Clinical trial NCT04998565: Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement
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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Engorgement in Puerperium
Post Partum Depression
Keywords: Electrical acupuncture
Transcutaneous Electrical Nerve Stimulation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity Index (0-19)
timeFrame: Changes from Baselines of Severity Index, at each treatment and 1 month later
Secondary outcomes:
measure: EPDS
timeFrame: Changes from Baseline of EPDS, after each treatment and 1 month later
measure: BSES-SF
timeFrame: Changes from Baseline of BEES-SF, after each treatment and 1 month later
Other outcomes:
measure: HRV
timeFrame: Change from Baseline of HRV, immediately after each treatment
measure: Lab Data
timeFrame: Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Department of Chinese Medicine, China Medical University
name: Hung-Rong Yen, PhD
role: STUDY_CHAIR
References: