The Effect of Relactation Support Program on Milk Release

Not Applicable

Completed

• Conditions: Breast Feeding, Exclusive; Mother-Child Relations

• Registration Number: NCT06437093
• Lead Sponsor: Inonu University

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-22
• Study First Submitted: 2024-01-09
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-25
• Last Update Submitted: 2024-05-25
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Scale 2	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).
Questionnaire	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.
Scale 1	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.

Secondary Outcome Measures

Name	Time	Method
Scale 1 Scale 1 (Attachment Inventory)	16. day	Maternal Attachment Scale was used for posttest.
Scale 2	16. day	The Barkin Index of Maternal Functioning was used for posttest.
Questionnaire	1-16 days	Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.

Trial Locations

Locations (1)

Inonu Universty; 🇹🇷 Malatya, Turkey