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TENS for Postpartum Uterine Pain During Breastfeeding

15 août 2026 mis à jour par: Raed Salim, MD, Holy Family Hospital, Nazareth, Israel

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

124

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Peak VAS pain score during breastfeeding in the second session
Délai: 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).
During the second breastfeeding session, within the first 48 hours postpartum

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Consumption of Pharmacological Analgesics
Délai: First 48 hours postpartum
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.
Délai: During two consecutive breastfeeding sessions within the first 48 hours postpartum
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.
Délai: In the two consecutive breastfeeding sessions within the first 48 hours postpartum
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
Délai: During the second session, within the first 48 hours postpartum
Local adverse effects related to TENS in the intervention group.
During the second session, within the first 48 hours postpartum
Maternal discomfort
Délai: First 48 hours postpartum
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
Délai: First 48 hours postpartum
Use of any infant formula in addition to breastfeeding
First 48 hours postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Raed Salim, M.D., Holy Family Hospital, Nazareth, Israel

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 août 2026

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

25 juin 2026

Première soumission répondant aux critères de contrôle qualité

11 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Description du régime IPD

Individual patient data (IPD) that underlie results in a publication

Délai de partage IPD

After publication (starting 6 months after publication).

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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