NCT04998565

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

October 8, 2017

Last Update Submit

August 3, 2021

Conditions

Breast Engorgement in PuerperiumPost Partum Depression

Keywords

Electrical acupunctureTranscutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

  • Severity Index (0-19)

    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 Outcomes (2)

  • EPDS

    Changes from Baseline of EPDS, after each treatment and 1 month later

  • BSES-SF

    Changes from Baseline of BEES-SF, after each treatment and 1 month later

Other Outcomes (2)

  • HRV

    Change from Baseline of HRV, immediately after each treatment

  • Lab Data

    Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment

Study Arms (3)

Routine care

EXPERIMENTAL

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

Other: Routine care

Routine care plus EA

EXPERIMENTAL

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 careProcedure: Electrical Acupuncture

Routine care plus TENS

EXPERIMENTAL

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 careProcedure: Transcutaneous Electrical Nerve Stimulation

Interventions

Routine careOTHER

Reverse pressure applied to the areola

Routine careRoutine care plus EARoutine care plus TENS
Electrical AcupuncturePROCEDURE

Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation

Routine care plus EA
Transcutaneous Electrical Nerve StimulationPROCEDURE

Transcutaneous electrical nerve stimulation over bil breasts

Routine care plus TENS

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Hung-Rong Yen, PhD

    Department of Chinese Medicine, China Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2017

First Posted

August 10, 2021

Study Start

September 12, 2017

Primary Completion

June 30, 2018

Study Completion

July 31, 2019

Last Updated

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)