Transcutaneous Electrical Nerve Stimulation for Treating Postpartum Uterine Pain During Breastfeeding in Multiparous Women: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Peak VAS pain score during breastfeeding in the second session
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
结局指标
主要结局
Peak VAS pain score during breastfeeding in the second session
时间窗: 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).
次要结局
- Consumption of Pharmacological Analgesics(First 48 hours postpartum)
- Peak VAS pain score during breastfeeding in the second compared with the first sessions.(During two consecutive breastfeeding sessions within the first 48 hours postpartum)
- Duration of breastfeeding sessions.(In the two consecutive breastfeeding sessions within the first 48 hours postpartum)
- Adverse effects related to TENS use(During the second session, within the first 48 hours postpartum)
- Maternal discomfort(First 48 hours postpartum)
- Formula use(First 48 hours postpartum)
研究者
Raed Salim, MD
PROFESSOR
Holy Family Hospital, Nazareth, Israel