs Stud. 2018 Apr;80:94-105. doi: 10.1016/j.ijnurstu.2018.01.004. Epub 2018 Jan 12.

    PMID: 29407349BACKGROUND
  • Koskinen KS, Aho AL, Hannula L, Kaunonen M. Maternity hospital practices and breast feeding self-efficacy in Finnish primiparous and multiparous women during the immediate postpartum period. Midwifery. 2014 Apr;30(4):464-70. doi: 10.1016/j.midw.2013.05.003. Epub 2013 Jun 13.

    PMID: 23768951BACKGROUND
  • Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann. 1990 Jul-Aug;21(4):226-30.

    PMID: 2219227BACKGROUND
  • Lau CYK, Lok KYW, Tarrant M. Breastfeeding Duration and the Theory of Planned Behavior and Breastfeeding Self-Efficacy Framework: A Systematic Review of Observational Studies. Matern Child Health J. 2018 Mar;22(3):327-342. doi: 10.1007/s10995-018-2453-x.

    PMID: 29427014BACKGROUND
  • Lewkowitz AK, Cahill AG. Mobile Health Approaches to Breastfeeding. Clin Obstet Gynecol. 2021 Jun 1;64(2):384-391. doi: 10.1097/GRF.0000000000000606.

    PMID: 33813523BACKGROUND
  • Loke AY, Chan LK. Maternal breastfeeding self-efficacy and the breastfeeding behaviors of newborns in the practice of exclusive breastfeeding. J Obstet Gynecol Neonatal Nurs. 2013 Nov-Dec;42(6):672-84. doi: 10.1111/1552-6909.12250. Epub 2013 Oct 15.

    PMID: 24128113BACKGROUND
  • Ozan, Y.D., Okumuş, H. (2013). Nursing Care of Women with Unsuccessful Infertility Treatment According to Watson's Theory of Caring. Anatolian Journal of Nursing and Health Sciences, 16, 3.

    BACKGROUND
  • Özkara, H., Fidancı, B.E., Yıldız, D., Kaymakamgil, Ç. (2016). Lactation consult. TAF Preventive Medicine Bulletin, 15(6), 551- 555. doi: 10.5455/pmb.1-1436701913

    BACKGROUND
  • Parry KC, Tully KP, Hopper LN, Schildkamp PE, Labbok MH. Evaluation of Ready, Set, BABY: A prenatal breastfeeding education and counseling approach. Birth. 2019 Mar;46(1):113-120. doi: 10.1111/birt.12393. Epub 2018 Sep 6.

    PMID: 30191591BACKGROUND
  • Şengün, F., Üstün, B., & Bademli, K. (2013). Exploration of Theory/Model Based Nursıng Research In Turkey. Anatolian Journal of Nursing and Health Sciences, 16(2), 132-139.

    BACKGROUND
  • Tokat, M.A., & Okumus, H. (2013). Mothers Breastfeeding Self-Efficacy and Success: Analysis The Effect of Education Based on Improving Breastfeeding Self-Efficacy. Journal of Education and Research in Nursing, 10(1), 21-29.

    BACKGROUND
  • Tseng JF, Chen SR, Au HK, Chipojola R, Lee GT, Lee PH, Shyu ML, Kuo SY. Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study. Int J Nurs Stud. 2020 Nov;111:103770. doi: 10.1016/j.ijnurstu.2020.103770. Epub 2020 Sep 3.

    PMID: 32961461BACKGROUND
  • van Dellen SA, Wisse B, Mobach MP, Dijkstra A. The effect of a breastfeeding support programme on breastfeeding duration and exclusivity: a quasi-experiment. BMC Public Health. 2019 Jul 24;19(1):993. doi: 10.1186/s12889-019-7331-y.

    PMID: 31340787BACKGROUND
  • Watson, J., Brewer, B.B., D'Alfonso, J. (2010). Watson caritas patient score (WCPS). Watson Caring Science Institute: Boulder, CO. Accessed: www.watsoncaringscience.org Last accessed: 27.11.2021

    BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 18, 2022

Study Start

January 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Starting after publication
Access Criteria
Researchers who study for women and child health can review requests and criteria for reviewing requests may also be provided.

Locations