Transcutaneous electrical nerve stimulation (TENS) for pain control during first-trimester procedural abortion: a blinded randomized controlled trial.

Andrea Henkel, Erica P Cahill, Sonia Chavez, Jade M Shorter, Serena M Liu, Stephanie I Amaya, Simranvir Kaur, Kate A Shaw
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Abstract

Objectives: To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) to manage pain during first-trimester procedural abortion for those not eligible for or otherwise forgoing sedation.

Study design: This is a double-blinded, block-randomized superiority trial (IRB approved, NCT05320432) comparing TENS (placed posteriorly, T10-L1 and S2-S4) to sham for pain management during first-trimester procedural abortion. We enrolled pregnant people less than 12 weeks gestation, English- or Spanish-speaking at two outpatient clinics not receiving sedation. The primary outcome was self-reported pain by visual analog scale (VAS, 100 mm) with passage of largest cervical dilator. We planned to enroll 70 patients to detect a 15 mm difference in median pain score (80% power, α = 0.05).

Results: Between January 2023 and March 2024, we enrolled 70 participants. Baseline demographics were balanced between groups: median (range) gestational duration 6 (5-11) weeks, 35.7% nulliparous. Median (range) reported pain with passage of largest dilator was 44mm (0-88) and 50mm (0-96) in the TENS and sham groups, respectively (p=0.56). We did not find a difference in median pain at any collected time point including placement of tenaculum, paracervical block, aspiration, or recovery. The active TENS group was more likely to say they would recommend this method of pain control to others (94mm vs 73mm, p=0.01). More participants receiving TENS unit correctly identified their group allocation (91.4% vs 63.6%, p<0.001).

Conclusion: While we did not demonstrate a difference in pain scores during the procedure, TENS is a non-pharmacologic alternative that may improve patient experience during uterine aspiration.

Implications: In a blinded randomized trial, the median pain scores reported during first-trimester procedure abortion did not differ between those receiving TENS or sham. However, those randomized to TENS were more likely to say they would recommend this method of pain control. For those with contraindications to IV sedation, improved experience may justify consideration of offering TENS during first-trimester abortion care.

经皮神经电刺激(TENS)对妊娠早期人工流产疼痛的控制:一项盲法随机对照试验。
目的:评价经皮神经电刺激(TENS)对不适合或放弃镇静的妊娠早期手术流产患者疼痛的治疗效果。研究设计:这是一项双盲、块随机优势试验(IRB批准,NCT05320432),比较TENS(放置在T10-L1和S2-S4的后方)与sham在妊娠早期手术流产期间疼痛管理的效果。我们招募了妊娠不足12周、英语或西班牙语的孕妇,在两家门诊诊所未接受镇静治疗。主要结果是通过视觉模拟量表(VAS, 100 mm)自我报告疼痛,并通过最大的宫颈扩张器。我们计划招募70名患者,以检测中位疼痛评分差异为15 mm(80%幂,α = 0.05)。结果:在2023年1月至2024年3月期间,我们招募了70名参与者。各组之间的基线人口统计数据平衡:中位(范围)妊娠持续时间为6(5-11)周,35.7%为无产。经最大扩张器通过时,TENS组和sham组的疼痛中位数(范围)分别为44mm(0-88)和50mm (0-96) (p=0.56)。我们没有发现在任何收集的时间点中位疼痛的差异,包括腱带放置,颈旁阻滞,抽吸或恢复。活跃的TENS组更有可能向其他人推荐这种疼痛控制方法(94mm vs 73mm, p=0.01)。结论:虽然我们没有证明手术过程中疼痛评分的差异,但TENS是一种非药物替代方法,可以改善患者在子宫抽吸过程中的体验。含义:在一项盲法随机试验中,妊娠早期人工流产中位疼痛评分在接受TENS或假手术的患者中没有差异。然而,那些随机分配到TENS的人更有可能说他们会推荐这种控制疼痛的方法。对于那些有静脉镇静禁忌症的人,改善经验可能证明在妊娠早期流产护理中提供TENS是合理的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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