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Completed

NCT Number: NCT05593536

Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

GROUP 1:

  • 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

GROUP 2:

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

GROUP 3:

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

Exclusion criteria

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
  • Pregnant women with vision and hearing problems

GROUP 3:

  • 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

Treatment and study plan

Breastfeeding Education

Behavioral

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

Primary outcomes

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

    Time frame: Two weeks after the first training

    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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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