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

Not Applicable

Terminated

• Conditions: Post Partum Depression; Breast Engorgement in Puerperium
• Interventions: Other: Routine care; Procedure: Transcutaneous Electrical Nerve Stimulation; Procedure: Electrical Acupuncture

• Registration Number: NCT04998565
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2017-10-08
• Primary Completion: 2018-06-30
• Study Completion: 2019-07-31
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care plus TENS	Routine care	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
Routine care	Routine care	Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.
Routine care plus EA	Routine care	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 plus TENS	Transcutaneous Electrical Nerve Stimulation	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
Routine care plus EA	Electrical Acupuncture	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

Primary Outcome Measures

Name	Time	Method
Severity Index (0-19)	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

Secondary Outcome Measures

Name	Time	Method
EPDS	Changes from Baseline of EPDS, after each treatment and 1 month later	Edinburgh Postnatal Depression Scale
BSES-SF	Changes from Baseline of BEES-SF, after each treatment and 1 month later	Breastfeeding Self-Efficacy Scale

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan