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Clinical Trials/NCT05593536
NCT05593536CompletedNot Applicable

Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

Istanbul University - Cerrahpasa (IUC)1 site in 1 country207 target enrollmentStarted: July 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
207
Locations
1
Primary Endpoint
Higher ''LATCH Scale'' score in the biological nurturing group

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18-35 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
  • 18-35 age range
  • Nulliparous Pregnancy
  • Single Pregnancy
  • Gestational week 34-36
  • Those who are literate
  • 18-35 age range
  • Nulliparous Pregnancy
  • Single Pregnancy
  • Gestational week 34-36 gw
  • Those who are literate

Exclusion Criteria

  • 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
  • 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
  • Pregnant women who go to pregnancy school
  • 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

Outcomes

Primary Outcomes

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

Time Frame: The first 24 hours of the postpartum period

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.

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

Time Frame: The first 24 hours of the postpartum period

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Dogan

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Study Sites (1)

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