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Completed

NCT Number: NCT06341140

The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Breastfeeding, Exclusive Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

İnclusion Criteria:

  • Open communication and collaboration
  • Over 18 years of age
  • Having a singleton pregnancy
  • Never given birth,
  • At least in the 35th week of gestation,
  • Residing in Manisa Central districts (Yunusemre and Şehzadeler),
  • There is no maternal obstacle that would affect breastfeeding,
  • Having no vision or hearing problems,
  • Those who are willing to participate in the study

Exclusion criteria

  • 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.

Treatment and study plan

Breastfeeding support and Booklet containing information about breastfeeding

Other

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.

Booklet containing information about breastfeeding

Other

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.

Primary outcomes

  1. Situation of mothers feeding their babies exclusively with breast milk

    Time frame: 6 months

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

  2. Mothers experiencing breast problems

    Time frame: 6 months

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

  3. Determination of mothers' breastfeeding self-efficacy

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

Does Individualized Breastfeeding Support Make a Difference in Exclusive Breastfeeding, Breast Problem Occurrence, and Breastfeeding Self-Efficacy in the First 6 Months: Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 2, 2024
Registry last updated
Apr 2, 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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