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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Breast Tenderness Relief Intervention During the Late Pregnancy on the Parturients' Breast Engorgement, Lactation, Breastfeeding, Maternal Competence, and Stress

Conditions
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Pregnant Woman, Breastfeeding, Maternal Competence

Intervention / Treatment
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* Behavioral: Breast pressure relief intervention at the end of pregnancy
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast pressure relief intervention at the end of pregnancy<br>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. | Behavioral: Breast pressure relief intervention at the end of pregnancy<br>* 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 .<br>Other: Routine care<br>* Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.<br>|
| Active Comparator: Routine care group<br>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. | Other: Routine care<br>* Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast engorgement | the late pregnancy on the parturients' breast engorgement | Change from Baseline breast engorgement at 12 weeks after delivery. | 
| The volume and speed of lactation | the late pregnancy on the parturients' lactation | Change from Baseline lactation at 12 weeks after delivery. | 
| Breastfeeding Self-efficacy Scale Short Form | the late pregnancy on the parturients' breastfeeding | Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery. | 
| Parental Self-efficacy Scale | the late pregnancy on the parturients' maternal competence | Change from Baseline Parental self-efficacy at 12 weeks after delivery. | 
| Perceived Stress Scale | late pregnancy on the parturients' stress | Change from Baseline Perceived Stress Scale at 12 weeks after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast tenderness relief intervention, breast engorgement, breastfeeding, maternal competence, stress