TENS for Postpartum Uterine Pain During Breastfeeding

NCT07703917 | Not Yet Recruiting DMC

• 1 other identifier: HFH-321/2026
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, non-drug method to relieve postpartum uterine pain during breastfeeding in multiparous women (women who have given birth multiple times). Breastfeeding in the first 48 hours after delivery often triggers strong, painful uterine contractions due to the natural release of oxytocin. While standard care typically relies on pain-relief medications, this study investigates if TENS, a safe, low-cost device that sends gentle electrical impulses through small skin patches, can significantly reduce this pain and decrease the need for systemic medications. Participants will be randomly assigned to either receive standard postpartum pain medications or use a TENS device during two consecutive breastfeeding sessions. Researchers will measure and compare the peak pain levels between both groups using a standard 0 to 10 pain scale. The aim is examining whether TENS will significantly reduce postpartum uterine pain during breastfeeding and decrease medication use compared with standard care.

Conditions

Breast Feeding

Keywords

BREASTFEEDING; TENS; POSTPARTUM PAIN

Outcome Measures

Primary Outcomes (1)

• Peak VAS pain score during breastfeeding in the second session

  The maximum VAS score recorded will be compared between groups. Postpartum uterine pain during breastfeeding will be evaluated using a standard Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

  During the second breastfeeding session, within the first 48 hours postpartum

Secondary Outcomes (6)

• Consumption of Pharmacological Analgesics

  First 48 hours postpartum

• Peak VAS pain score during breastfeeding in the second compared with the first sessions.

  During two consecutive breastfeeding sessions within the first 48 hours postpartum

• Duration of breastfeeding sessions.

  In the two consecutive breastfeeding sessions within the first 48 hours postpartum

• Adverse effects related to TENS use

  During the second session, within the first 48 hours postpartum

• Maternal discomfort

  First 48 hours postpartum

Study Arms (2)

TENS Group

EXPERIMENTAL

This arm is receiving the active clinical intervention being evaluated in the study (the TENS device). Pain scores will be assessed during two consecutive breastfeeding sessions. The first with, and the second without TENS.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

No-TENS Control Group

NO INTERVENTION

Participants assigned to this control group will receive standard postpartum care only, without any TENS application. Pain scores will be assessed during two consecutive breastfeeding sessions within the first 48 hours postpartum to serve as a comparative baseline against the intervention group.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Bilateral application of four skin electrodes using conductive gel. Two electrodes will be placed on the lower abdomen over the uterus, and two will be placed in parallel in the S2-S4 sacral region. The digital sensory-motor TENS device will be programmed to generate a 100-Hz current and 75 msec pulse for 40 min, using 20-60 mA of intensity. Stimulation begins a few minutes before breastfeeding and continues throughout the 40-minute session.

TENS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal Age above 18
• Term delivery (37 weeks or more)
• Vaginal delivery within the past 48 hours.
• Multiparous women (2 or more previous births)
• Delivery of a singleton
• Have the well to breastfeed

You may not qualify if:

• Contraindication to TENS (pacemaker, epilepsy, active infection, uncontrolled hyper / hypotension.)
• Chronic analgesia use
• Severe complications requiring intervention (severe PPH) or intensive care
• Skin lesions, infections, or scars at proposed electrode sites
• Neonatal intensive care unit admission

Sponsors & Collaborators

• Holy Family Hospital, Nazareth, Israel: lead

Study Sites (1)

Holy Family Hospital

Nazareth, Israel

Location

Related Publications (6)

• McKay TB, Priyadarsini S, Karamichos D. Mechanisms of Collagen Crosslinking in Diabetes and Keratoconus. Cells. 2019 Oct 11;8(10):1239. doi: 10.3390/cells8101239.

  PMID: 31614631 BACKGROUND

• Alswied A, Chen LN, West-Mitchell KA. Longitudinal assessment of erythrogram parameters in response to granulocytapheresis frequency: A sex-based analysis. Vox Sang. 2025 Mar;120(3):268-276. doi: 10.1111/vox.13788. Epub 2025 Jan 1.

  PMID: 39743343 BACKGROUND

• Vera Pingitore E, Hebert EM, Sesma F, Nader-Macias ME. Influence of vitamins and osmolites on growth and bacteriocin production by Lactobacillus salivarius CRL 1328 in a chemically defined medium. Can J Microbiol. 2009 Mar;55(3):304-10. doi: 10.1139/w08-092.

  PMID: 19370073 BACKGROUND

• Kahila H, Saisto T, Kivitie-Kallio S, Haukkamaa M, Halmesmaki E. A prospective study on buprenorphine use during pregnancy: effects on maternal and neonatal outcome. Acta Obstet Gynecol Scand. 2007;86(2):185-90. doi: 10.1080/00016340601110770.

  PMID: 17364281 BACKGROUND

• Radhakrishnan R, Moore SA, Sluka KA. Unilateral carrageenan injection into muscle or joint induces chronic bilateral hyperalgesia in rats. Pain. 2003 Aug;104(3):567-577. doi: 10.1016/S0304-3959(03)00114-3.

  PMID: 12927629 BACKGROUND

• Silbert BI, Lam SJ, Henderson RD, Lake FR. Students as teachers. Med J Aust. 2013 Dec 16;199(11):757. doi: 10.5694/mja13.11353. No abstract available.

  PMID: 24329649 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Raed Salim, M.D.

  Holy Family Hospital, Nazareth, Israel

  STUDY CHAIR

Central Study Contacts

Marwa Bayatra, MD

CONTACT

97246508900; bayatra7@gmail.com

RAED SALIM, PROF

CONTACT

97246508900; r.salim@hfhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication (starting 6 months after publication).
• Access Criteria: De-identified IPD will be available to academic or clinical researchers for meta-analyses, and research addressing questions related to the study topic. Requests must include a research protocol, statistical analysis plan, ethics approval, and details of the research team. Requests will be reviewed by the principal investigator. Data will be provided after approval and completion of a data-sharing agreement.

Locations

IL (1)