NCT06341140

Brief Summary

The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

February 29, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Situation of mothers feeding their babies exclusively with breast milk

    Determination of mothers' status of exclusively breastfeeding their babies for the first 6 months using a survey form created by researchers.

    6 months

  • Mothers experiencing breast problems

    Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.

    6 months

  • Determination of mothers' breastfeeding self-efficacy

    Breastfeeding competencies were assessed with the LATCH breastfeeding diagnostic tool and the breastfeeding self-efficacy scale. Mothers' breastfeeding success was examined with the LATCH breastfeeding diagnostic tool. On this scale, they can get a minimum of 0 and a maximum of 10 points. As the score increases, breastfeeding success increases. The breastfeeding self-efficacy scale determines the self-efficacy of mothers and can get a minimum of 33 and a maximum of 165 points. As the average score increases, breastfeeding self-efficacy is expressed as high.

    6 months

Study Arms (2)

control

EXPERIMENTAL

Pregnant women in the control group were given a booklet containing information about breastfeeding. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months.

Other: Booklet containing information about breastfeeding

intervention

EXPERIMENTAL

Pregnant women in the intervention group were given a booklet containing information about breastfeeding. At the same time, individual breastfeeding support was provided with a wearable breastfeeding model. In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months.

Other: Breastfeeding support and Booklet containing information about breastfeeding

Interventions

Pregnant women in the intervention group were given individual counseling with a wearable breastfeeding model. During postnatal home visits, mothers were given support on breastfeeding, breast problems were addressed, and information was given to support the mother's self-efficacy.

intervention

Pregnant women in the control group were given only a breastfeeding booklet, breastfeeding status, breast problems and breastfeeding self-efficacy were evaluated during postnatal home visits and telephone interviews, and risky situations were referred to health professionals.

control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • At the beginning of the research;
  • Under 18 years of age,
  • Having a risky pregnancy,
  • Having breastfeeding experience,
  • Less than the 35th gestational week,
  • Residing outside Manisa Central districts (Yunusemre and Şehzadeler),
  • Any maternal disability that may affect breastfeeding,
  • Pregnant women who did not want to participate in the study were excluded.
  • During the research process;
  • Those who want to leave the job,
  • If the baby has any obstacle that may affect breastfeeding (presence of anomaly, stay in intensive care, etc.),
  • Cannot be reached within the first 5 days after birth,
  • Mothers who changed their residence to live in another city/district other than Manisa Central districts (Yunusemre and Şehzadeler) were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Seval Cambaz Ulaş

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 29, 2024

First Posted

April 2, 2024

Study Start

August 1, 2021

Primary Completion

November 30, 2022

Study Completion

February 6, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations