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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06437093
Other study ID # emelabdullahyusuf46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.).

Study Design


Related Conditions & MeSH terms


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
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