Breast Engorgement in Puerperium, Post Partum Depression
Conditions
Keywords
Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation
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.
Interventions
OTHERRoutine care
Reverse pressure applied to the areola
PROCEDUREElectrical Acupuncture
Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
PROCEDURETranscutaneous Electrical Nerve Stimulation
Transcutaneous electrical nerve stimulation over bil breasts
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| HRV | Change from Baseline of HRV, immediately after each treatment | Real-time handheld Heart-rate Variability |
| Lab Data | Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment | Measurements of Oxytocin and Cortisol levels in breastmilk |
Countries
Taiwan
Outcome results
None listed