NCT04998565

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Engorgement in Puerperium
• Post Partum Depression

Interventions

Type	Name	Description
OTHER	Routine care	Reverse pressure applied to the areola
PROCEDURE	Electrical Acupuncture	Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
PROCEDURE	Transcutaneous Electrical Nerve Stimulation	Transcutaneous electrical nerve stimulation over bil breasts

Timeline

• Start date: 2017-09-12
• Primary completion: 2018-06-30
• Completion: 2019-07-31
• First posted: 2021-08-10
• Last updated: 2021-08-10

Locations

1 site across 1 country: Taiwan