A Henkel, EP Cahill, S Chavez, JM Shorter, SM Liu, SI Amaya, S Kaur, KA Shaw
{"title":"经皮神经电刺激(Tens)用于控制第一胎程序性流产期间的疼痛:一项盲法随机对照试验","authors":"A Henkel, EP Cahill, S Chavez, JM Shorter, SM Liu, SI Amaya, S Kaur, KA Shaw","doi":"10.1016/j.contraception.2024.110617","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><div>We aimed 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 foregoing sedation.</div></div><div><h3>Methods</h3><div>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 who were 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 show a 15 mm difference in median pain score (80% power, α = 0.05).</div></div><div><h3>Results</h3><div>Between January 2023 and March 2024, we enrolled 70 participants. Baseline demographics were balanced between groups: median (range) gestational duration 6.8 (5.1-11.8) 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).</div></div><div><h3>Conclusions</h3><div>While we did not demonstrate a difference in pain during the procedure, TENS is a non-pharmacologic alternative that may improve patient experience during uterine aspiration.</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR PAIN CONTROL DURING FIRST-TRIMESTER PROCEDURAL ABORTION: A BLINDED RANDOMIZED CONTROLLED TRIAL\",\"authors\":\"A Henkel, EP Cahill, S Chavez, JM Shorter, SM Liu, SI Amaya, S Kaur, KA Shaw\",\"doi\":\"10.1016/j.contraception.2024.110617\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><div>We aimed 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 foregoing sedation.</div></div><div><h3>Methods</h3><div>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 who were 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 show a 15 mm difference in median pain score (80% power, α = 0.05).</div></div><div><h3>Results</h3><div>Between January 2023 and March 2024, we enrolled 70 participants. Baseline demographics were balanced between groups: median (range) gestational duration 6.8 (5.1-11.8) 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).</div></div><div><h3>Conclusions</h3><div>While we did not demonstrate a difference in pain during the procedure, TENS is a non-pharmacologic alternative that may improve patient experience during uterine aspiration.</div></div>\",\"PeriodicalId\":10762,\"journal\":{\"name\":\"Contraception\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contraception\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0010782424003123\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contraception","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0010782424003123","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR PAIN CONTROL DURING FIRST-TRIMESTER PROCEDURAL ABORTION: A BLINDED RANDOMIZED CONTROLLED TRIAL
Objectives
We aimed 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 foregoing sedation.
Methods
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 who were 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 show 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 6.8 (5.1-11.8) 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).
Conclusions
While we did not demonstrate a difference in pain during the procedure, TENS is a non-pharmacologic alternative that may improve patient experience during uterine aspiration.
期刊介绍:
Contraception has an open access mirror journal Contraception: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review.
The journal Contraception wishes to advance reproductive health through the rapid publication of the best and most interesting new scholarship regarding contraception and related fields such as abortion. The journal welcomes manuscripts from investigators working in the laboratory, clinical and social sciences, as well as public health and health professions education.