Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement (ETBEG)

August 3, 2021 updated by: China Medical University Hospital

Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial

A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age > 37 wk
  • Delivery of singleton, healthy newborn baby
  • Within 7 days postpartum
  • Within 24 hours from initial painful breast engorgement
  • Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)

Exclusion Criteria:

  • Fever>37.5∘C
  • Mastitis or breast abscess
  • Signs of sepsis or other infection
  • Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
  • Psychological diseases
  • Bleeding tendency
  • Artificial valves
  • Pacemaker
  • Epilepsy
  • Consciousness disturbance
  • Skin infections
  • Hepatitis B carrier
  • Acquired Immune Deficiency Syndrome
  • Breast tumors
  • Breast Surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine care
Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.
Other: Routine care
Reverse pressure applied to the areola
Experimental: Routine care plus EA

Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.

plus: Electrical acupuncture on body acupoints
Other: Routine care
Reverse pressure applied to the areola
Procedure: Electrical Acupuncture
Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
Experimental: Routine care plus TENS

Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.

plus: Transcutaneous electrical nerve stimulation on breasts
Other: Routine care
Reverse pressure applied to the areola
Procedure: Transcutaneous Electrical Nerve Stimulation
Transcutaneous electrical nerve stimulation over bil breasts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity Index (0-19)
Time Frame: Changes from Baselines of Severity Index, at each treatment and 1 month later
Sum of the degree of Erythema, Tension and Pain scores over breasts
Changes from Baselines of Severity Index, at each treatment and 1 month later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPDS
Time Frame: Changes from Baseline of EPDS, after each treatment and 1 month later
Edinburgh Postnatal Depression Scale
Changes from Baseline of EPDS, after each treatment and 1 month later
BSES-SF
Time Frame: Changes from Baseline of BEES-SF, after each treatment and 1 month later
Breastfeeding Self-Efficacy Scale
Changes from Baseline of BEES-SF, after each treatment and 1 month later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRV
Time Frame: Change from Baseline of HRV, immediately after each treatment
Real-time handheld Heart-rate Variability
Change from Baseline of HRV, immediately after each treatment
Lab Data
Time Frame: Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment
Measurements of Oxytocin and Cortisol levels in breastmilk
Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Chair: Hung-Rong Yen, PhD, Department of Chinese Medicine, China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

October 8, 2017

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC1-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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