Breast FeedingNCT07703917
TENS for Postpartum Uterine Pain During Breastfeeding
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Breast Feeding, run by Holy Family Hospital, Nazareth, Israel at 2 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesIsrael
- Study dates
- 15 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Holy Family Hospital
Nazareth
Raed Salim, MD, r.salim@hfhosp.org
- Recruiting
Holy Family Hospital
Nazareth
Raed, r.salim@hfhosp.org
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Breast Feeding
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- BREASTFEEDING, TENS, POSTPARTUM PAIN
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the second breastfeeding session, within the first 48 hours postpartum
Secondary outcomes (6)
Consumption of Pharmacological Analgesics
Total dosage (mg) of pain relief medications consumed by the participant within the first 48 hours postpartum.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: First 48 hours postpartum
Formula use
Use of any infant formula in addition to breastfeeding
Measured: First 48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start15 Aug 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Family Hospital, Nazareth, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, MD, Holy Family Hospital, Nazareth, Israel
- Investigators
- Raed Salim, M.D., Study chair, Holy Family Hospital, Nazareth, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703917
- Sponsor's protocol ID
- HFH-321/2026
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) that underlie results in a publication
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.
PubMed 31614631Alswied 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.
PubMed 39743343Vera 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.
PubMed 19370073Kahila 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.
PubMed 17364281Radhakrishnan 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.
PubMed 12927629Silbert 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.
PubMed 24329649
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation for Treating Postpartum Uterine Pain During Breastfeeding in Multiparous Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07703917
- Acronym / sponsor ID
- HFH-321/2026
- Conditions
- Breast Feeding
- Keywords
- BREASTFEEDING, TENS, POSTPARTUM PAIN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Holy Family Hospital, Nazareth, IsraelUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | TENS Group |
Primary outcome
Peak VAS pain score during breastfeeding in the second session
Time frame: During the second breastfeeding session, within the first 48 hours postpartum
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).
6 secondary outcomes
Consumption of Pharmacological Analgesics
Time frame: First 48 hours postpartum
Peak VAS pain score during breastfeeding in the second compared with the first sessions.
Time frame: During two consecutive breastfeeding sessions within the first 48 hours postpartum
Duration of breastfeeding sessions.
Time frame: In the two consecutive breastfeeding sessions within the first 48 hours postpartum
Adverse effects related to TENS use
Time frame: During the second session, within the first 48 hours postpartum
Maternal discomfort
Time frame: First 48 hours postpartum
Formula use
Time frame: First 48 hours postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 31614631McKay TB, Priyadarsini S, Karamichos D. Mechanisms of Collagen Crosslinking in Diabetes and Keratoconus. Cells. 2019 Oct 11;8(10):1239. doi: 10.3390/cells8101239.
- Background: PubMed 39743343Alswied 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.
- Background: PubMed 19370073Vera 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.
- Background: PubMed 17364281Kahila 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.
- Background: PubMed 12927629Radhakrishnan 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.
- Background: PubMed 24329649Silbert 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.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raed Salim, M.D. study chair
Holy Family Hospital, Nazareth, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Breast Feeding, run by Holy Family Hospital, Nazareth, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Bayatra, MD (97246508900, bayatra7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VAS pain score during breastfeeding in the second session (time frame: During the second breastfeeding session, within the first 48 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07703917, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.