- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437093
The Effect of Relactation Support Program on Milk Release
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey
- İnonü Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- emelabdullahyusuf46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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