The Effect of Relactation Support Program on Milk Release

Mother-Child Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06437093
• Other study ID #: emelabdullahyusuf46
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 22, 2022

Study information

• Verified date: May 2024
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 22, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Mother-Child Relations

Intervention

Other:
• TEACHING RELACTATION TECHNIQUES
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.

Locations

Country	Name	City	State
Turkey	Inonu Universty	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	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
Primary	Scale 1	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
Primary	Scale 2	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	Questionnaire	Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.	1-16 days
Secondary	Scale 1 Scale 1 (Attachment Inventory)	Maternal Attachment Scale was used for posttest.	16. day
Secondary	Scale 2	The Barkin Index of Maternal Functioning was used for posttest.	16. day