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

Post Partum Depression Clinical Trial

— ETBEG  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04998565
• Other study ID #: CMUH106-REC1-101
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression, Postpartum
• Hyperemia
• Post Partum Depression

Intervention

Other:
• Routine care
Reverse pressure applied to the areola

Procedure:
• Electrical Acupuncture
Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
• Transcutaneous Electrical Nerve Stimulation
Transcutaneous electrical nerve stimulation over bil breasts

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HRV	Real-time handheld Heart-rate Variability	Change from Baseline of HRV, immediately after each treatment
Other	Lab Data	Measurements of Oxytocin and Cortisol levels in breastmilk	Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment
Primary	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
Secondary	EPDS	Edinburgh Postnatal Depression Scale	Changes from Baseline of EPDS, after each treatment and 1 month later
Secondary	BSES-SF	Breastfeeding Self-Efficacy Scale	Changes from Baseline of BEES-SF, after each treatment and 1 month later