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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 114201
- National Defense Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breast pressure relief intervention at the end of pregnancy
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.
|
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 .
Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.
|
|
Active Comparator: Routine care group
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.
|
Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
breast engorgement
Time Frame: Change from Baseline breast engorgement at 12 weeks after delivery.
|
the late pregnancy on the parturients' breast engorgement
|
Change from Baseline breast engorgement at 12 weeks after delivery.
|
|
The volume and speed of lactation
Time Frame: Change from Baseline lactation at 12 weeks after delivery.
|
the late pregnancy on the parturients' lactation
|
Change from Baseline lactation at 12 weeks after delivery.
|
|
Breastfeeding Self-efficacy Scale Short Form
Time Frame: Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
|
the late pregnancy on the parturients' breastfeeding
|
Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
|
|
Parental Self-efficacy Scale
Time Frame: Change from Baseline Parental self-efficacy at 12 weeks after delivery.
|
the late pregnancy on the parturients' maternal competence
|
Change from Baseline Parental self-efficacy at 12 weeks after delivery.
|
|
Perceived Stress Scale
Time Frame: Change from Baseline Perceived Stress Scale at 12 weeks after delivery.
|
late pregnancy on the parturients' stress
|
Change from Baseline Perceived Stress Scale at 12 weeks after delivery.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C202205166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.