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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06242886
Other study ID # Massage
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date September 20, 2023

Study information

Verified date January 2024
Source Halic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Mothers who had a cesarean delivery and were in the first 24 hours after birth were divided into three separate groups: breast massage, oxytocin massage and control group. Data Collection Form, LACTH, Infant Follow-up Form and Breastfeeding Self-Efficacy Scale were applied to all mothers included in the sampling in the postpartum period. 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. 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. Control group: Mothers were discontinued from routine care at the clinic.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 20, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Oxytocin massage
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.
and Breast 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.

Locations

Country Name City State
Turkey Fatma Sule Bilgiç Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding Self-Efficacy Breastfeeding Self-Efficacy Scale Total Score; Breastfeeding Charting System (LATCH) Turkish validity and reliability were made by Yenal and Okumus [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
Primary 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 Okumus [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
Primary Newborn Anthropometric Characteristics Weight Three times= immediately after birth, the first 24 hours after birth, and the 7th day after birth
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