Effect of Biological Nurturing Education to Pregnant Women on Breastfeeding Status

October 16, 2024 updated by: Elif Dogan, Istanbul University - Cerrahpasa (IUC)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul University Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Two weeks after the first training
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.
The first 24 hours of the postpartum period
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.
The first 24 hours of the postpartum period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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