TENS for Postpartum Uterine Pain During Breastfeeding

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHoly Family Hospital, Nazareth, Israel

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Maternal Age above 18

Term delivery (37 weeks or more)

Vaginal delivery within the past 48 hours.

Multiparous women (2 or more previous births)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: TENS GroupExperimental treatment 1 intervention
Group B: No-TENS Control GroupNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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