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

NCT ID: NCT05796284

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-31

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.

Conditions

Breastfeeding; Pregnancy Related; Efficacy, Self

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Breast pressure relief intervention at the end of pregnancy

Intervention Type: BEHAVIORAL

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 .

Routine care

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: OTHER

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

Interventions

Breast 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 .

Intervention Type: BEHAVIORAL

Routine 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.

Intervention Type: OTHER

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

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

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

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Hsiang-Yun Lan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National defense medical center

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Lan Hsiang-Yun, A.P.

Role: CONTACT

shinnylan@msn.com

+886287923100 ext. 18781

Facility Contacts

Lan Hsiang-Yun, A.P.

Role: primary

shinnylan@msn.com

+886287923100 ext. 18781

Other Identifiers

C202205166

Identifier Type: -

Identifier Source: org_study_id