이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

TENS for Postpartum Uterine Pain During Breastfeeding

2026년 8월 15일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

124

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Peak VAS pain score during breastfeeding in the second session
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Consumption of Pharmacological Analgesics
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: First 48 hours postpartum
Use of any infant formula in addition to breastfeeding
First 48 hours postpartum

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Raed Salim, M.D., Holy Family Hospital, Nazareth, Israel

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 15일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 25일

QC 기준을 충족하는 최초 제출

2026년 7월 11일

처음 게시됨 (실제)

2026년 7월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 15일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

After publication (starting 6 months after publication).

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다