Breast Feeding, ExclusiveNCT06437093
The Effect of Relactation Support Program on Milk Release
A study testing TEACHING RELACTATION TECHNIQUES in people with Breast Feeding, Exclusive and Mother-Child Relations, run by Inonu University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive, Mother-Child Relations
- What is being tested?
- TEACHING RELACTATION TECHNIQUES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 22 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For mothers;
- Having no milk release,
- Using no pharmacological agents that may increase milk release,
- Being not pregnant,
- Having no communication problem,
- Being literate,
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- 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.)
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Feeding, Exclusive, Mother-Child Relations
- Being tested
- TEACHING RELACTATION TECHNIQUES
- Keywords
- breast feeding, connecting, maternal role
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACHING RELACTATION TECHNIQUESOther
Also called BREASTFEEDING EDUCATION
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: TEACHING RELACTATION TECHNIQUES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: First day
Secondary outcomes (3)
Questionnaire
Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.
Measured: 1-16 days
Scale 1 Scale 1 (Attachment Inventory)
Maternal Attachment Scale was used for posttest.
Measured: 16. day
Scale 2
The Barkin Index of Maternal Functioning was used for posttest.
Measured: 16. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Oct 2021
- Primary completion20 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group pre-test post-test experimental study.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel GÜÇLÜ CİHAN, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437093
- Sponsor's protocol ID
- emelabdullahyusuf46
- Status last verified
- May 2024
- First submitted
- 9 Jan 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relactation Support Program on Milk Release, Mother-Infant Attachment and Maternity Role
- ClinicalTrials.gov ID
- NCT06437093
- Acronym / sponsor ID
- emelabdullahyusuf46
- Conditions
- Breast Feeding, Exclusive, Mother-Child Relations
- Keywords
- breast feeding, connecting, maternal role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group pre-test post-test experimental study.
| Arm | Type | Receives |
|---|---|---|
| single-group pre-test post-test experimental study | Experimental | Other: TEACHING RELACTATION TECHNIQUESIn 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- For mothers;
- Having no milk release,
- Using no pharmacological agents that may increase milk release,
- Being not pregnant,
- Having no communication problem,
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACHING RELACTATION TECHNIQUESAlso: BREASTFEEDING EDUCATIONIn 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 | single-group pre-test post-test experimental study |
Primary outcome
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.
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.
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: * 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).
3 secondary outcomes
Questionnaire
Time frame: 1-16 days
Scale 1 Scale 1 (Attachment Inventory)
Time frame: 16. day
Scale 2
Time frame: 16. day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACHING RELACTATION TECHNIQUES in people with Breast Feeding, Exclusive and Mother-Child Relations, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: First day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.