An interventional study of Transcutaneous Electrical Nerve Stimulation (TENS) in Breast Feeding, sponsored by Holy Family Hospital, Nazareth, Israel. Recruiting at 2 sites in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Holy Family Hospital, Nazareth, Israel · Not applicable, Interventional, and Treatment
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.
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 80-Hz current and 200 msec pulse for 40 min, using 20-40 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.
Exclusion Criteria:
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)
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.
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 80-Hz current and 200 msec pulse for 40 min, using 20-40 mA of intensity. Stimulation begins a few minutes before breastfeeding and continues throughout the 40-minute session.
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).
Time frame: During the second breastfeeding session, within the first 48 hours postpartum
Consumption of Pharmacological Analgesics
Total dosage (mg) of pain relief medications consumed by the participant within the first 48 hours postpartum.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: First 48 hours postpartum
Formula use
Use of any infant formula in addition to breastfeeding
Time frame: First 48 hours postpartum
Plan to share: Yes — Individual patient data (IPD) that underlie results in a publication
Supporting information: Study protocol, Sap, Csr
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Holy Family Hospital, Nazareth, Israel