search
Back to results

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

Primary Purpose

Breast Engorgement in Puerperium, Post Partum Depression

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Routine care
Electrical Acupuncture
Transcutaneous Electrical Nerve Stimulation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Engorgement in Puerperium focused on measuring Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Routine care

Routine care plus EA

Routine care plus TENS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Severity Index (0-19)
Sum of the degree of Erythema, Tension and Pain scores over breasts

Secondary Outcome Measures

EPDS
Edinburgh Postnatal Depression Scale
BSES-SF
Breastfeeding Self-Efficacy Scale

Full Information

First Posted
October 8, 2017
Last Updated
August 3, 2021
Sponsor
China Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04998565
Brief Title
Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement
Acronym
ETBEG
Official Title
Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Engorgement in Puerperium, Post Partum Depression
Keywords
Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine care
Arm Type
Experimental
Arm Description
Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.
Arm Title
Routine care plus EA
Arm Type
Experimental
Arm Description
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
Arm Title
Routine care plus TENS
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Reverse pressure applied to the areola
Intervention Type
Procedure
Intervention Name(s)
Electrical Acupuncture
Intervention Description
Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
Transcutaneous electrical nerve stimulation over bil breasts
Primary Outcome Measure Information:
Title
Severity Index (0-19)
Description
Sum of the degree of Erythema, Tension and Pain scores over breasts
Time Frame
Changes from Baselines of Severity Index, at each treatment and 1 month later
Secondary Outcome Measure Information:
Title
EPDS
Description
Edinburgh Postnatal Depression Scale
Time Frame
Changes from Baseline of EPDS, after each treatment and 1 month later
Title
BSES-SF
Description
Breastfeeding Self-Efficacy Scale
Time Frame
Changes from Baseline of BEES-SF, after each treatment and 1 month later
Other Pre-specified Outcome Measures:
Title
HRV
Description
Real-time handheld Heart-rate Variability
Time Frame
Change from Baseline of HRV, immediately after each treatment
Title
Lab Data
Description
Measurements of Oxytocin and Cortisol levels in breastmilk
Time Frame
Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, PhD
Organizational Affiliation
Department of Chinese Medicine, China Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs