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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Marwa Bayatra, MD
- 電話番号:97246508900
- メール:bayatra7@gmail.com
研究連絡先のバックアップ
- 名前:RAED SALIM, PROF
- 電話番号:97246508900
- メール:r.salim@hfhosp.org
研究場所
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-
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Nazareth、イスラエル
- 募集
- Holy Family Hospital
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コンタクト:
- Raed
- メール:r.salim@hfhosp.org
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
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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.
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介入なし: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Peak VAS pain score during breastfeeding in the second session
時間枠:During the second breastfeeding session, within the first 48 hours postpartum
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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).
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During the second breastfeeding session, within the first 48 hours postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Consumption of Pharmacological Analgesics
時間枠:First 48 hours postpartum
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Total dosage (mg) of pain relief medications consumed by the participant within the first 48 hours postpartum.
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First 48 hours postpartum
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Peak VAS pain score during breastfeeding in the second compared with the first sessions.
時間枠:During two consecutive breastfeeding sessions within the first 48 hours postpartum
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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).
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During two consecutive breastfeeding sessions within the first 48 hours postpartum
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Duration of breastfeeding sessions.
時間枠:In the two consecutive breastfeeding sessions within the first 48 hours postpartum
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The time, in minutes, that the woman is able to continue breastfeeding.
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In the two consecutive breastfeeding sessions within the first 48 hours postpartum
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Adverse effects related to TENS use
時間枠:During the second session, within the first 48 hours postpartum
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Local adverse effects related to TENS in the intervention group.
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During the second session, within the first 48 hours postpartum
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Maternal discomfort
時間枠:First 48 hours postpartum
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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).
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First 48 hours postpartum
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Formula use
時間枠:First 48 hours postpartum
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Use of any infant formula in addition to breastfeeding
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First 48 hours postpartum
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協力者と研究者
捜査官
- スタディチェア:Raed Salim, M.D.、Holy Family Hospital, Nazareth, Israel
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HFH-321/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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