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

China Medical University

Status: Terminated

Conditions: Breast Engorgement in Puerperium; Post Partum Depression

Treatments: Procedure: Electrical Acupuncture; Procedure: Transcutaneous Electrical Nerve Stimulation; Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT04998565

CMUH106-REC1-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 3 patient groups

Routine care

Experimental group

Description:

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

Treatment:

Other: Routine care

Routine care plus EA

Experimental group

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

Treatment:

Procedure: Electrical Acupuncture

Other: Routine care

Routine care plus TENS

Experimental group

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

Treatment:

Other: Routine care

Procedure: Transcutaneous Electrical Nerve Stimulation