TENS Unit for Analgesia During IUD Insertion

Официальное название

Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study

Обзор

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during IUD insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * IUD insertion * 5 minutes after IUD insertion Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only. As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.

Вмешательства

• Устройство TENS (transcutaneous electrical nerve stimulation) unit
  Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current. A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.
• Другое Standard care
  Paracervical block only or participant declines analgesia for IUD insertion

Первичные конечные точки

• Self reported pain intensity from participants during IUD insertion [Срок оценки: Day 1]

Вторичные конечные точки (3)

• Pain at other time points during IUD insertion procedure [Срок оценки: Day 1]
• Rate of vasovagal responses [Срок оценки: Day 1]
• Likelihood to recommend pain management regiment to a friend for same procedure [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Persons with a uterus desiring insertion of intrauterine device
• Able to provide informed consent/assent
• Age 12-50 years old
• Minors 12 years of age and older will be included in the study if postmenarchal

Критерии исключения

• Unable to provide informed consent/assent
• Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
• Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
• Cutaneous damage at the TENS electrode sites
• Chronic or pre-procedure use of opioids
• Chronic pain diagnosis
• Prior IUD insertion
• Any contraindication to intrauterine device (IUD):

• Pregnancy
• Uterine anomaly that distorts the uterine cavity
• Acute pelvic inflammatory disease (PID)
• Postpartum endometritis or infected abortion in the past 3 months
• Unexplained abnormal uterine bleeding
• Wilson's disease or copper allergy (contraindication to copper IUD only)
• Breast cancer (contraindication to levonorgestrel IUD only

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Tufts Medical Center — Boston

Публикации

• Potter J, Rubin SE, Sherman P. Fear of intrauterine contraception among adolescents in New York City. Contraception. 2014 May;89(5):446-50. doi: 10.1016/j.contraception.2014.01.011. Epub 2014 Jan 21. PMID 24560479
• Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170. PMID 16824298
• Fleming KL, Sokoloff A, Raine TR. Attitudes and beliefs about the intrauterine device among teenagers and young women. Contraception. 2010 Aug;82(2):178-82. doi: 10.1016/j.contraception.2010.02.020. Epub 2010 Apr 13. PMID 20654760
• Kavanaugh ML, Frohwirth L, Jerman J, Popkin R, Ethier K. Long-acting reversible contraception for adolescents and young adults: patient and provider perspectives. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):86-95. doi: 10.1016/j.jpag.2012.10.006. Epub 2012 Dec 31. PMID 23287602
• Callahan DG, Garabedian LF, Harney KF, DiVasta AD. Will it Hurt? The Intrauterine Device Insertion Experience and Long-Term Acceptability Among Adolescents and Young Women. J Pediatr Adolesc Gynecol. 2019 Dec;32(6):615-621. doi: 10.1016/j.jpag.2019.08.004. Epub 2019 Aug 8. PMID 31401254
• ACOG Committee Opinion No. 735: Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2018 May;131(5):e130-e139. doi: 10.1097/AOG.0000000000002632. PMID 29683910
• American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice; Long-Acting Reversible Contraceptive Expert Work Group. Committee Opinion No 672: Clinical Challenges of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2016 Sep;128(3):e69-77. doi: 10.1097/AOG.0000000000001644. PMID 27548557
• Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18. PMID 28826645

Идентификаторы

NCT: NCT06240260 · STUDY00004077

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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