NCT06437093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

January 9, 2024

Last Update Submit

May 25, 2024

Conditions

Keywords

breast feedingconnectingmaternal role

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Questionnaire

    1-16 days

  • Scale 1 Scale 1 (Attachment Inventory)

    16. day

  • Scale 2

    16. day

Study Arms (1)

single-group pre-test post-test experimental study

EXPERIMENTAL

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: TEACHING RELACTATION TECHNIQUES

Interventions

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.

Also known as: BREASTFEEDING EDUCATION
single-group pre-test post-test experimental study

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Universty

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single-group pre-test post-test experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2024

First Posted

May 31, 2024

Study Start

October 1, 2021

Primary Completion

October 20, 2022

Study Completion

October 22, 2022

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations