The Effect of Relactation Support Program on Milk Release

May 25, 2024 updated by: Emel GÜÇLÜ CİHAN, Inonu University

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • 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

      • Malatya, Turkey
        • İnonü Universty

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-group pre-test post-test experimental study
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First day
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.
First day
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).
First day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-16 days
Scale 1 Scale 1 (Attachment Inventory)
Time Frame: 16. day
Maternal Attachment Scale was used for posttest.
16. day
Scale 2
Time Frame: 16. day
The Barkin Index of Maternal Functioning was used for posttest.
16. day

Collaborators and Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 22, 2022

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

May 25, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • emelabdullahyusuf46

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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