Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

NCT05593536 | Completed

• 1 other identifier: 2022/84
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This study was randomized to determine the effect of biological nurturing education given to nulliparous pregnant women on breastfeeding status. Method: The population of the study consisted of pregnant women who are visiting Istanbul Training and Research Hospital Suleymaniye Obstetrics and Pediatrics Hospital between October 2022 and August 2023. F test at 90% effect power 0.25 medium effect level on the sample of the study analyzed using the Gpower (3.1.9.2) Programe. As a result of the analyze, it was planned to recruit 207 nulliparous pregnant women. According to the calculation made, there should be at least 69 people in each groups. Accordingly, 69 people in the experimental 1 group (biological nurturing), 69 people in the experimental 2 group (classical breastfeeding), 69 people should be included in the control group. Experimental 1 group and experimental 2 group will be given breastfeeding training on their first visit and after two weeks. Breastfeeding success in the postpartum period will be compared in all groups.

Conditions

Breastfeeding

Keywords

biological nurturing; breastfeeding; education

Outcome Measures

Primary Outcomes (3)

• Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group

  Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.

  Two weeks after the first training

• Higher ''Prenatal Breastfeeding Self-Efficacy Scale'' score in the biological nurturing group

  Prenatal Breastfeeding Self-Efficacy Scale was developed to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The lowest score is 20, the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.

  The first 24 hours of the postpartum period

• Higher ''LATCH Scale'' score in the biological nurturing group

  LATCH Scale is an assessment tool to evaluate the effectiveness of early breast-feeding. A numerical score of 0, 1, or 2 is assigned to the five letters of the acronym: Latching of infant onto the breast, Amount of audible swallowing, Type of nipple, Comfort of mother, Help needed by mother to hold baby to breast. Lower scores (\< 5) can indicate the need for assistance for better success at breast-feeding.

  The first 24 hours of the postpartum period

Study Arms (3)

Group 1 (biological nurturing)

EXPERIMENTAL

In biological feeding, the mother takes a semi-sitting position and the baby lies face down on the mother's breast and belly, with every part of her body in contact with the mother.

Behavioral: Breastfeeding Education

Group 2 (classic breastfeeding)

EXPERIMENTAL

In classical breastfeeding, the mother holds her baby in her arms and breastfeeds while she is in a sitting position.

Behavioral: Breastfeeding Education

Group 3 (control)

NO INTERVENTION

The mother will breastfeed her baby as she wishes.

Interventions

Breastfeeding Education BEHAVIORAL

Biological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse.

Group 1 (biological nurturing); Group 2 (classic breastfeeding)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• GROUP 1:
• age range
• Nulliparous Pregnancy
• Single Pregnancy
• Gestational week 34- 36
• Those who are literate
• Those who have a smart phone and have the opportunity to benefit from teaching methods
• GROUP 2:
• age range
• Nulliparous Pregnancy
• Single Pregnancy
• Gestational week 34-36
• Those who are literate
• GROUP 3:
• age range

You may not qualify if:

• GROUP1:
• Presence of chronic disease
• Nipple problems
• Admission of the baby to the neonatal intensive care unit
• The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
• Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
• The presence of a disease in the mother that will prevent breastfeeding
• Pregnant women with vision and hearing problems
• GROUP 2:
• Presence of chronic disease
• Nipple problems
• Admission of the baby to the neonatal intensive care unit
• The presence of anomaly related to the baby (chromosomal anomaly, cleft palate/lip, tongue tie)
• Mothers in whom breastfeeding will be prohibited/suspected in the postpartum period
• The presence of a disease in the mother that will prevent breastfeeding

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

• Cohen SS, Alexander DD, Krebs NF, Young BE, Cabana MD, Erdmann P, Hays NP, Bezold CP, Levin-Sparenberg E, Turini M, Saavedra JM. Factors Associated with Breastfeeding Initiation and Continuation: A Meta-Analysis. J Pediatr. 2018 Dec;203:190-196.e21. doi: 10.1016/j.jpeds.2018.08.008. Epub 2018 Oct 4.

  PMID: 30293638 BACKGROUND

• Wang Y, Zhao T, Zhang Y, Li S, Cong X. Positive Effects of Kangaroo Mother Care on Long-Term Breastfeeding Rates, Growth, and Neurodevelopment in Preterm Infants. Breastfeed Med. 2021 Apr;16(4):282-291. doi: 10.1089/bfm.2020.0358. Epub 2021 Feb 2.

  PMID: 33533688 BACKGROUND

• Omidi A, Rahmani S, Amini R, Karami M. The effect of a planned lactation education program on the mother's breastfeeding practice and weight gain in low birth weight infants: a randomized clinical trial study. BMC Pregnancy Childbirth. 2022 Jun 13;22(1):482. doi: 10.1186/s12884-022-04810-z.

  PMID: 35698072 BACKGROUND

• von Salmuth V, Brennan E, Kerac M, McGrath M, Frison S, Lelijveld N. Maternal-focused interventions to improve infant growth and nutritional status in low-middle income countries: A systematic review of reviews. PLoS One. 2021 Aug 18;16(8):e0256188. doi: 10.1371/journal.pone.0256188. eCollection 2021.

  PMID: 34407128 BACKGROUND

• Huda MH, Chipojola R, Lin YM, Lee GT, Shyu ML, Kuo SY. The Influence of Breastfeeding Educational Interventions on Breast Engorgement and Exclusive Breastfeeding: A Systematic Review and Meta-Analysis. J Hum Lact. 2022 Feb;38(1):156-170. doi: 10.1177/08903344211029279. Epub 2021 Jul 6.

  PMID: 34229526 BACKGROUND

• Araban M, Karimian Z, Karimian Kakolaki Z, McQueen KA, Dennis CL. Randomized Controlled Trial of a Prenatal Breastfeeding Self-Efficacy Intervention in Primiparous Women in Iran. J Obstet Gynecol Neonatal Nurs. 2018 Mar;47(2):173-183. doi: 10.1016/j.jogn.2018.01.005. Epub 2018 Feb 3.

  PMID: 29406289 BACKGROUND

• Huang P, Yao J, Liu X, Luo B. Individualized intervention to improve rates of exclusive breastfeeding: A randomised controlled trial. Medicine (Baltimore). 2019 Nov;98(47):e17822. doi: 10.1097/MD.0000000000017822.

  PMID: 31764775 BACKGROUND

• Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD006425. doi: 10.1002/14651858.CD006425.pub4.

  PMID: 27922724 BACKGROUND

• Moraes GGW, Christoffel MM, Toso BRGO, Viera CS. Association between duration of exclusive breastfeeding and nursing mothers' self-efficacy for breastfeeding. Rev Esc Enferm USP. 2021 May 10;55:e03702. doi: 10.1590/S1980-220X2019038303702. eCollection 2021. English, Portuguese.

  PMID: 33978141 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: 30191591 BACKGROUND

• Sayres S, Visentin L. Breastfeeding: uncovering barriers and offering solutions. Curr Opin Pediatr. 2018 Aug;30(4):591-596. doi: 10.1097/MOP.0000000000000647.

  PMID: 29782384 BACKGROUND

• Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.

  PMID: 32248838 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: October 25, 2022
• Study Start: July 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)