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Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05593536
Collaborator
(none)
207
Enrollment
1
Location
3
Arms
3.9
Anticipated Duration (Months)
52.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Breastfeeding Education
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
207 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 (biological nurturing)

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
Biological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse.
Experimental: Group 2 (classic breastfeeding)

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

Behavioral: Breastfeeding Education
Biological feeding and classical breastfeeding trainings will be given to pregnant women by a trained nurse.
No Intervention: Group 3 (control)

The mother will breastfeed her baby as she wishes.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Cerrahpasa Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elif Dogan, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05593536
Other Study ID Numbers:
  • 2022/84
First Posted:
Oct 25, 2022
Last Update Posted:
Oct 25, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Dogan, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
biological nurturing
breastfeeding
education

Study Results

No Results Posted as of Oct 25, 2022