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Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress

Primary Purpose

Pregnant Woman, Breastfeeding, Maternal Competence

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Breast pressure relief intervention at the end of pregnancy
Routine care
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnant Woman focused on measuring breast tenderness relief intervention, breast engorgement, breastfeeding, maternal competence, stress

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1. Healthy pregnant women over 20 years old, without mental illness, and the number of pregnancy weeks has reached 36 weeks; 2. Full term production; 3. Literate or able to communicate in Chinese and Taiwanese; 4. After explaining, agree to participate in the research, sign the consent form, and accept long-term follower Exclusion Criteria: Pregnant women with a history of smoking, alcohol, and drug abuse; Pregnant women have mental illness; Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.; Newborns with congenital abnormalities and major diseases; Pregnant women who are unable or unwilling to breastfeed due to illness or other factors; Refuse to accept breast compression intervention will be excluded from participating in the study

Sites / Locations

  • National defense medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breast pressure relief intervention at the end of pregnancy

Routine care group

Arm Description

The "Breast Compression Intervention at the End of Pregnancy" group is expected to start after the 36th week of pregnancy and continue until three months after delivery. In addition to routine care, breast relaxation methods of different intensities during pregnancy and postpartum will be provided in stages.

Cases in the routine care group receive routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery, including breastfeeding posture and skills, hand expression, and breast milk storage methods, etc.

Outcomes

Primary Outcome Measures

breast engorgement
the late pregnancy on the parturients' breast engorgement
The volume and speed of lactation
the late pregnancy on the parturients' lactation
Breastfeeding Self-efficacy Scale Short Form
the late pregnancy on the parturients' breastfeeding
Parental Self-efficacy Scale
the late pregnancy on the parturients' maternal competence
Perceived Stress Scale
late pregnancy on the parturients' stress

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
March 21, 2023
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05796284
Brief Title
Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress
Official Title
Effects of Breast Tenderness Relief Intervention During the Late Pregnancy on the Parturients' Breast Engorgement, Lactation, Breastfeeding, Maternal Competence, and Stress
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study purpose is to examine the effects of breast tenderness relief intervention during the late pregnancy on the parturients' breast engorgement, lactation, breastfeeding, maternal competence, and stress.
Detailed Description
Background: Maternal and child health is an important global health issue. Breast milk is the best food for infants and has many benefits for both mothers and infants. However, the breastfeeding rate in Taiwan has not increased but decreased in recent years. Breast engorgement and hypogalactia often cause distress for many women, and lead to stress and abandonment of breastfeeding, which in turn affects the achievement of motherhood. Therefore, nurses should provide support interventions for parturients early. Methods: This study is a two-years, prospective randomized controlled trial, and will adopt a longitudinal repeated-measures design. Convenience sampling will be used to recruit 180 pregnancy and postpartum women in the obstetrics clinic and postpartum ward of a medical center. The participants will be randomly assigned into two conditions (routine care and the breast tenderness relief intervention condition). The intervention will be provided to the participants from the 36th week of pregnancy until three months after delivery. Questionnaires, and biological measurements will be used to collect data. The outcome variables include the degree of breast engorgement, lactation, breastfeeding, maternal competencies, and stress. In addition, those data will be collected at the 36th and 38th week of pregnancy, three days, six weeks, and twelve weeks after childbirth. It is expected to analyze the research results with generalized estimation equation method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Woman, Breastfeeding, Maternal Competence
Keywords
breast tenderness relief intervention, breast engorgement, breastfeeding, maternal competence, stress

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast pressure relief intervention at the end of pregnancy
Arm Type
Experimental
Arm Description
The "Breast Compression Intervention at the End of Pregnancy" group is expected to start after the 36th week of pregnancy and continue until three months after delivery. In addition to routine care, breast relaxation methods of different intensities during pregnancy and postpartum will be provided in stages.
Arm Title
Routine care group
Arm Type
Active Comparator
Arm Description
Cases in the routine care group receive routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery, including breastfeeding posture and skills, hand expression, and breast milk storage methods, etc.
Intervention Type
Behavioral
Intervention Name(s)
Breast pressure relief intervention at the end of pregnancy
Intervention Description
When teaching pregnant women, the researchers will use tablet computers and models to explain the operation of breast combing and acupressure one-on-one, and use the model to demonstrate. Emphasis on breast grooming during pregnancy, twice a day, once in the morning and evening, 5 minutes on one breast each time, 10 minutes on both sides; strengthen breast grooming and acupressure after delivery. The first breast combing, 5 minutes on one breast each time, and 10 minutes on both sides 4 to 6 times a day. After combing, according to expert advice, massage the 6 acupoints around the breast for 5-10 seconds, and then use hand expressing or breastfeeding to discharge the milk .
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.
Primary Outcome Measure Information:
Title
breast engorgement
Description
the late pregnancy on the parturients' breast engorgement
Time Frame
Change from Baseline breast engorgement at 12 weeks after delivery.
Title
The volume and speed of lactation
Description
the late pregnancy on the parturients' lactation
Time Frame
Change from Baseline lactation at 12 weeks after delivery.
Title
Breastfeeding Self-efficacy Scale Short Form
Description
the late pregnancy on the parturients' breastfeeding
Time Frame
Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
Title
Parental Self-efficacy Scale
Description
the late pregnancy on the parturients' maternal competence
Time Frame
Change from Baseline Parental self-efficacy at 12 weeks after delivery.
Title
Perceived Stress Scale
Description
late pregnancy on the parturients' stress
Time Frame
Change from Baseline Perceived Stress Scale at 12 weeks after delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Healthy pregnant women over 20 years old, without mental illness, and the number of pregnancy weeks has reached 36 weeks; 2. Full term production; 3. Literate or able to communicate in Chinese and Taiwanese; 4. After explaining, agree to participate in the research, sign the consent form, and accept long-term follower Exclusion Criteria: Pregnant women with a history of smoking, alcohol, and drug abuse; Pregnant women have mental illness; Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.; Newborns with congenital abnormalities and major diseases; Pregnant women who are unable or unwilling to breastfeed due to illness or other factors; Refuse to accept breast compression intervention will be excluded from participating in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Hsiang-Yun, A.P.
Phone
+886287923100
Ext
18781
Email
shinnylan@msn.com
Facility Information:
Facility Name
National defense medical center
City
Taipei
ZIP/Postal Code
114201
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Hsiang-Yun, A.P.
Phone
+886287923100
Ext
18781
Email
shinnylan@msn.com

12. IPD Sharing Statement

Learn more about this trial

Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress

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