Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

NCT ID: NCT05401123

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2022-07-15

Brief Summary

The researchers planned this study to compare the effects of breast pumps, which are frequently used today, and manual milking after manual massage on the change in milk content when breast and breastfeeding problems develop.

Detailed Description

Comparison of the methods used to solve the milk secretion and breastfeeding problems of the participants in the postpartum period; effective and uncomplicated methods should be put forward. Today, breast milk is expressed by hand using massage or pumps. Both milking techniques used have positive and negative aspects. While there are studies showing that breast milk content is affected by the milking techniques used, there are also studies showing that it does not. This study by the researchers was planned to compare the effects of post-massage pumps and manual milking on the change in milk content. For this reason, it is thought that the researchers will contribute to the literature scientifically and, since it is a doctoral thesis, it can be a guide for future studies on the subject.

Conditions

Breastfeeding; Human Milk

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Comparison of Breast Milk Content in Mothers Using a Expressing Pump and Milking by Hand

Randomization In order to ensure similarity between groups; Stratified block randomization was used to assign the women in the sample group to the experimental and control groups. According to the stratified block randomization method, the imbalances that may occur in the experimental and control groups are limited. In this method, block randomization is performed within each stratum after stratification according to risk factors (Akın & Koçoğlu, 2017; Kanık, Taşdelen & Erdoğan, 2011). Since the mode of delivery affects the content of breast milk, women will be divided into two layers as vaginal delivery and cesarean section in terms of delivery type (Table 1).

In order to determine the strata group of the woman who was found to meet the research criteria and accepted to participate in the study, a list of assignments was created through the website www.randomizer.org by making 6 blocks with a combination of 4 .

Experiment: A Control: B

Group Type: EXPERIMENTAL

milking pump

Intervention Type: DEVICE

n the study, all mothers who come to the Lactation/Relactation outpatient clinic will be informed about the study, and mothers who accept the study will have to fill out the "Conformity to Criteria Form" created by the researcher. Between the ages of 20-35, postpartum 1-5. Participants who gave birth after the 37th week of pregnancy, did not have literacy problems, mental disabilities and communication problems, did not have chronic diseases, did not use any medication, and volunteered to participate in the study will be included in the study. by milking, 2 ml of first milk will be taken from the participants in the control group (via the milking pump). The collected milk will be taken to the laboratory for analysis by the researcher.

Interventions

milking pump

n the study, all mothers who come to the Lactation/Relactation outpatient clinic will be informed about the study, and mothers who accept the study will have to fill out the "Conformity to Criteria Form" created by the researcher. Between the ages of 20-35, postpartum 1-5. Participants who gave birth after the 37th week of pregnancy, did not have literacy problems, mental disabilities and communication problems, did not have chronic diseases, did not use any medication, and volunteered to participate in the study will be included in the study. by milking, 2 ml of first milk will be taken from the participants in the control group (via the milking pump). The collected milk will be taken to the laboratory for analysis by the researcher.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Between the ages of 20-35

• Postpartum 1-5. between the day
• Those who gave birth after the 37th week of pregnancy
• The baby does not have any condition that prevents sucking
• Those whose baby is not hospitalized in the neonatal intensive care unit
• Those who do not have literacy problems, mental disabilities and communication problems
• Mothers who agreed to participate in the study voluntarily

Exclusion Criteria

Those who want to quit working voluntarily

• Inaccessible, cut off communication during operation
• Mothers whose babies were hospitalized during the study
• Hospitalized during the study
• Not completing study post-tests
• Who does not do any milking for a day
• Mothers who express only once a day for two consecutive days

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Şengül Yaman Sözbir

associate oroffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

mineis001

Identifier Type: -

Identifier Source: org_study_id