## Protocol Section
### Identification Module
**NCT ID:** NCT06437093

**Brief Title:** The Effect of Relactation Support Program on Milk Release

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

#### Organization Study ID Info
**ID:** emelabdullahyusuf46
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2022-10-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-10-20

**Type:** ACTUAL

#### Start Date
**Date:** 2021-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-01-09
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Inonu University

#### Responsible Party

**Investigator Affiliation:** Inonu University

**Investigator Full Name:** Emel GÜÇLÜ CİHAN

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Breast Feeding, Exclusive

- Mother-Child Relations

**Keywords:**

- breast feeding

- connecting

- maternal role

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This is a single-group pre-test post-test experimental study.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: TEACHING RELACTATION TECHNIQUES

**Label:** single-group pre-test post-test experimental study

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- single-group pre-test post-test experimental study

**Description:** 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.

**Name:** TEACHING RELACTATION TECHNIQUES

**Other Names:**

- BREASTFEEDING EDUCATION

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Questionnaire

**Time Frame:** First day

**Description:** 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.

**Measure:** Scale 1

**Time Frame:** First day

**Description:** 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).

**Measure:** Scale 2

**Time Frame:** First day

#### Secondary Outcomes

**Description:** Mother-Infant Follow-Up Form was filled out every day for 15 days.Finally, it was filled on the 16th day.

**Measure:** Questionnaire

**Time Frame:** 1-16 days

**Description:** Maternal Attachment Scale was used for posttest.

**Measure:** Scale 1 Scale 1 (Attachment Inventory)

**Time Frame:** 16. day

**Description:** The Barkin Index of Maternal Functioning was used for posttest.

**Measure:** Scale 2

**Time Frame:** 16. day

### Eligibility Module

**Eligibility Criteria:** 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.).

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Malatya

**Country:** Turkey

**Facility:** Inonu Universty

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
