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Completed

NCT Number: NCT06437093

The Effect of Relactation Support Program on Milk Release

Aim: This study aimed to determine the effect of relactation support program on milk release, mother-infant attachment and maternity role.

Materials and Methods: This single-group pre-test post-test experimental study was conducted with 34 mothers who had 1-4 month old infants, stopped breastfeeding at least 15 days and at most 3 months ago and were registered in the family health centers of a province in the southern Turkey. The relactation support program was completed in 15 days, with eight home visits and seven telephone support sessions. The data were collected using a personal information form, a mother-infant follow-up form, the Maternal Attachment Inventory (MAI) and the Barkin Index of Maternal Functioning (BIMF).

Keywords: Mother-Infant Attachment, Maternity Role, Midwifery, Relactation, Milk Release.

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Key information

Conditions

Breast Feeding, Exclusive Behavior Breast Feeding Feeding Behavior Mother-Child Relations

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu Universty

Malatya, Turkey (Türkiye)

About this study

This is a single-group pre-test post-test experimental study. This study was conducted between October 2021 and October 2022 in Family Health Centers (FHCs) in province in southern Turkey. By using the G*power 3.1 program, the sample size was determined to include 29 mothers/women under 5% margin of error, 95% confidence level, and 95% power of representation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For mothers;

  • Having no milk release,
  • Using no pharmacological agents that may increase milk release,
  • Being not pregnant,
  • Having no communication problem,
  • Being literate,
  • Being between the ages of 18-35 years,
  • Having singleton gestation in their last childbirth,
  • Using no medication that prevents breastfeeding (chemotherapy, etc.). For babies;
  • Being healthy
  • Having no congenital sucking problem (cleft palate, cleft lip, etc.)

Exclusion criteria

For mothers;

  • Using any pharmacologic agent to increase milk release,
  • Having a diagnosis of psychiatric illness. For babies;
  • Having any metabolic disease that may prevent breastfeeding (galactosemia, phenylketonuria, etc.) or any other chronic disease (advanced heart disease, etc.).

Treatment and study plan

TEACHING RELACTATION TECHNIQUES

Other

In our midwifery intervention, the mother was firstly educated about breastfeeding and relactation, using educational brochures prepared by the researchers. Afterwards, the mother was taught "nipple stimulation", "skin-to-skin contact" and "finger feeding method", and the first feeding of the baby was performed together with the mother. After this first intervention in the FHC, all interventions were performed at home. The follow-ups continued for 15 days with one day of telephone support and one day of home visit. Since the majority of mothers did not accept video calls (privacy, etc.), telephone support was provided only verbally.

Other names: BREASTFEEDING EDUCATION

Primary outcomes

  1. Questionnaire

    Time frame: First day

    Mother-Infant Follow-Up Form filled out at the first meeting with the participants.This form was prepared by the researchers and includes information about the mothers' breastfeeding issues, breast health problems (cracks, mastitis, etc.), number of daily breastfeeding, number of daily milk release, amount of milk release, baby's weight and presence of sucking problems, which should be followed up during relactation.

  2. Scale 1

    Time frame: First day

    Maternal Attachment Scale was used for pretest.This 4-point Likert-type scale has a total of 26 items, scoring as "always =4", "often =3", "sometimes =2", and "never =1". The lowest and highest scores on the scale are 26 and 104, respectively. Higher scale scores refer to greater maternal attachment.

  3. Scale 2

    Time frame: First day

    Barkin Index of Maternal Functioning Scale was used for pretest. Index of Maternal Functioning consists of 16 items, scoring as "completely disagree=0", "disagree=1", "partially disagree=2", "undecided=3", "partially agree=4", "agree=5", "completely agree=6". The lowest and highest scores on the scale are 0 and 96, respectively. The scale has five subscales:

    • Self-Care (2, 11, 13 items)
    • Maternal Psychology (8, 10 items)
    • Infant Care (items 12, 14, 15, 16)
    • Social Support (items 6, 7, 9)
    • Maternal adjustment (items 1, 3, 4, 5).

Secondary outcomes

  1. Questionnaire

    Time frame: 1-16 days

    Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.

  2. Scale 1 Scale 1 (Attachment Inventory)

    Time frame: 16. day

    Maternal Attachment Scale was used for posttest.

  3. Scale 2

    Time frame: 16. day

    The Barkin Index of Maternal Functioning was used for posttest.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effect of Relactation Support Program on Milk Release, Mother-Infant Attachment and Maternity Role

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 31, 2024
Registry last updated
May 31, 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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