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

NCT05796284 | Recruiting

• 1 other identifier: C202205166
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Pregnancy Related; Efficacy, Self

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Breast pressure relief intervention at the end of pregnancy

EXPERIMENTAL

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; Other: Routine care

Routine care group

ACTIVE COMPARATOR

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

Interventions

Breast pressure relief intervention at the end of pregnancy 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 .

Breast pressure relief intervention at the end of pregnancy

Routine care 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.

Breast pressure relief intervention at the end of pregnancy; Routine care group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

National defense medical center

Taipei, 114201, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Lan Hsiang-Yun, A.P.

CONTACT

+886287923100; shinnylan@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 3, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TW (1)