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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05796284
Enrollment
160
Registered
2023-04-03
Start date
2023-08-01
Completion date
2024-07-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Efficacy, Self, Pregnancy Related

Keywords

breast tenderness relief intervention, breast engorgement, breastfeeding, maternal efficacy

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.

Interventions

BEHAVIORALBreast pressure relief intervention at the end of pregnancy

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 .

OTHERRoutine care

Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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

1. Pregnant women with a history of smoking, alcohol, and drug abuse; 2. Pregnant women have mental illness; 3. Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.; 4. Newborns with congenital abnormalities and major diseases; 5. Pregnant women who are unable or unwilling to breastfeed due to illness or other factors; 6. Refuse to accept breast compression intervention will be excluded from participating in the study

Design outcomes

Primary

MeasureTime frameDescription
breast engorgementChange from Baseline breast engorgement at 12 weeks after delivery.the late pregnancy on the parturients' breast engorgement
The volume and speed of lactationChange from Baseline lactation at 12 weeks after delivery.the late pregnancy on the parturients' lactation
Breastfeeding Self-efficacy Scale Short FormChange from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.the late pregnancy on the parturients' breastfeeding
Parental Self-efficacy ScaleChange from Baseline Parental self-efficacy at 12 weeks after delivery.the late pregnancy on the parturients' maternal competence
Perceived Stress ScaleChange from Baseline Perceived Stress Scale at 12 weeks after delivery.late pregnancy on the parturients' stress

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026