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

Sponsor
National Defense Medical Center, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05796284
Collaborator
(none)
180
1
2
24
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Breast pressure relief intervention at the end of pregnancy
  • Other: Routine care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effects of Breast Tenderness Relief Intervention During the Late Pregnancy on the Parturients' Breast Engorgement, Lactation, Breastfeeding, Maternal Competence, and Stress
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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.

Behavioral: 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 .

Other: 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.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. breast engorgement [Change from Baseline breast engorgement at 12 weeks after delivery.]

    the late pregnancy on the parturients' breast engorgement

  2. The volume and speed of lactation [Change from Baseline lactation at 12 weeks after delivery.]

    the late pregnancy on the parturients' lactation

  3. Breastfeeding Self-efficacy Scale Short Form [Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.]

    the late pregnancy on the parturients' breastfeeding

  4. Parental Self-efficacy Scale [Change from Baseline Parental self-efficacy at 12 weeks after delivery.]

    the late pregnancy on the parturients' maternal competence

  5. Perceived Stress Scale [Change from Baseline Perceived Stress Scale at 12 weeks after delivery.]

    late pregnancy on the parturients' stress

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National defense medical center Taipei Taiwan 114201

Sponsors and Collaborators

  • National Defense Medical Center, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hsiang-Yun Lan, Associate Professor, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier:
NCT05796284
Other Study ID Numbers:
  • C202205166
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hsiang-Yun Lan, Associate Professor, National Defense Medical Center, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023