NCT05433818

Brief Summary

Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment. Design: This study was planned as a three-group randomized controlled study. Setting and participants: This study will conduct with 92 women in a delivery room in Turkey between October 2021 and May 2022. Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A), breastfeeding education (Group B), and control groups (Group C). Group A received SSC education and Group B received structured breastfeeding education.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
Last Updated

February 16, 2023

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 13, 2022

Last Update Submit

February 14, 2023

Conditions

BreastfeedingPostpartumInfant Development

Keywords

Breastfeeding educationBreastfeeding efficiencyInfantMaternal attachmentSkin-to-skin contact

Outcome Measures

Primary Outcomes (2)

  • Skin-to-skin contact

    Positive effect of skin-to-skin contact on maternal attachment and breastfeeding efficiency

    6-8 hours

  • Breastfeeding education

    positive effect of providing education with a structured and expert opinion-based breastfeeding brochure on maternal attachment and breastfeeding efficiency

    6-8 hours

Study Arms (3)

Skin-to-skin care

EXPERIMENTAL

Pregnant women will assigned to SSC were inform about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A also benefit from the hospital's routine breastfeeding education service. As a result, after the SSC application, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale.

Behavioral: Group A

Breastfeeding Education

ACTIVE COMPARATOR

Group B will received face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered. As a result, after the breastfeeding education, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale.

Other: Group B

Kontrol

NO INTERVENTION

No intervention will made to Group C by the researchers. Participants will benefit from the hospital's routine care and breastfeeding education services. As a result, postpartum mother will be evaluated with breastfeeding efficiency scale and maternal attachment scale.

Interventions

Group ABEHAVIORAL

Skin-to-Skin Contact (SSC) contributes to mother-infant interaction and can increase breastfeeding success

Also known as: Skin-to-skin Contact
Skin-to-skin care
Group BOTHER

education with a structured and expert opinion-based breastfeeding brochure

Also known as: Breastfeeding education
Breastfeeding Education

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostpartum women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • were having a primiparous pregnancy,
  • being open to cooperation,
  • having a vaginal delivery,
  • giving a single mature birth,
  • having no communication problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 27, 2022

Study Start

January 15, 2022

Primary Completion

April 15, 2022

Study Completion

May 15, 2022

Last Updated

February 16, 2023

Record last verified: 2022-06

Locations

TU(1)