NCT06242886

Brief Summary

Background: Delays in breastfeeding and milk release after cesarean section may negatively affect the early initiation of breastfeeding and the mother's breastfeeding self-efficacy. Research Aims: The aim of this study was to investigate the effect of breast and oxytocin massage after cesarean section on the anthropometric characteristics of the newborn and breastfeeding self-efficacy. Methods: The study was conducted in a single-blind randomized controlled type and 126 mothers who delivered by cesarean section in the postpartum department of a private hospital in Istanbul/Turkey were randomized into three groups as 42 breast massage, 42 oxytocin massage and 42 control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

February 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 12, 2024

Last Update Submit

January 29, 2024

Conditions

Keywords

Breastfeeding self-efficacyC-section,oxytocin

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Self-Efficacy

    Breastfeeding Self-Efficacy Scale Total Score; Breastfeeding Charting System (LATCH) Turkish validity and reliability were made by Yenal and Okumuş \[12\]. Scale was developed to evaluate the breastfeeding. On the LATCH scale, a score of 0, 1 or 2 is given for each criterion. A minimum of 0-Maximum score of 10 points is taken from the scale. A low score by the mother indicates that she needs help with breastfeeding. Scoring is done by observing breastfeeding.

    Three times=immediately after birth, the first 24 hours after birth, and the 7th day after birth

  • Breastfeeding success

    Breastfeeding success (LATCH) total score; As the LATCH score increases, it is understood that breastfeeding success is high. LATCH Cronbach's Alpha value: It was found to be 0.95 by Yenal and Okumuş \[12\]. In this study, 0.86 found. Developed to evaluate the breastfeeding self-efficacy levels of mothers. The Breastfeeding Self-Efficacy Short Form Scale is a Likert-type scale with 5 points. The minimum score that can be taken from the scale is 14 and the maximum score is 70. The higher the score, the higher the breastfeeding shows self-efficacy. The Turkish validity and reliability study of the scale was conducted by Tokat et al.\[13\] and Cronbach's Alpha value was found to be 0.86

    Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth

  • Newborn Anthropometric Characteristics

    Weight

    Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth

Study Arms (3)

Oxytocin massage

EXPERIMENTAL

The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours.

Behavioral: Oxytocin massage

Breast massage

EXPERIMENTAL

The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours.

Behavioral: and Breast massage

Control

NO INTERVENTION

No intervention

Interventions

Oxytocin massage group: The mother was positioned on a chair with her breasts bare and free, placing her arms on the table at her height and her head on her arms. The researcher who applied the massage applied the massage up and down to either side of the spine between the mother's scapula bones with her thumbs in front and pressing her fists tightly and making small circular movements with her thumbs for three minutes. The mothers received four oxytocin massages over the course of 24 hours.

Oxytocin massage

Breast massage group: The mother's upper clothes were removed by the researcher. With the palms of the hand the breast grasped from the bottom and top. The hands were advanced by pressing slowly from the base of the nipple towards the nipple. With the palms, the breast was grasped from the bottom and top and gently pressed. Using fingertips, the breast was scanned by massaging from the base of the nipple to the nipple in circular movements. The mothers received breast massage four times over the course of 24 hours.

Breast massage

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum, primiparous woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study included mothers between the ages of 18 and 35, who were primiparous, due (37-42 GW) and cesarean section, who could understand and speak Turkish, who had no anatomical problems with their breasts, and who were in the first 24 hours after birth.

You may not qualify if:

  • Mothers with communication problems, having a chronic illness, breastfeeding related problems (breast or newborn) and mothers with newborns with IUGR or genetic disease were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Şule Bilgiç

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The mothers included in the study were blind to each other in terms of application, and the researcher who collected the data was blind to the groups in the study in terms of analysis and reporting. Breast and oxytocin massage and follow-up were carried out by the researcher (FŞB), who could not be blind to the applications. Randomization was done by another researcher (AYK). To avoid bias, the researcher who commissioned the study (FŞB) was not involved in any step of the data collection and statistical evaluation process
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A Single Blind, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 5, 2024

Study Start

February 20, 2023

Primary Completion

August 20, 2023

Study Completion

September 20, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01

Locations