TENS for Postpartum Uterine Pain During Breastfeeding

Transcutaneous Electrical Nerve Stimulation for Treating Postpartum Uterine Pain During Breastfeeding in Multiparous Women: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Feeding
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Detailed Description

This randomized, controlled, parallel-group clinical trial will evaluate the efficacy and safety of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological intervention for reducing oxytocin-induced postpartum uterine contractions during breastfeeding. The study cohort consists of 124 eligible multiparous women (2 or more previous births) admitted to the Department of Obstetrics and Gynecology at Holy Family Hospital in Nazareth, Israel, within 48 hours following a term, singleton, vaginal delivery. Following the acquisition of written informed consent, participants will be randomized at a 1:1 ratio into either the TENS study group or the standard care control group. The experimental protocol will be integrated into two consecutive breastfeeding sessions. Body positioning will be strictly standardized across both cohorts. TENS Study Group (Intervention): Prior to the second consecutive breastfeeding session, four conductive gel electrodes will be affixed to the participant. Two electrodes will be positioned bilaterally over the lower abdomen, directly overlying the uterus. The remaining two electrodes will be placed in parallel in the S2-S4 dermatomal region to target the spinal nerve pathways receiving nociceptive afferent input from the uterus and cervix. Active stimulation will commence a few minutes prior to breastfeeding and continue for the entire duration of the feed. The TENS device will deliver a 100-Hz current and 75 msec pulse for 40 min, using 20-60 milliamps of intensity.

To establish a baseline pain score, the first evaluated breastfeeding session for this group will be conducted without TENS application, followed by active TENS during the second session. Control Group Protocol: Participants assigned to the control group will receive standard postpartum care and will undergo the identical data collection schedule across two consecutive breastfeeding sessions, but without any TENS electrode placement or electrical stimulation.

For both study arms, pharmacological analgesia will remain accessible as needed per existing institutional department protocols, and all instances of medication administration (including specific agent, timing, and dosage) will be precisely documented. Uterine pain scores will be captured across both groups at three identical time points during each of the two consecutive breastfeeding sessions: Maternal discomfort associated directly with the physical application or sensation of the TENS unit will be separately quantified.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Bayatra, MD; Phone Number: 97246508900; Email: bayatra7@gmail.com
• Study Contact Backup: Name: RAED SALIM, PROF; Phone Number: 97246508900; Email: r.salim@hfhosp.org

Study Locations

• Israel
  • Nazareth, Israel
    • Holy Family Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS Group; 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); 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.
No Intervention: No-TENS Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of Pharmacological Analgesics	Total dosage (mg) of pain relief medications consumed by the participant within the first 48 hours postpartum.	First 48 hours postpartum
Peak VAS pain score during breastfeeding in the second compared with the first sessions.	The maximum VAS score in the first and second session will be recorded and compared within the same group. 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 two consecutive breastfeeding sessions within the first 48 hours postpartum
Duration of breastfeeding sessions.	The time, in minutes, that the woman is able to continue breastfeeding.	In the two consecutive breastfeeding sessions within the first 48 hours postpartum
Adverse effects related to TENS use	Local adverse effects related to TENS in the intervention group.	During the second session, within the first 48 hours postpartum
Maternal discomfort	The women will also be asked to estimate the discomfort of the TENS use using a 5-point verbal scale from no discomfort (0) to worst possible discomfort (5).	First 48 hours postpartum
Formula use	Use of any infant formula in addition to breastfeeding	First 48 hours postpartum

Collaborators and Investigators

• Sponsor: Holy Family Hospital, Nazareth, Israel
• Investigators: Study Chair: Raed Salim, M.D., Holy Family Hospital, Nazareth, Israel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: TENS; BREASTFEEDING; POSTPARTUM PAIN
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: HFH-321/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data (IPD) that underlie results in a publication
• IPD Sharing Time Frame: After publication (starting 6 months after publication).
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No