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

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04998565
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 3
• Actual Duration (Months): 22.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Engorgement in Puerperium; Post Partum Depression	Other: Routine care; Procedure: Electrical Acupuncture; Procedure: Transcutaneous Electrical Nerve Stimulation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 12, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Routine care Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.	Other: Routine care; Reverse pressure applied to the areola
Experimental: Routine care plus EA 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	Other: Routine care; Reverse pressure applied to the areola; Procedure: Electrical Acupuncture; Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
Experimental: Routine care plus TENS 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	Other: Routine care; Reverse pressure applied to the areola; Procedure: Transcutaneous Electrical Nerve Stimulation; Transcutaneous electrical nerve stimulation over bil breasts

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. EPDS [Changes from Baseline of EPDS, after each treatment and 1 month later]

   Edinburgh Postnatal Depression Scale

2. BSES-SF [Changes from Baseline of BEES-SF, after each treatment and 1 month later]

   Breastfeeding Self-Efficacy Scale

Other Outcome Measures

1. HRV [Change from Baseline of HRV, immediately after each treatment]

   Real-time handheld Heart-rate Variability

2. Lab Data [Changes from Baseline of Oxytocin and Cortisol levels, immediately after each treatment]

   Measurements of Oxytocin and Cortisol levels in breastmilk

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan

Sponsors and Collaborators

• China Medical University Hospital

Investigators

• Study Chair: Hung-Rong Yen, PhD, Department of Chinese Medicine, China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT04998565
• Other Study ID Numbers: CMUH106-REC1-101
• First Posted: Aug 10, 2021
• Last Update Posted: Aug 10, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China Medical University Hospital: Electrical acupuncture; Transcutaneous Electrical Nerve Stimulation
• Additional relevant MeSH terms: Depression, Postpartum; Hyperemia

Study Results

No Results Posted as of Aug 10, 2021