Not provided
Not provided
Not provided
Not provided
No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine care | Experimental | Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. |
|
| Routine care plus EA | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care | Other | Reverse pressure applied to the areola |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity Index (0-19) | Sum of the degree of Erythema, Tension and Pain scores over breasts | Changes from Baselines of Severity Index, at each treatment and 1 month later |
| Measure | Description | Time Frame |
|---|---|---|
| EPDS | Edinburgh Postnatal Depression Scale | Changes from Baseline of EPDS, after each treatment and 1 month later |
| BSES-SF | Breastfeeding Self-Efficacy Scale |
| Measure | Description | Time Frame |
|---|---|---|
| HRV | Real-time handheld Heart-rate Variability | Change from Baseline of HRV, immediately after each treatment |
| Lab Data | Measurements of Oxytocin and Cortisol levels in breastmilk |
Inclusion Criteria:
Exclusion Criteria:
Postpartum women
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hung-Rong Yen, PhD | Department of Chinese Medicine, China Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Electrical Acupuncture | Procedure | Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation |
|
| Transcutaneous Electrical Nerve Stimulation | Procedure | Transcutaneous electrical nerve stimulation over bil breasts |
|
| Changes from Baseline of BEES-SF, after each treatment and 1 month later |
| Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |