- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07703917
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Marwa Bayatra, MD
- Puhelinnumero: 97246508900
- Sähköposti: bayatra7@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: RAED SALIM, PROF
- Puhelinnumero: 97246508900
- Sähköposti: r.salim@hfhosp.org
Opiskelupaikat
-
-
-
Nazareth, Israel
- Rekrytointi
- Holy Family Hospital
-
Ottaa yhteyttä:
- Raed
- Sähköposti: r.salim@hfhosp.org
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Ei väliintuloa: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Peak VAS pain score during breastfeeding in the second session
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Consumption of Pharmacological Analgesics
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: First 48 hours postpartum
|
Use of any infant formula in addition to breastfeeding
|
First 48 hours postpartum
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojen puheenjohtaja: Raed Salim, M.D., Holy Family Hospital, Nazareth, Israel
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- HFH-321/2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .